The Impact of Burnout on Patient-Centered Care: A Comparative Effectiveness Trial in Mental Health
Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT02146326
Collaborator
Four County Counseling Center (Other), Places for People (Other), Patient-Centered Outcomes Research Institute (Other)
679
2
4
30
339.5
11.3
Study Details
Study Description
Brief Summary
Healthcare providers play an important role in helping patients be actively involved in treatment and recover from mental illness. But mental health clinicians, like other healthcare providers, are at risk for experiencing burnout-feeling emotionally drained from their work, having cynical thoughts toward patients and others, and feeling little accomplishment in their work. Burnout can lead to problems for the clinician including poor overall health, depression, and lower job satisfaction. Burnout also can impact how clinicians perform on the job; for example, people with high levels of burnout take more time off, show lower commitment to their job, and are more likely to quit or be fired. There is some evidence that burnout can affect the quality of care for patients, but very little rigorous research has tested this assumption. The purpose of our study is threefold. First, we will investigate how patients perceive burnout in clinicians and whether (and/or how) burnout impacts the care they receive. Next, we will test an intervention to reduce clinician burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar with, including relaxation and mindfulness exercises, setting boundaries, using social supports, and changing negative thought patterns and replacing them with more helpful ways of thinking. We have found this intervention effective in reducing burnout in other organizations, but have yet to study whether it also can improve patient outcomes. Clinicians (approximately 200) who participate will receive either the BREATHE intervention or training in motivational interviewing, which could also improve patient involvement in treatment and patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also recruit up to 600 adult patients served by participating clinicians. We will survey clinicians and interview patients over a 12-month period after the intervention to determine how the intervention impacts clinician burnout and patient perceptions of care (relationship with the clinician, degree of autonomy in decision making), patient involvement in care, and outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally, this study will use a statistical procedure called Structural Equation Modeling to test a theoretical model of the relationship between burnout and patient outcomes. Findings from this study will show whether reducing clinician burnout can improve patient outcomes and the quality of care that patients receive. Our intervention will have the potential to be easily implemented in a variety of settings where burnout is a problem. Knowing how clinician burnout impacts patient outcomes, and whether improving burnout can improve patient care, can help improve the healthcare system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
679 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Impact of Burnout on Patient-Centered Care: A Comparative Effectiveness Trial in Mental Health
Study Start Date
:
Dec 1, 2013
Actual Primary Completion Date
:
Apr 1, 2016
Actual Study Completion Date
:
Jun 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Motivational Interviewing-Mental Health Staff
|
Behavioral: Motivational Interviewing (MI)
MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart.
|
| Active Comparator: BREATHE-Mental Health Staff
|
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart.
|
| Active Comparator: Motivational Interviewing-Clients
|
Behavioral: Motivational Interviewing (MI)
MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart.
|
| Active Comparator: BREATHE-Clients
|
Behavioral: Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)
BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart.
|
Outcome Measures
Primary Outcome Measures
- Maslach Burnout Inventory (MBI): Emotional Exhaustion [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
- Maslach Burnout Inventory (MBI): Depersonalization [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
- Maslach Burnout Inventory (MBI): Personal Accomplishment [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996.
Secondary Outcome Measures
- Job Satisfaction [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree) Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974.
- Turnover Intentions-Considered Leaving [Measured with staff at baseline, 3 months, 6 months, and 12 months]
This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, "How often have you seriously considered leaving your job in the past six months?" Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week)
- Turnover Intentions-Likely to Leave [Measured with staff at baseline, 3 months, 6 months, and 12 months]
This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, "How likely are you to leave your job in the next six months?" Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely)
- Work Interference With Home Life [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged. Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276.
- Home Life Interference With Work [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged. Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276.
