Evaluation of a Mental Health Physician Support Program in Nova Scotia

• Sponsor: Nova Scotia Health Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT01975948
• Collaborator: (none)
• Enrollment: 285
• Location: 1
• Arms: 4
• Actual Duration (Months): 25
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

The aim of this study is to test the program's effectiveness in a primary care setting in reducing stigma among medical personnel, increasing the comfort level of physicians and staff in providing care to those living with mental illness, and in improving client well-being and mental health.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Other: Mental Health Practice Support Program; Other: Treatment as Usual	N/A

Detailed Description

Skill-based approaches are effective in reducing stigma in health professionals.

Overview: The Nova Scotia (NS) Department of Health and Wellness and the Mental Health Commission of Canada launched a demonstration project in NS-Adult Mental Health Practice Support Program. Originating in British Columbia (BC), it uses a novel learning platform which supports primary healthcare providers with treatment and management of mental illness. We hypothesized that enhanced skills in program participants would lead to increased comfort on the part of practitioners, diminished social distance and stigmatization; improved clinical outcomes and a reduction in healthcare costs.

This evaluation has three co-primary objectives:

• To determine whether the Mental Health Practice Support Program (PSP) leads to lower levels of stigma among physicians participating in the program.

• To determine whether participation in the Mental Health PSP leads to lower levels of stigma among medical office assistants (MOAs)

• To determine whether participation of physicians in the Mental Health PSP leads to greater improvement in depressive symptom ratings among patients they are treating for depression, compared to treatment as usual.

Two secondary objectives:

• To determine whether participation in the PSP leads to improved occupational functioning compared to treatment as usual.

• To assess the impact of participation in the Mental Health PSP on healthcare costs.

Four exploratory objectives:

• To assess physicians' confidence and comfort in the management of depression treatment

• To determine whether physician participation int he Mental Health PSP is associated with a reduced frequency of antidepressant prescribing.

• To determine whether the patients of physicians participating in the Mental Health PSP report higher levels of satisfaction with the treatment that they receive.

• To determine whether patients participation in the Mental Health PSP is associated with improved quality of life.

Methods: Seventy seven practices with one hundred and eleven community-based family physicians were recruited. Each practice was assigned a practice number. Each physician within the practice was assigned a unique identifier number. Individual practitioner or practice teams were randomly assigned to intervention or control groups. Randomization was stratified on the total number of physicians per practice, as well as urban or rural setting to ensure equal distribution of practice clusters and urban and rural groups. STATA, version 12 [College Station, TX, 2012] to generate the sequence for practice [cluster] randomization. Random numbers were generated from a binomial distribution with a probability of success of 0.5. Intervention group participants attended 3 half-day workshops with a "6- week action period" between workshops to practice learnings. Practice support was provided through diagnostic assessment tools, evidence based self-management tools, and on-site practice support coordinator support. A stigma-assessment tool, the Opening Minds Scale for Healthcare Providers (OMS-HC), was administered to both groups at intervention group pre-training, and post-training. Providers comfort and confidence in diagnosing and managing mental illness was also assessed, at comparable times.

Upon completion of the intervention group training, physicians from both groups were asked to identify 3 consecutive evaluable patients. Patients were enrolled and allocated to intervention or control groups as per their associated physician.

Study Design

• Study Type: Interventional
• Actual Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization
• Actual Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mental Health PSP: Physicians Physicians training in Adult Mental Health Practice Support Program	Other: Mental Health Practice Support Program; training and (2) practice support. Three half day workshop sessions over a 24 week period. Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes
Active Comparator: Treatment as Usual: Physicians Those administering treatment as usual for depression	Other: Treatment as Usual; Physicians manage patients with depression as usual
Experimental: Mental Health PSP: Patients Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Other: Mental Health Practice Support Program; training and (2) practice support. Three half day workshop sessions over a 24 week period. Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes
Active Comparator: Treatment as Usual: Patients Those receiving treatment as usual for depression	Other: Treatment as Usual; Physicians manage patients with depression as usual

Outcome Measures

Primary Outcome Measures

1. Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline [Baseline, 1, 2, 3, and 6 months]

   The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.

2. Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) [Baseline and at 6 months]

   The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.

Secondary Outcome Measures

1. Between Group Changes in Occupational Functioning From Baseline to 6 Months [Baseline, 1, 2, 3, and 6 months]

   Lam's Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.

