Reducing Anxiety and Stress in Primary Care Patients

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03794089
Collaborator
(none)
35
1
2
33
1.1

Study Details

Study Description

Brief Summary

Anxiety is common among primary care patients, but is undertreated. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms in Veterans compared to usual care. The investigators will also examine whether Veterans like the brief treatment and whether the treatment can be feasibly delivered in primary care. Forty-eight adult Veteran primary care patients from the Syracuse VAMC who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The brief treatment consists of up to six 30-minute sessions with a cognitive-behavioral skills focus. The investigators will compare anxiety symptom severity between the two groups at baseline and at post-assessment 16 weeks later.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief anxiety intervention
  • Behavioral: Usual PC-MHI care
N/A

Detailed Description

Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of treatment are low. Primary Care-Mental Health Integration (PC-MHI), in which mental health clinicians provide brief treatment in the primary care setting, can bridge the gap between demand for, and availability of, anxiety treatment. However, brief anxiety interventions suitable for use in the PC-MHI setting are needed. Developing an effective brief PC-MHI intervention for anxiety would address a gap in VA treatment options and facilitate high quality healthcare that improves treatment engagement, clinical outcomes, and patient experience. To ensure maximum reach, this intervention should accommodate a variety of subthreshold and diagnostic anxiety presentations, as well as comorbid depression.

Objectives: The overall goal of this research program is to develop, refine, and evaluate a brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI providers. The primary aim of the current study is to conduct a pilot randomized controlled trial to evaluate feasibility, acceptability, potential implementation barriers and facilitators, and effectiveness of the intervention compared to usual care.

Methods: This will be a pilot hybrid type I effectiveness-implementation randomized controlled trial (N = 35). The primary goal is to evaluate feasibility, acceptability, and effectiveness of the intervention in reducing anxiety symptom severity compared to usual care. The secondary goal is to collect preliminary data on implementation barriers and facilitators that may affect future real-world uptake.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trial with randomization to the intervention condition or control conditionRandomized clinical trial with randomization to the intervention condition or control condition
Masking:
Single (Outcomes Assessor)
Masking Description:
Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
Primary Purpose:
Treatment
Official Title:
Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 17, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brief anxiety intervention

Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management

Behavioral: Brief anxiety intervention
Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills

Active Comparator: Usual PC-MHI care

Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care

Behavioral: Usual PC-MHI care
Anxiety treatment with mental health provider in local primary care clinic

Outcome Measures

Primary Outcome Measures

  1. Generalized Anxiety Disorder-7 at Post-Assessment [Baseline & Post-Assessment (at 16 weeks)]

    The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.

Secondary Outcome Measures

  1. Patient Health Questionnaire-9 at Post-Assessment [Baseline & Post-Assessment (at 16 weeks)]

    The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.

  2. Depression Anxiety Stress Scale-21 Anxiety Subscale Change [Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)]

    The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.

  3. Depression Anxiety Stress Scale-21 Depression Subscale Change [Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)]

    The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.

  4. Depression Anxiety Stress Scale-21 Stress Subscale Change [Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)]

    The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.

  5. Overall Anxiety Severity and Impairment Scale Change [Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)]

    Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.

  6. Overall Depression Severity and Impairment Scale Change [Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)]

    Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.

Other Outcome Measures

  1. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment [Baseline & Post-Assessment (at 16 weeks)]

    Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.

  2. Engagement in Treatment [Post-assessment (16 weeks)]

    This feasibility outcome measure is the number who attended one or more treatment sessions

  3. Number of Treatment Sessions Completed [Post-assessment (16 weeks)]

    This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase

  4. Treatment Satisfaction [Post-assessment (at 16 weeks)]

    The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.

  5. Treatment Credibility [Post-assessment (16 weeks)]

    The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.