- Emotional Labor Scale: Surface Acting [Measured with staff at baseline, 3 months, 6 months, and 12 months]
The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Emotional Labor Scale: Deep Acting [Measured with staff at baseline, 3 months, 6 months, and 12 months]
The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Emotional Labor Scale: Genuine Emotions [Measured with staff at baseline, 3 months, 6 months, and 12 months]
The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)
- Importance: Reduce Work-Related Stress [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Staff were asked, "How important is it for you to reduce your work-related stress right now?" This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important)
- Confidence: Reduce Work-Related Stress [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Staff were asked, "How confident are you that you can reduce your work-related stress in your life?" Scale: 1 (not at all confident) to 10 (extremely confident)
- Importance: Client Interaction [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Staff were asked, "How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all important) to 10 (extremely important)
- Confidence: Client Interaction [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Staff were asked, "How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all confident) to 10 (extremely confident)
- Quality of Care: Person Centered Care [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care: Discordant Care [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Total [Measured with staff at baseline, 3 months, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always)
- Perceptions of Supervisory Support [Measured with staff at baseline, 3 months, 6 months, and 12 months]
The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always)
- Staff Turnover [Measured with staff at 12 months]
Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants.
- Adult State Hope Scale [Measured with clients at baseline, 6 months, and 12 months]
Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True) Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335.
- Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item [Measured with clients at baseline, 6 months, and 12 months]
Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes) Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247.
- Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item [Measured with clients at baseline, 6 months, and 12 months]
Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes) Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247.
- Health-Care Climate Questionnaire [Measured with clients at baseline, 6 months, and 12 months]
Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree) Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45.
- Working Alliance Inventory (WAI) [Measured with clients at baseline, 6 months, and 12 months]
Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Tasks Subscale [Measured with clients at baseline, 6 months, and 12 months]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Goals Subscale [Measured with clients at baseline, 6 months, and 12 months]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Working Alliance Inventory (WAI) - Bonds Subscale [Measured with clients at baseline, 6 months, and 12 months]
Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207.
- Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale [Measured with clients at baseline, 6 months, and 12 months]
Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930.
- Short-Form Health Survey (SF-12)-Physical Health Functioning [Measured with clients at baseline, 6 months, and 12 months]
Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100). Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233.
- Short-Form Health Survey (SF-12)-Mental Health Functioning [Measured with clients at baseline, 6 months, and 12 months]
Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100). Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233.
- Patient Health Questionnaire 9-item (PHQ-9) [Measured with clients at baseline, 6 months, and 12 months]
The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult). Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613. American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000.
- Generalized Anxiety Disorder (GAD-7) [Measured with clients at baseline, 6 months, and 12 months]
Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day) Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097. Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325.