Other Outcome Measures

1. Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness [Baseline and 6 months]

   A modified version of a British Columbia (BC) developed survey, "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to: diagnose depression screen for addictions screen for other mental health conditions treat depression treat other mental health disorders prescribe medications for mental health conditions assess patients' problems and strengths overall confidence in quality of mental health care provided knowledge/awareness of non-pharmaceutical interventions knowledge/awareness of regional mental health resources for patients Cronbach's alpha .84 at pre-test and .87 at post-test

2. Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills [Baseline and 6 months]

   A modified version of a British Columbia (BC) developed survey "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test, 3

3. Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills [Baseline and 6 months]

   A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test

4. Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months [Baseline, 1, 2,3, and 6 months]

   The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal CSI ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.

5. Between Groups Changes in Quality of Life From Baseline to 6 Months. [Baseline, 1, 2, 3 and 6 months]

   The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SF-36 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.

6. Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months [6 months]

   We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.

7. Between Group Change in Sheehan Disability Scale (SDS) [Baseline, 1, 2, 3, and 6 months]

   The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SDS ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Physician sample:

• A valid license to practice in Nova Scotia.

• The provision of informed consent.

Patient sample:

Inclusion Criteria:

• Depression defined by PHQ-9 score of > 10.

• 18 years old.

• Able to read and speak English.

• Sufficiently intact cognitive functioning (physician judgement).

• Free of urgent or emergent medical or psychiatric issues e.g. unstable cardiovascular disease, suicidal ideation.

Exclusion Criteria:

• Not currently under treatment for depression either with an antidepressant medication or psychotherapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dalhousie University Department of Psychiatry	Halifax	Nova Scotia	Canada	B3H2E2

Sponsors and Collaborators

• Nova Scotia Health Authority

Investigators

• Principal Investigator: Bianca A Lauria-Horner, MD, Associate Professor Dalhousie University Department of Psychiatry
• Principal Investigator: Scott Patten, FRCP(C), PhD, Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bianca Horner, Primary Mental Healthcare Education Leader, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT01975948
• Other Study ID Numbers: CDHA-RS/2014-150
• First Posted: Nov 5, 2013
• Last Update Posted: Oct 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Bianca Horner, Primary Mental Healthcare Education Leader, Nova Scotia Health Authority: Mental Health; Education and Practice Support Program; Depression; Primary Care; Skill-based training; Patient centered outcomes
• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major

Study Results

Participant Flow

Recruitment Details	Seventy seven practices with one hundred and eleven community-based family physicians were recruited between September 2013 and January 2014.
Pre-assignment Detail	285 participants were enrolled in the study: Physicians (n=111);Patients (n=129); Medical office Staff (MOAs) (n=45) MOA Group: MOAs excluded from outcome analysis due to inconsistent particpation and small sample size

Arm/Group Title	Mental Health Practice Support Program;Physician Sample	Depression Treatment as Usual;Physician Sample	Mental Health Practice Support Program;Patient Sample	Treatment as Usual: Patient Sample
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual	Patients were assigned to the same arm as their physician who were randomized to the Practice Support Program training. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015	Patients were assigned to the same arm as their physician, who were randomized to treating their patients as usual. Patients were enrolled between June 2014-May 2015 with the last follow-up visit in November 2015
Period Title: Overall Study
STARTED	56	55	72	57
COMPLETED	39	34	65	51
NOT COMPLETED	17	21	7	6