  6. Therapeutic Alliance [Post-assessment (16 weeks)]

    The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18 years or older

  • Veteran seen in the Syracuse VA Medical Center primary care clinic in the past year

  • Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (8 on Generalized Anxiety Disorder-7)

Exclusion Criteria:
  • Inability to communicate in English (as assessed by study staff)

  • Report or demonstrate hearing impairment that would preclude telephone screening (as assessed by study staff)

  • Inability to demonstrate informed consent

  • defined as not being able to comprehend the study description as assessed by study staff and/or not being able to answer the comprehension of consent questions

  • have a diagnosis of dementia or severe cognitive impairment (defined by primary care provider or self-report, or having a diagnosis in Problem List)

  • screen positive for cognitive impairment (3 or more errors on cognitive screener)

  • Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness (SMI) in Problem List

  • i.e., psychotic disorders, bipolar disorder

  • Have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2 years OR screen positive for PTSD (3 or more on PC-PTSD-5)

  • Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of the following within the past 30 days:

  • attending specialty mental health sessions [excluding a single intake session]

  • attending 2 or more Primary Care-Mental Health Integration sessions

  • Being hospitalized for mental health treatment

  • Report severe depressive symptoms (20 or more on Patient Health Questionnaire-9)

  • At imminent risk of suicide

  • defined as being identified as imminent risk based on study staff's suicide risk assessment [verified by the PI] and in need of intensive treatment

  • e.g., hospitalization] to ensure safety

  • Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days

Contacts and Locations

Locations

Site City State Country Postal Code
1 Syracuse VA Medical Center, Syracuse, NY Syracuse New York United States 13210

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Robyn L. Shepardson, PhD, Syracuse VA Medical Center, Syracuse, NY

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03794089
Other Study ID Numbers:
  • CDX 18-006
First Posted:
Jan 4, 2019
Last Update Posted:
Jul 12, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Participants were adult (age 18 years or older) Veterans recruited from primary care clinics at the Syracuse VA Medical Center from April 2019 through October 2020. Eligible participants were identified through case finding from electronic medical records, direct referrals from primary care and behavioral health providers, or referrals from other local behavioral health research studies.
Pre-assignment Detail A telephone eligibility screening identified those eligible to participate in the study, based on study eligibility criteria including endorsing current anxiety anxiety symptoms and not already being in psychotherapy for anxiety/depression.
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Period Title: Overall Study
STARTED 17 18
Completed 4-week Assessment 16 18
Completed 8-week Assessment 14 18
Completed 12-week Assessment 13 17
COMPLETED 11 17
NOT COMPLETED 6 1

Baseline Characteristics

Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care Total
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic Total of all reporting groups
Overall Participants 17 18 35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
49.29
(15.76)
45.56
(16.88)
47.37
(16.21)
Sex: Female, Male (Count of Participants)
Female
2
11.8%
3
16.7%
5
14.3%
Male
15
88.2%
15
83.3%
30
85.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
11.8%
2
11.1%
4
11.4%
Not Hispanic or Latino
15
88.2%
16
88.9%
31
88.6%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
5.6%
1
2.9%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
3
17.6%
0
0%
3
8.6%
White
11
64.7%
16
88.9%
27
77.1%
More than one race
0
0%
1
5.6%
1
2.9%
Unknown or Not Reported
3
17.6%
0
0%
3
8.6%
Generalized Anxiety Disorder-7 (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
12.76
(4.41)
11.94
(3.00)
12.34
(3.72)
Patient Health Questionnaire-9 (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
11.18
(4.54)
10.78
(5.08)
10.97
(4.76)