- Client Satisfaction Questionnaire [Measured with clients at baseline, 6 months, and 12 months]
Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied).
- Quality of Care-Person Centered Care [Measured with clients at baseline, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Negative Interactions [Measured with clients at baseline, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care-Inattentive Care [Measured with clients at baseline, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Quality of Care Total [Measured with clients at baseline, 6 months, and 12 months]
Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always)
- Patient Engagement-Missed Appointments [Measured with clients at baseline, 6 months, and 12 months]
Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A staff member with client contact at either Four County Counseling or Places for People.
-
Randomly chosen client from the participating staff lists. Must be 18 years old or older.
Exclusion Criteria:
- Clients younger than 18 years old.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Four County Counseling Center | Logansport | Indiana | United States | 46947 |
| 2 | Places for People | St. Louis | Missouri | United States | 63108 |
Sponsors and Collaborators
- Indiana University
- Four County Counseling Center
- Places for People
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Michelle P Salyers, PhD, Indiana University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Michelle Salyers,
Professor, Department of Psychology,
Indiana University
ClinicalTrials.gov Identifier:
NCT02146326
Other Study ID Numbers:
- IH-1304-6597
First Posted:
May 23, 2014
Last Update Posted:
Apr 14, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Staff and clients were recruited from 2 community mental health centers. Up to 5 clients for each participating staff with adult caseloads were recruited. Enrollment occurred over 3 waves of recruitment at 2 sites between 2/24/2014 and 3/18/2016. Totals of 206 staff and 473 clients completed informed consent to participate. |
|---|---|
| Pre-assignment Detail | Mental Health Care Staff: 206 completed informed consent: 14 were not randomized (12 did not complete the baseline survey, 1 withdrew, 1 resigned), 192 staff were randomized Mental Health Clients: 473 clients completed informed consent: 4 were not linked to randomized staff (3 screen failures, 1 linked to staff not randomized), |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the Motivational Interviewing (MI) intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Period Title: Overall Study | ||||
| STARTED | 89 | 103 | 211 | 258 |
| Baseline | 89 | 103 | 211 | 258 |
| 3 Months | 71 | 83 | 0 | 0 |
| 6 Months | 71 | 71 | 186 | 235 |
| 12 Months | 61 | 66 | 168 | 210 |
| COMPLETED | 61 | 66 | 168 | 210 |
| NOT COMPLETED | 28 | 37 | 43 | 48 |
Baseline Characteristics
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Total of all reporting groups |
| Overall Participants | 89 | 103 | 211 | 258 | 661 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
41.3
(12.5)
|
39.5
(12.0)
|
40.3
(12.2)
|
||
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
45.2
(13.6)
|
45.2
(12.7)
|
45.2
(13.1)
|
||
| Sex: Female, Male (Count of Participants) | |||||
| Female |
64
71.9%
|
89
86.4%
|
104
49.3%
|
138
53.5%
|
395
59.8%
|
| Male |
25
28.1%
|
14
13.6%
|
107
50.7%
|
120
46.5%
|
266
40.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| African American |
13
14.6%
|
6
5.8%
|
84
39.8%
|
118
45.7%
|
221
33.4%
|
| White |
71
79.8%
|
91
88.3%
|
115
54.5%
|
129
50%
|
406
61.4%
|
| Other |
4
4.5%
|
6
5.8%
|
12
5.7%
|
9
3.5%
|
31
4.7%
|
| Missing/Unknown |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.2%
|
| Education (Staff) (Count of Participants) | |||||
| Bachelors degree or above |
69
77.5%
|
88
85.4%
|
157
74.4%
|
||
| Less than bachelors degree |
20
22.5%
|
14
13.6%
|
34
16.1%
|
||
| Missing/Unknown |
0
0%
|
1
1%
|
1
0.5%
|
||
| Education (Clients) (Count of Participants) | |||||
| Completed at least high school/GED |
150
168.5%
|
178
172.8%
|
328
155.5%
|
||
| Less than high school/GED |
61
68.5%
|
80
77.7%
|
141
66.8%
|
||
| Years in position (Staff) (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
3.5
(4.7)
|
3.1
(4.7)
|
3.3
(4.7)
|
||
| Years at agency (Staff) (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
4.8
(5.7)
|
5.3
(6.7)
|
5.0
(6.3)
|
||
| Percentage of interactions with adult clients (Staff) (Count of Participants) | |||||
| Count of Participants [Participants] |
80
89.9%
|
94
91.3%
|
174
82.5%
|
||