Baseline Characteristics

Arm/Group Title	Practice Support Program: Physician Sample	Treatment as Usual: Physician Sample	Practice Support Program: Patient Sample	Treatment as Usual: Patient Sample	Total
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual	Patients of physicians trained in the Adult Mental Health Practice Support Program. Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician.	Patients of physician who were randomized in the control group (TAU). Inclusion criteria included >18 years of age, with a diagnosis of depression, PHQ-9 score of > 10, able to read and speak in English at grade 6 level, and intact cognitive functioning (physician judgment). Exclusion criteria included active treatment with antidepressants within 5 weeks and psychotherapy within 3 months of enrollment, and clinically judged urgent or emergent medical/psychiatric condition by their physician.	Total of all reporting groups
Overall Participants	39	34	65	51	189
Age, Customized (participants) [Number]
Physician 20-29years	0 0%	2 5.9%	NA NaN	NA NaN	NA NaN
Physician 30-39years	8 20.5%	5 14.7%	NA NaN	NA NaN	NA NaN
Physician 40-49years	10 25.6%	14 41.2%	NA NaN	NA NaN	NA NaN
Physician 50-59years	16 41%	10 29.4%	NA NaN	NA NaN	NA NaN
Physician 60-69years	5 12.8%	3 8.8%	NA NaN	NA NaN	NA NaN
Age, Customized (Count of Participants)
Patients 18-29 years	NA NaN	NA NaN	11 16.9%	12 23.5%	NA NaN
Patients 30-39 years	NA NaN	NA NaN	13 20%	18 35.3%	NA NaN
Patients 40-49 years	NA NaN	NA NaN	14 21.5%	8 15.7%	NA NaN
Patients 50-59 years	NA NaN	NA NaN	9 13.8%	7 13.7%	NA NaN
Patients 60-69 years	NA NaN	NA NaN	9 13.8%	3 5.9%	NA NaN
Patients >70 years	NA NaN	NA NaN	5 7.7%	1 2%	NA NaN
Sex: Female, Male (Count of Participants)
Female	21 53.8%	21 61.8%	45 69.2%	40 78.4%	127 67.2%
Male	18 46.2%	13 38.2%	20 30.8%	11 21.6%	62 32.8%
Region of Enrollment (participants) [Number]
Canada	39 100%	34 100%	65 100%	51 100%	189 100%
Years in practice (participants) [Number]
Less than 1 year	0 0%	2 5.9%	NA NaN	NA NaN	NA NaN
1-4years	7 17.9%	2 5.9%	NA NaN	NA NaN	NA NaN
5-9years	3 7.7%	3 8.8%	NA NaN	NA NaN	NA NaN
10-14years	3 7.7%	5 14.7%	NA NaN	NA NaN	NA NaN
15-19years	1 2.6%	6 17.6%	NA NaN	NA NaN	NA NaN
20-24years	9 23.1%	3 8.8%	NA NaN	NA NaN	NA NaN
25-29years	9 23.1%	7 20.6%	NA NaN	NA NaN	NA NaN
30 years or more	5 12.8%	6 17.6%	NA NaN	NA NaN	NA NaN
Pattern of work (participants) [Number]
Full time	34 87.2%	29 85.3%	NA NaN	NA NaN	NA NaN
Part time	5 12.8%	5 14.7%	NA NaN	NA NaN	NA NaN
Practice type (participants) [Number]
Solo practice	9 23.1%	5 14.7%	NA NaN	NA NaN	NA NaN
2-physician practice	8 20.5%	5 14.7%	NA NaN	NA NaN	NA NaN
Small gp practice (<5)	16 41%	8 23.5%	NA NaN	NA NaN	NA NaN
Large gp practice (5+)	5 12.8%	16 47.1%	NA NaN	NA NaN	NA NaN
Unique patients/yr (participants) [Number]
Fewer than 1,000	6 15.4%	7 20.6%	NA NaN	NA NaN	NA NaN
1,000-1,999	12 30.8%	12 35.3%	NA NaN	NA NaN	NA NaN
2,000-2,999	2 5.1%	7 20.6%	NA NaN	NA NaN	NA NaN
3,000 or more	11 28.2%	6 17.6%	NA NaN	NA NaN	NA NaN
Other (hospitalist, locum, etc)	2 5.1%	0 0%	NA NaN	NA NaN	NA NaN
Marital Status (Count of Participants)
Patients: Married/common-law	NA NaN	NA NaN	33 50.8%	32 62.7%	NA NaN
Patients: Separated/divorced	NA NaN	NA NaN	11 16.9%	5 9.8%	NA NaN
Patients: Never married	NA NaN	NA NaN	17 26.2%	10 19.6%	NA NaN
Patients: Widowed	NA NaN	NA NaN	0 0%	2 3.9%	NA NaN
Employment status (Count of Participants)
Patients: Employed full time	NA NaN	NA NaN	27 41.5%	26 51%	NA NaN
Patients:Employed part time	NA NaN	NA NaN	8 12.3%	13 25.5%	NA NaN
Patients:Unemployed but available to work	NA NaN	NA NaN	5 7.7%	2 3.9%	NA NaN
Patients:Unemployed due to illness	NA NaN	NA NaN	6 9.2%	3 5.9%	NA NaN
Patients:Retired/student/at-home/other	NA NaN	NA NaN	5 7.7%	15 29.4%	NA NaN
Education (Count of Participants)
Some elementary or high school	NA NaN	NA NaN	8 12.3%	2 3.9%	NA NaN
High school diploma	NA NaN	NA NaN	14 21.5%	6 11.8%	NA NaN
Some post-secondary	NA NaN	NA NaN	5 7.7%	10 19.6%	NA NaN
Post-secondary certificate/diploma	NA NaN	NA NaN	14 21.5%	17 33.3%	NA NaN
Post-secondary degree	NA NaN	NA NaN	15 23.1%	13 25.5%	NA NaN
Master's degree or higher	NA NaN	NA NaN	5 7.7%	1 2%	NA NaN
Mother tongue (Count of Participants)
Patient: English	NA NaN	NA NaN	56 86.2%	48 94.1%	NA NaN
Patient: French	NA NaN	NA NaN	3 4.6%	0 0%	NA NaN
Patient: Other	NA NaN	NA NaN	2 3.1%	1 2%	NA NaN
Who do you usually live with? (Count of Participants)
Patient: Husband/wife/steady partner	NA NaN	NA NaN	18 27.7%	17 33.3%	NA NaN
Patient:Spouse partner and children	NA NaN	NA NaN	15 23.1%	19 37.3%	NA NaN
Patient:Children (but no spouse/partner)	NA NaN	NA NaN	4 6.2%	2 3.9%	NA NaN
Patient:Parents	NA NaN	NA NaN	4 6.2%	4 7.8%	NA NaN
Patient:Alone	NA NaN	NA NaN	13 20%	6 11.8%	NA NaN
Patient:Other	NA NaN	NA NaN	6 9.2%	1 2%	NA NaN