Outcome Measures

1. Primary Outcome
Title Generalized Anxiety Disorder-7 at Post-Assessment
Description The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.
Time Frame Baseline & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed Post-Assessment at 16 weeks
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 11 17
GAD-7 total at Baseline
12.5
(4.2)
12.0
(3.1)
GAD-7 total at Post (16 weeks)
4.6
(5.2)
9.1
(5.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments comparisons of groups at post-assessment controls for baseline GAD-7 total scores
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.035
Comments a priori threshold for statistical significance was p<=.05
Method ANCOVA
Comments
2. Secondary Outcome
Title Patient Health Questionnaire-9 at Post-Assessment
Description The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.
Time Frame Baseline & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled Participants who completed Post-Assessment at 16 weeks
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 11 17
PHQ-9 total at Baseline
10.5
(5.0)
10.8
(5.2)
PHQ-9 total at Post (16 weeks)
5.1
(4.7)
7.6
(6.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments comparisons of groups at post-assessment controls for baseline PHQ-9 total scores
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.231
Comments a priori threshold for statistical significance was p<=0.05
Method ANCOVA
Comments
3. Secondary Outcome
Title Depression Anxiety Stress Scale-21 Anxiety Subscale Change
Description The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed each assessment
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
DASS-21 Anxiety subscale total at Baseline
12.4
(9.4)
10.1
(9.5)
DASS-21 Anxiety subscale total at 4 weeks
10.4
(7.3)
9.4
(8.3)
DASS-21 Anxiety subscale total at 8 weeks
7.0
(6.3)
10.1
(8.6)
DASS-21 Anxiety subscale total at 12 weeks
4.8
(4.7)
9.9
(7.4)
DASS-21 Anxiety subscale total at Post Assessment (16 weeks)
4.9
(5.0)
9.6
(7.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.393
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.022
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.013
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.049
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
4. Secondary Outcome
Title Depression Anxiety Stress Scale-21 Depression Subscale Change
Description The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.
Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed each assessment
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
DASS-21 Depression subscale total at Baseline
15.6
(9.9)
12.2
(9.5)
DASS-21 Depression subscale total at 4 weeks
8.1
(5.6)
11.1
(11.2)
DASS-21 Depression subscale total at 8 weeks
6.0
(4.8)
11.9
(9.6)
DASS-21 Depression subscale total at 12 weeks
4.5
(4.3)
10.8
(10.8)
DASS-21 Depression subscale total at Post-assessment (16 weeks)
4.9
(4.9)
9.9
(12.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Depression subscale total from Baseline to 4 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.008
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Depression subscale total from Baseline to 8 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value <0.001
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Depression subscale total from Baseline to 12 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value <0.001
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.008
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
5. Secondary Outcome
Title Depression Anxiety Stress Scale-21 Stress Subscale Change
Description The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed each assessment
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
DASS-21 Stress subscale total at Baseline
18.7
(8.6)
17.8
(6.9)
DASS-21 Stress subscale total at 4 weeks
16.9
(8.0)
17.3
(11.2)
DASS-21 Stress subscale total at 8 weeks
11.7
(6.9)
17.0
(10.4)
DASS-21 Stress subscale total at 12 weeks
10.5
(8.0)
16.4
(11.0)
DASS-21 Stress subscale total at Post-assessment (16 weeks)
7.6
(9.2)
14.1
(10.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Stress subscale total from Baseline to 4 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.440
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Stress subscale total from Baseline to 8 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.022
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Stress subscale total from Baseline to 12 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.032
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.091
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
6. Secondary Outcome
Title Overall Anxiety Severity and Impairment Scale Change
Description Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.
Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed each assessment
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
OASIS total at Baseline
9.4
(3.9)
9.4
(2.8)
OASIS total at 4 weeks
6.2
(3.3)
8.2
(3.8)
OASIS total at 8 weeks
5.5
(3.4)
8.0
(4.6)
OASIS total at 12 weeks
4.8
(3.7)
8.2
(4.0)
OASIS total at Post-assessment (16 weeks)
4.1
(3.8)
7.4
(3.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in OASIS total score from Baseline to 4 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.058
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in OASIS total score from Baseline to 8 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.032
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in OASIS total score from Baseline to 12 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.007
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in OASIS total score from Baseline to Post assessment (16 weeks)
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.044
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
7. Secondary Outcome
Title Overall Depression Severity and Impairment Scale Change
Description Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.
Time Frame Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled participants who completed each assessment
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
ODSIS total at Baseline
6.5
(4.3)
6.2
(4.5)
ODSIS total at 4 weeks
4.3
(3.7)
5.3
(4.4)
ODSIS total at 8 weeks
3.9
(3.5)
5.6
(5.5)
ODSIS total at 12 weeks
2.7
(3.3)
6.2
(5.3)
ODSIS total at Post-assessment (16 weeks)
3.0
(3.7)
5.0
(4.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in ODSIS total from Baseline to 4 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.328
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in ODSIS total from Baseline to 8 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.148
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in ODSIS total from Baseline to 12 weeks
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.002
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Change in ODSIS total from Baseline to Post-assessment (16 weeks)
Type of Statistical Test Superiority
Comments Testing null hypothesis of no difference between groups
Statistical Test of Hypothesis p-Value 0.069
Comments a priori threshold for statistical significance was p<=0.05
Method Mixed Models Analysis
Comments
8. Other Pre-specified Outcome
Title Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment
Description Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.
Time Frame Baseline & Post-Assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
Enrolled Participants who completed Post-Assessment at 16 weeks
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 11 17
Q-LES-Q-SF total at Baseline
44.9
(8.5)
43.8
(7.4)
Q-LES-Q-SF total at Post (16 weeks)
49.9
(8.1)
48.7
(10.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.928
Comments a priori threshold for statistical significance was p<=0.05
Method ANCOVA
Comments
9. Other Pre-specified Outcome
Title Engagement in Treatment
Description This feasibility outcome measure is the number who attended one or more treatment sessions
Time Frame Post-assessment (16 weeks)