| Years in field (Staff) (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
9.4
(9.2)
|
8.4
(8.8)
|
8.9
(9.0)
|
||
| Hours of burnout training in past year (Staff) (hours) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [hours] |
0.7
(3.4)
|
0.8
(2.4)
|
0.8
(2.9)
|
||
| Hours of motivational interviewing training in past year (Staff) (hours) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [hours] |
3.1
(8.2)
|
1.9
(4.5)
|
2.5
(6.5)
|
||
| Official number of work hours (Staff) (hours) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [hours] |
39.1
(4.6)
|
38.5
(5.4)
|
38.8
(5.0)
|
||
| Actual number of work hours (Staff) (hours) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [hours] |
41.6
(6.4)
|
41.6
(7.0)
|
41.6
(6.7)
|
||
| Employment (Clients) (Count of Participants) | |||||
| Paid employment |
26
29.2%
|
36
35%
|
62
29.4%
|
||
| Other |
185
207.9%
|
222
215.5%
|
407
192.9%
|
||
| Housing (Clients) (Count of Participants) | |||||
| Independent living |
143
160.7%
|
161
156.3%
|
304
144.1%
|
||
| Other |
68
76.4%
|
97
94.2%
|
165
78.2%
|
||
| Required to attend treatment (Clients) (Count of Participants) | |||||
| Yes, required to attend treatment |
0
0%
|
0
0%
|
30
14.2%
|
50
19.4%
|
80
12.1%
|
| No, not required or unknown/refused |
0
0%
|
0
0%
|
181
85.8%
|
208
80.6%
|
389
58.9%
|
| Wants to attend treatment (Clients) (Count of Participants) | |||||
| Yes, want to attend treatment |
0
0%
|
0
0%
|
197
93.4%
|
236
91.5%
|
433
65.5%
|
| No, does not want or unknown/refused |
0
0%
|
0
0%
|
14
6.6%
|
22
8.5%
|
36
5.4%
|
| Primary Diagnosis Category (Clients) (Count of Participants) | |||||
| Anxiety Disorder |
19
21.3%
|
12
11.7%
|
31
14.7%
|
||
| Bipolar Disorder |
35
39.3%
|
45
43.7%
|
80
37.9%
|
||
| Major Depression |
55
61.8%
|
53
51.5%
|
108
51.2%
|
||
| Other |
8
9%
|
12
11.7%
|
20
9.5%
|
||
| Schizophrenia |
86
96.6%
|
127
123.3%
|
213
100.9%
|
||
| Missing/Unknown |
8
9%
|
9
8.7%
|
17
8.1%
|
||
| Substance Use (Clients) (Count of Participants) | |||||
| Substance Use Not Present |
142
159.6%
|
169
164.1%
|
311
147.4%
|
||
| Substance Use Present |
60
67.4%
|
80
77.7%
|
140
66.4%
|
||
| Missing/Unknown |
9
10.1%
|
9
8.7%
|
18
8.5%
|
||
Outcome Measures
| Title | Maslach Burnout Inventory (MBI): Emotional Exhaustion |
|---|---|
| Description | Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
2.3
(1.3)
|
2.7
(1.3)
|
||
| 3 months |
2.3
(1.2)
|
2.7
(1.4)
|
||
| 6 months |
2.5
(1.4)
|
2.6
(1.3)
|
||
| 12 months |
2.4
(1.2)
|
2.5
(1.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Maslach Burnout Inventory (MBI): Depersonalization |
|---|---|
| Description | Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
1.3
(0.9)
|
1.5
(1.1)
|
||
| 3 months |
1.2
(0.8)
|
1.4
(1.0)
|
||
| 6 months |
1.3
(0.9)
|
1.5
(1.2)
|
||
| 12 months |
1.3
(1.1)
|
1.3
(0.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Maslach Burnout Inventory (MBI): Personal Accomplishment |
|---|---|
| Description | Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day). Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
4.9
(0.8)
|
4.9
(0.7)
|
||
| 3 months |
4.9
(0.7)
|
4.9
(0.7)
|
||
| 6 months |
4.9
(0.9)
|
4.9
(0.7)
|
||
| 12 months |
4.8
(0.8)
|
4.8
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Job Satisfaction |
|---|---|
| Description | Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree) Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
5.7
(1.4)
|
5.2
(1.6)
|
||
| 3 months |
5.4
(1.6)
|
5.1
(1.5)
|
||
| 6 months |
5.3
(1.7)
|
4.9
(1.7)
|
||
| 12 months |
5.6
(1.4)
|
5.2
(1.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Turnover Intentions-Considered Leaving |
|---|---|
| Description | This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, "How often have you seriously considered leaving your job in the past six months?" Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
2.0
(1.2)
|
2.6
(1.7)
|
||
| 3 months |
2.4
(1.4)
|
2.6
(1.6)
|
||
| 6 months |
2.5
(1.7)
|
2.8
(1.8)
|
||
| 12 months |
2.6
(1.5)
|
2.7
(1.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Turnover Intentions-Likely to Leave |
|---|---|
| Description | This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, "How likely are you to leave your job in the next six months?" Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
1.6
(0.8)
|
1.9
(1.0)
|
||
| 3 months |
1.8
(1.0)
|
2.0
(1.0)
|
||
| 6 months |
1.9
(1.0)
|
2.2
(1.0)
|
||
| 12 months |
1.8
(0.9)
|
2.1
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Work Interference With Home Life |
|---|---|
| Description | Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged. Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