Outcome Measures

1. Primary Outcome

Title	Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
Description	The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Time Frame	Baseline, 1, 2, 3, and 6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
baseline	16.43 (4.77)	17.28 (4.12)
1 month	11.25 (5.82)	10.39 (6.49)
2 months	9.72 (6.28)	8.46 (6.47)
3 months	8.44 (6.15)	7.55 (6.13)
6 month	6.78 (5.41)	8.42 (6.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.047
	Comments	Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)
Description	The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.
Time Frame	Baseline and at 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Depression Treatment as Usual: Physicians manage patients with depression as usual
Measure Participants	39	34
OMS-HC Total Score Baseline	2.21 (.40)	2.11 (.35)
OMS-HC Total Score 6 months	2.07 (.46)	2.07 (.38)
Attitudes subscale:Baseline	2.13 (.48)	2.02 (.48)
Attitudes subscale: 6 months	1.97 (.49)	1.9 (.51)
Disclosure/help-seeking: Baselinr	2.65 (.66)	2.65 (.61)
Disclosure/help-seeking: 6 months	2.57 (.75)	2.63 (.52)
Social distance: Baseline	1.95 (.46)	1.77 (.39)
Social distance : 6 months	1.79 (.55)	1.82 (.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	Our calculations indicated that 50 physicians in each of the two groups will provide >80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments	OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	.45
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Between Group Changes in Occupational Functioning From Baseline to 6 Months
Description	Lam's Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Time Frame	Baseline, 1, 2, 3, and 6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
Baseline	11.26 (5.80)	12.76 (6.52)
1 month	7.67 (5.36)	7.13 (5.96)
2 months	7.45 (6.21)	7.16 (6.88)
3 months	5.54 (4.37)	5.96 (5.06)
6 months	6.04 (5.79)	6.03 (6.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.993
	Comments
	Method	Mixed Models Analysis
	Comments

4. Other Pre-specified Outcome

Title	Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness
Description	A modified version of a British Columbia (BC) developed survey, "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to: diagnose depression screen for addictions screen for other mental health conditions treat depression treat other mental health disorders prescribe medications for mental health conditions assess patients' problems and strengths overall confidence in quality of mental health care provided knowledge/awareness of non-pharmaceutical interventions knowledge/awareness of regional mental health resources for patients Cronbach's alpha .84 at pre-test and .87 at post-test
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Practice Support Program: Physician Sample	Treatment as Usual: Physician Sample
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Treatment as Usual for Depression Depression Treatment as Usual: Physicians manage patients with depression as usual
Measure Participants	39	34
Baseline Management of mental illness	2.18 (.39)	2.03 (.37)
6 monthsManagement of mental illness	1.80 (.36)	2.12 (.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	1.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	Generalized estimating equations (GEE)
	Comments	We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.