Outcome Measure Data

Analysis Population Description
All participants who enrolled in the study
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
Number [participants]
15
88.2%
13
72.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Testing null hypothesis of no difference between groups
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.402
Comments a priori threshold for statistical significance was p<.05
Method Fisher Exact
Comments degrees of freedom = 1
10. Other Pre-specified Outcome
Title Number of Treatment Sessions Completed
Description This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase
Time Frame Post-assessment (16 weeks)

Outcome Measure Data

Analysis Population Description
All participants enrolled in the study
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 17 18
Mean (Standard Deviation) [sessions]
4.7
(2.2)
1.8
(1.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Testing the null hypothesis of no difference between groups
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments a priori threshold for statistical significance was p<=.05
Method t-test, 2 sided
Comments
11. Other Pre-specified Outcome
Title Treatment Satisfaction
Description The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.
Time Frame Post-assessment (at 16 weeks)

Outcome Measure Data

Analysis Population Description
All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 10 13
Mean (Standard Deviation) [score on a scale]
29.80
(2.82)
24.23
(5.69)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Testing the null hypothesis of no difference between groups
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .006
Comments a priori threshold for statistical significance was p<=.05
Method t-test, 2 sided
Comments Used Satterthwaite method given unequal variances
12. Other Pre-specified Outcome
Title Treatment Credibility
Description The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.
Time Frame Post-assessment (16 weeks)

Outcome Measure Data

Analysis Population Description
All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 10 13
Mean (Standard Deviation) [score on a scale]
34.20
(5.51)
22.31
(11.49)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Testing the null hypothesis of no difference between groups
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments a priori threshold for statistical significance was p<=.05
Method t-test, 2 sided
Comments used Satterthwaite method given unequal variances
13. Other Pre-specified Outcome
Title Therapeutic Alliance
Description The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.
Time Frame Post-assessment (16 weeks)

Outcome Measure Data

Analysis Population Description
All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
Measure Participants 10 13
Mean (Standard Deviation) [score on a scale]
55.00
(5.54)
42.62
(9.73)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Anxiety Intervention, Usual PC-MHI Care
Comments Testing the null hypothesis of no difference between groups
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments a priori threshold for statistical significance was p<=.05
Method t-test, 2 sided
Comments

Adverse Events

Time Frame Adverse event data were collected over the course of a participant's study participation, 16 weeks.
Adverse Event Reporting Description n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
Arm/Group Title Brief Anxiety Intervention Usual PC-MHI Care
Arm/Group Description Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
All Cause Mortality
Brief Anxiety Intervention Usual PC-MHI Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/17 (0%) 0/18 (0%)
Serious Adverse Events
Brief Anxiety Intervention Usual PC-MHI Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/17 (0%) 1/18 (5.6%)
Cardiac disorders
Hospitalization 0/17 (0%) 0 1/18 (5.6%) 1
Other (Not Including Serious) Adverse Events
Brief Anxiety Intervention Usual PC-MHI Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/17 (5.9%) 0/18 (0%)
Social circumstances
Symptom exacerbation 1/17 (5.9%) 1 0/18 (0%) 0

Limitations/Caveats

This was a single-site pilot trial with a small sample size so results should be interpreted with caution. The attrition rate for assessments was slightly higher in the intervention (vs. comparison) condition. However, multi-level modeling analyses made use of all participant data provided. We did not have a follow-up assessment to examine whether treatment gains were maintained over time.

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.

Results Point of Contact

Name/Title Dr. Robyn L. Shepardson
Organization VA Center for Integrated Healthcare
Phone 315-425-4400 ext 53956
Email Robyn.Shepardson@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03794089
Other Study ID Numbers:
  • CDX 18-006
First Posted:
Jan 4, 2019
Last Update Posted:
Jul 12, 2022
Last Verified:
Mar 1, 2022