2.7
(0.9)
|
2.9
(1.0)
|
||
| 3 months |
2.7
(0.9)
|
2.9
(1.1)
|
||
| 6 months |
2.7
(1.0)
|
2.9
(1.0)
|
||
| 12 months |
2.7
(0.8)
|
2.9
(1.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Home Life Interference With Work |
|---|---|
| Description | Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged. Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276. |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
1.9
(0.7)
|
1.9
(0.7)
|
||
| 3 months |
1.8
(0.7)
|
1.9
(0.7)
|
||
| 6 months |
1.9
(0.8)
|
1.8
(0.7)
|
||
| 12 months |
1.9
(0.7)
|
1.8
(0.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Emotional Labor Scale: Surface Acting |
|---|---|
| Description | The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
2.1
(0.8)
|
2.2
(0.8)
|
||
| 3 months |
2.2
(0.8)
|
2.3
(0.9)
|
||
| 6 months |
2.1
(0.9)
|
2.2
(1.0)
|
||
| 12 months |
2.2
(0.9)
|
2.1
(0.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Emotional Labor Scale: Deep Acting |
|---|---|
| Description | The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
3.4
(0.9)
|
3.2
(0.9)
|
||
| 3 months |
3.4
(0.7)
|
3.1
(1.0)
|
||
| 6 months |
3.1
(0.9)
|
3.2
(1.0)
|
||
| 12 months |
3.2
(0.8)
|
3.0
(1.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Emotional Labor Scale: Genuine Emotions |
|---|---|
| Description | The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
4.0
(0.8)
|
4.0
(0.6)
|
||
| 3 months |
4.1
(0.8)
|
4.0
(0.7)
|
||
| 6 months |
3.9
(0.7)
|
4.0
(0.8)
|
||
| 12 months |
4.0
(0.7)
|
4.1
(0.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Importance: Reduce Work-Related Stress |
|---|---|
| Description | Staff were asked, "How important is it for you to reduce your work-related stress right now?" This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
6.5
(3.0)
|
6.4
(2.8)
|
||
| 3 months |
6.4
(2.9)
|
7.3
(2.6)
|
||
| 6 months |
6.5
(3.0)
|
7.5
(2.6)
|
||
| 12 months |
6.6
(2.8)
|
6.6
(3.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Confidence: Reduce Work-Related Stress |
|---|---|
| Description | Staff were asked, "How confident are you that you can reduce your work-related stress in your life?" Scale: 1 (not at all confident) to 10 (extremely confident) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
7.0
(2.3)
|
6.0
(2.6)
|
||
| 3 months |
6.5
(2.6)
|
6.3
(2.5)
|
||
| 6 months |
6.6
(2.5)
|
5.7
(2.5)
|
||
| 12 months |
6.5
(2.8)
|
5.5
(2.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Importance: Client Interaction |
|---|---|
| Description | Staff were asked, "How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all important) to 10 (extremely important) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
9.4
(1.0)
|
9.5
(1.2)
|
||
| 3 months |
9.5
(0.9)
|
9.3
(1.3)
|
||
| 6 months |
9.3
(1.2)
|
9.2
(1.8)
|
||
| 12 months |
9.3
(1.2)
|
9.3
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Confidence: Client Interaction |
|---|---|
| Description | Staff were asked, "How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way?" Scale: 1 (not at all confident) to 10 (extremely confident) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
8.5
(1.5)
|
8.3
(1.7)
|
||
| 3 months |
8.5
(1.5)
|
8.1
(1.7)
|
||
| 6 months |
8.5
(1.4)
|
8.1
(1.7)
|
||
| 12 months |
8.8
(1.4)
|
8.2
(1.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care: Person Centered Care |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
3.7
(0.8)
|
3.6
(0.6)
|
||
| 3 months |
3.8
(0.6)
|
3.7
(0.6)
|
||
| 6 months |
3.8
(0.6)
|
3.8
(0.6)
|
||
| 12 months |
3.8
(0.6)
|
3.8
(0.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.21 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care: Discordant Care |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
3.8
(0.5)
|
3.8
(0.5)
|
||
| 3 months |
3.8
(0.5)
|
3.8
(0.6)
|
||
| 6 months |
3.9
(0.5)
|
3.8
(0.7)
|
||
| 12 months |
3.8
(0.6)
|
3.9
(0.5)
|
| Title | Quality of Care-Total |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
3.8
(0.5)
|
3.7
(0.5)
|
||
| 3 months |
3.8
(0.4)
|
3.7
(0.5)
|
||
| 6 months |
3.8
(0.5)
|
3.8
(0.5)
|
||
| 12 months |
3.8
(0.5)
|
3.9
(0.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Perceptions of Supervisory Support |
|---|---|
| Description | The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always) |
| Time Frame | Measured with staff at baseline, 3 months, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Baseline |
4.1
(1.1)
|
3.9
(1.0)
|
||
| 3 months |
4.0
(1.2)
|
3.9
(1.0)
|
||
| 6 months |
3.9
(1.2)
|
3.8
(1.0)
|
||
| 12 months |
4.0
(1.1)
|
4.0
(1.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Staff Turnover |