5. Other Pre-specified Outcome

Title	Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills
Description	A modified version of a British Columbia (BC) developed survey "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test, 3
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Depression Treatment as Usual: Physicians manage patients with depression as usual
Measure Participants	39	34
Baseline non-program specific mental health tools	2.34 (.4)	2.27 (.5)
6 months non-program specific mental health tools	1.81 (.4)	2.32 (.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	1.44
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.476
	Comments	We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.
	Method	Generalized estimating equations (GEE)
	Comments

6. Other Pre-specified Outcome

Title	Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills
Description	A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mental Health PSP: Physicians	Treatment as Usual: Physicians
Arm/Group Description	Physician training in Adult Mental Health Practice Support Program Mental Health Practice Support Program: (1) training and (2) practice support. •Three half day workshop sessions over a 24 week period. •Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes	Depression Treatment as Usual: Physicians manage patients with depression as usual
Measure Participants	39	34
Baseline program specific mental health tools	2.82 (.31)	2.80 (.20)
6 months program specific mental health tools	1.79 (.44)	2.64 (.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Cohen'd
	Estimated Value	3.25
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments	Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.945
	Comments	We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.
	Method	Generalized estimating equations (GEE)
	Comments

7. Other Pre-specified Outcome

Title	Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months
Description	The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal CSI ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Time Frame	Baseline, 1, 2,3, and 6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
Baseline	6.3 (.51)	6.1 (.87)
I month	6.1 (.79)	6.1 (.95)
2 months	6.2 (.76)	6.2 (.95)
3 months	6.1 (.93)	6.1 (.91)
6 months	6.1 (.79)	6.0 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.742
	Comments
	Method	Mixed Models Analysis
	Comments

8. Other Pre-specified Outcome

Title	Between Groups Changes in Quality of Life From Baseline to 6 Months.
Description	The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SF-36 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Time Frame	Baseline, 1, 2, 3 and 6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
Baseline	54.03 (14.07)	54.10 (12.92)
1 month	57.73 (17.09)	62.33 (15.30)
2 months	61.77 (18.38)	67.62 (15.59)
3 months	62.45 (21.76)	66.99 (18.83)
6 months	67.09 (20.88)	69.03 (21.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.543
	Comments
	Method	Mixed Models Analysis
	Comments

9. Other Pre-specified Outcome

Title	Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months
Description	We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
Count of Participants [Participants]	31 79.5%	35 102.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.009
	Comments
	Method	Mixed Models Analysis
	Comments

10. Other Pre-specified Outcome

Title	Between Group Change in Sheehan Disability Scale (SDS)
Description	The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SDS ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.
Time Frame	Baseline, 1, 2, 3, and 6 months

Outcome Measure Data

Analysis Population Description

All participants with at least one follow-up data (n=116) were included in the analysis

Arm/Group Title	Mental Health PSP: Patients	Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.	Those receiving treatment as usual for depression.
Measure Participants	65	51
Baseline	18.87 (7.06)	19.83 (6.20)
1 month	13.87 (8.19)	13.03 (8.99)
2 months	13.74 (9.12)	9.43 (8.95)
3 months	10.42 (9.34)	8.28 (7.29)
6 months	7.64 (7.27)	7.86 (8.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mental Health PSP: Patients, Treatment as Usual: Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.213
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Adverse Event Reporting Description	Serious and other adverse events were not monitored/assessed. The clinical skills and knowledge addressed in the training are standard approaches, involving cognitive and behavioral strategies. There are no risks associated with the implementation of these strategies.
Arm/Group Title	Mental Health PSP: Patients		Treatment as Usual: Patients
Arm/Group Description	Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.		Those receiving treatment as usual for depression.
All Cause Mortality
	Mental Health PSP: Patients		Treatment as Usual: Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mental Health PSP: Patients		Treatment as Usual: Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Mental Health PSP: Patients		Treatment as Usual: Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Challenges in physician sample: 75% completed pre-post OMS-HC scale Physicians experienced challenges identifying study patients leading to small number of patients.

More Information

Certain Agreements

Principal Investigators are NOT 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.