|---|---|
| Description | Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants. |
| Time Frame | Measured with staff at 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 89 | 103 | 0 | 0 |
| Separated from Agency |
23
25.8%
|
33
32%
|
||
| Not Separated from Agency |
66
74.2%
|
70
68%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Mental Health Care Staff, Motivational Interviewing-Mental Health Care Staff |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Adult State Hope Scale |
|---|---|
| Description | Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True) Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
5.78
(1.3)
|
5.78
(1.2)
|
||
| 6 months |
5.75
(1.3)
|
5.85
(1.2)
|
||
| 12 months |
5.77
(1.3)
|
5.85
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item |
|---|---|
| Description | Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes) Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients reporting they are not prescribed medications for their mental health, and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
1.9
(1.0)
|
2.0
(1.0)
|
||
| 6 months |
1.8
(1.0)
|
2.0
(1.1)
|
||
| 12 months |
1.6
(0.9)
|
1.9
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.04 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item |
|---|---|
| Description | Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes) Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients who reported they are not prescribed medications for their mental health, and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
3.0
(1.7)
|
3.3
(1.9)
|
||
| 6 months |
2.9
(1.9)
|
3.2
(2.1)
|
||
| 12 months |
2.8
(1.7)
|
3.1
(1.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Health-Care Climate Questionnaire |
|---|---|
| Description | Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree) Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
6.0
(1.2)
|
5.9
(1.1)
|
||
| 6 months |
5.8
(1.5)
|
5.9
(1.2)
|
||
| 12 months |
6.0
(1.2)
|
5.9
(1.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Working Alliance Inventory (WAI) |
|---|---|
| Description | Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
5.6
(1.2)
|
5.5
(1.2)
|
||
| 6 months |
5.4
(1.4)
|
5.6
(1.2)
|
||
| 12 months |
5.7
(1.3)
|
5.6
(1.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Working Alliance Inventory (WAI) - Tasks Subscale |
|---|---|
| Description | Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
22.0
(5.4)
|
21.5
(5.3)
|
||
| 6 months |
21.3
(6.4)
|
22.2
(5.3)
|
||
| 12 months |
22.6
(5.6)
|
22.4
(5.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Working Alliance Inventory (WAI) - Goals Subscale |
|---|---|
| Description | Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
21.8
(5.1)
|
21.4
(4.8)
|
||
| 6 months |
21.0
(5.4)
|
21.8
(4.9)
|
||
| 12 months |
22.4
(5.0)
|
21.7
(5.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Working Alliance Inventory (WAI) - Bonds Subscale |
|---|---|
| Description | Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always) Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
23.2
(5.1)
|
23.0
(5.1)
|
||
| 6 months |
22.6
(6.5)
|
23.0
(5.4)
|
||
| 12 months |
23.3
(5.5)
|
22.8
(6.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.55 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale |
|---|---|
| Description | Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
62.5
(15.6)
|
61.3
(14.8)
|
||
| 6 months |
63.6
(16.8)
|
62.1
(17.3)
|
||
| 12 months |
64.8
(15.4)
|
65.2
(16.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.91 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Short-Form Health Survey (SF-12)-Physical Health Functioning |
|---|---|
| Description | Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100). Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
41.4
(8.7)
|
41.9
(7.9)
|
||
| 6 months |
42.3
(8.3)
|
41.8
(7.8)
|
||
| 12 months |
42.0
(7.9)
|
41.7
(7.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.48 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Short-Form Health Survey (SF-12)-Mental Health Functioning |
|---|---|
| Description | Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100). Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
42.6
(7.8)
|
42.0
(8.1)
|
||
| 6 months |
42.7
(7.7)
|
43.0
(8.0)
|
||
| 12 months |
43.2
(7.2)
|
43.4
(8.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Patient Health Questionnaire 9-item (PHQ-9) |
|---|---|
| Description | The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult). Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613. American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
9.6
(5.9)
|
10.0
(6.0)
|
||
| 6 months |
8.8
(6.1)
|
9.8
(6.3)
|
||
| 12 months |
9.1
(6.0)
|
9.4
(5.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.77 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Generalized Anxiety Disorder (GAD-7) |
|---|---|
| Description | Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day) Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097. Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
9.4
(5.7)
|
9.7
(5.9)
|
||
| 6 months |
8.5
(5.7)
|
8.4
(5.6)
|
||
| 12 months |
8.5
(5.8)
|
8.8
(5.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Client Satisfaction Questionnaire |
|---|---|
| Description | Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied). |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
3.4
(0.6)
|
3.5
(0.5)
|
||
| 6 months |
3.4
(0.6)
|
3.5
(0.5)
|
||
| 12 months |
3.5
(0.5)
|
3.5
(0.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care-Person Centered Care |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
3.8
(1.1)
|
3.8
(1.0)
|
||
| 6 months |
3.7
(1.1)
|
3.8
(1.1)
|
||
| 12 months |
3.6
(1.1)
|
3.9
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care-Negative Interactions |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
4.3
(0.9)
|
4.3
(0.8)
|
||
| 6 months |
4.8
(0.8)
|
4.3
(0.9)
|
||
| 12 months |
4.3
(0.8)
|
4.4
(0.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care-Inattentive Care |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
4.2
(0.9)
|
4.2
(0.8)
|
||
| 6 months |
4.3
(0.7)
|
4.3
(0.8)
|
||
| 12 months |
4.2
(0.8)
|
4.3
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Quality of Care Total |
|---|---|
| Description | Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always) |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
4.0
(0.8)
|
4.0
(0.8)
|
||
| 6 months |
4.0
(0.8)
|
4.0
(0.8)
|
||
| 12 months |
3.9
(0.9)
|
4.1
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Patient Engagement-Missed Appointments |
|---|---|
| Description | Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period. |
| Time Frame | Measured with clients at baseline, 6 months, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each time point differs from the overall number enrolled due to missing data (medical records not available) and clients discontinuing treatment at their respective agency. |
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients |
|---|---|---|---|---|
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. |
| Measure Participants | 0 | 0 | 211 | 258 |
| Baseline |
11.96
(12.51)
|
11.02
(12.68)
|
||
| 6 months |
14.47
(15.93)
|
12.20
(14.91)
|
||
| 12 months |
14.52
(15.85)
|
11.50
(16.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BREATHE-Clients, Motivational Interviewing-Clients |
|---|---|---|
| Comments | Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not monitored or assessed for any participants in this minimal risk study. However, we did become aware of clients who had died during the study during data collection periods for follow-up interviews. The deaths were not related to the study. | |||||||
| Arm/Group Title | BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients | ||||
| Arm/Group Description | Mental Health Care Staff randomized to the BREATHE intervention Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months. | Clients linked to staff randomized to the BREATHE intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | Clients linked to staff randomized to the MI intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months. | ||||
All Cause Mortality |
||||||||
| BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/89 (0%) | 0/103 (0%) | 4/211 (1.9%) | 4/258 (1.6%) | ||||
Serious Adverse Events |
||||||||
| BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| BREATHE-Mental Health Care Staff | Motivational Interviewing-Mental Health Care Staff | BREATHE-Clients | Motivational Interviewing-Clients | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
Absence of treatment as usual condition, high staff turnover, and difficulty linking patients with specific clinicians with whom they had meaningful contact
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Michelle Salyers, PhD / Professor, Department of Psychology |
|---|---|
| Organization | Indiana University |
| Phone | 317-274-2904 |
| mpsalyer@iupui.edu |
Responsible Party:
Michelle Salyers,
Professor, Department of Psychology,
Indiana University
ClinicalTrials.gov Identifier:
NCT02146326
Other Study ID Numbers:
- IH-1304-6597
First Posted:
May 23, 2014
Last Update Posted:
Apr 14, 2017
Last Verified:
Apr 1, 2017