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The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).
Background:
Antidepressant medications and evidence-based psychotherapies are effective treatments for depression. However, antidepressant medication adherence continues to be suboptimal and offering access to and retaining patients in evidence-based psychotherapies for depression is challenging. The VHA has made major efforts to expand access to and capacity for depression focused evidence-based psychotherapies. However in 2012, only 35% of VA patients with depression completed any psychotherapy visit and only 6% completed 8 psychotherapy visits in 14 weeks, a proxy for an adequate trial.
Initiation and engagement in depression treatment may be increased if patients are offered timely access to a highly flexible, evidence-based treatment options, such as a tailored, web-based computerized cognitive-behavioral therapy (cCBT) program. cCBT has sufficient evidence for effectiveness to be a covered benefit in United Kingdom National Health Service, but has much larger effects when it is supported by clinicians or other trusted individuals. VA peer specialists, an increasing workforce in VHA mental health, are ideal candidates to support patients' engagement in depression treatment and in cCBT. Peers have been shown to promote use of Internet self-management tools, and peer specialist support for cCBT may enhance its completion and overall effectiveness through regular "check ins" and also through providing peer specific experiences, such as sharing of lived experiences and modeling of self management and recovery.
Objectives:
We are conducting a Hybrid Type I RCT of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated CBOCs. Our specific aims are to compare PS-cCBT versus enhanced usual care (EUC) on: a) patient symptomatic, functional, and recovery-oriented outcomes, b) depression coping skills, antidepressant medication adherence, and initiation and completion of more intensive traditional psychotherapy (contingent on symptom level). Our secondary aims are to assess patient, peer, and providers' experiences in PS-cCBT versus EUC using mixed methods. Finally, our exploratory aim is to assess potential mediators of improvements in depressive symptoms or functional status.
Methods:
This is a Hybrid I randomized controlled trial (RCT) of peer-supported cCBT compared to enhanced usual care (EUC) among Veterans with new diagnoses of depression in primary care. The cCBT program consists of 8 modules and will be supported by VA peer specialists with weekly contact for 12 weeks. We will assess patient symptomatic, functional and recovery-oriented outcomes at 12 and 24 week following randomization. We will also assess potential mediators of these outcomes. Bivariate and multivariate study analyses will assess the impact of the two study arms at each assessment point and over time.
Status:
Study is currently ongoing, study recruitment and follow-up is active.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS-cCBT | Experimental | peer-assisted computerized CBT |
|
| EUC | Active Comparator | Enhanced usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-assisted computerized CBT | Behavioral | Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Status | Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning. | change over time (baseline, 3 months, 6 months) |
| Depression Symptoms | Inventory of Depressive Symptoms (IDS) at baseline, 3 months post intervention and 6 months post intervention. The ISD is a 16-item self-report instrument for measuring the severity of depression among individuals. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 27. The IDS has been widely used and shows acceptable reliability, with Cronbach's of 0.86. Severity of depression is scored according to the following ranges: 1-5 (no depression), 6-10 (mild), 11-15 (moderate), 16-20 (severe), and 21-27 (very severe). | change over time (baseline, 3 months, 6 months) |
| Recovery Orientation | Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales. The scale is scored by summing all items (or scale items), with 100 being the highest possible overall score. Higher scores indicate greater sense of recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Behavioral Therapy Skills | CBT skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ). The CBTSQ is a 16-item scale consisting of two factors, Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms. Scores are summed with a maximum score of 80. Higher scores indicate greater uptake of CBT skills. |
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Inclusion Criteria:
Patients will be eligible for the study if they:
Exclusion Criteria:
Exclusion criteria for the study will include:
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| Name | Affiliation | Role |
|---|---|---|
| Paul N Pfeiffer, MD MS | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States | ||
| Battle Creek VA Medical Center, Battle Creek, MI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27148954 | Result | Abraham KM, Nelson CB, Ganoczy D, Zivin K, Brandfon S, Walters H, Cohen JL, Valenstein M. Psychometric analysis of the Mental Health Recovery Measure in a sample of veterans with depression. Psychol Serv. 2016 May;13(2):193-201. doi: 10.1037/ser0000067. | |
| 27148949 | Result | Barry CN, Abraham KM, Weaver KR, Bowersox NW. Innovating team-based outpatient mental health care in the Veterans Health Administration: Staff-perceived benefits and challenges to pilot implementation of the Behavioral Health Interdisciplinary Program (BHIP). Psychol Serv. 2016 May;13(2):148-155. doi: 10.1037/ser0000072. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care | Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips. |
| FG001 | PS-cCBT | Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Status | Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning. | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
|
Information on adverse events was collected during the duration of the participants participation in the study, which in this case, was 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care | Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips. |
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Follow-up assessment rates were lower than anticipated which may have reduced overall statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Pfeiffer | VA Center for Clinical Managment Research | 7348453649 | paul.pfeiffer@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2019 | Sep 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Enhanced usual care | Behavioral | Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips. |
|
| change over time (baseline, 3 months, 6 months) |
| Quality of Life Enjoyment and Satisfaction | The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR*D study. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). | change over time (baseline, 3 months, 6 months) |
| change over time (baseline, 3 months, 6 months) |
| Anxiety | Generalized Anxiety will be measured with the Generalized Anxiety Disorder 7-item (GAD-7). Total score ranges from 0 to 21, with "cut scores" for mild, moderate and severe anxiety. Although originally developed for generalized anxiety disorder symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder and social anxiety disorder. Scores are summed with a range of 0-21. Scores represent: 0-5 mild, 6-10 moderate, 11-15 moderate/severe, and 15-21 severe anxiety. | change over time (baseline, 3 months, 6 months) |
| Battle Creek |
| Michigan |
| 49037 |
| United States |
| John D. Dingell VA Medical Center, Detroit, MI | Detroit | Michigan | 48201 | United States |
| 31931686 | Derived | Pfeiffer PN, Pope B, Houck M, Benn-Burton W, Zivin K, Ganoczy D, Kim HM, Walters H, Emerson L, Nelson CB, Abraham KM, Valenstein M. Effectiveness of Peer-Supported Computer-Based CBT for Depression Among Veterans in Primary Care. Psychiatr Serv. 2020 Mar 1;71(3):256-262. doi: 10.1176/appi.ps.201900283. Epub 2020 Jan 14. |
| BG001 | PS-cCBT | Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| OG000 | Enhanced Usual Care | Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips. |
| OG001 | PS-cCBT | Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues |
|
|
|
| Primary | Depression Symptoms | Inventory of Depressive Symptoms (IDS) at baseline, 3 months post intervention and 6 months post intervention. The ISD is a 16-item self-report instrument for measuring the severity of depression among individuals. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 27. The IDS has been widely used and shows acceptable reliability, with Cronbach's of 0.86. Severity of depression is scored according to the following ranges: 1-5 (no depression), 6-10 (mild), 11-15 (moderate), 16-20 (severe), and 21-27 (very severe). | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
|
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|
|
| Primary | Recovery Orientation | Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales. The scale is scored by summing all items (or scale items), with 100 being the highest possible overall score. Higher scores indicate greater sense of recovery. | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
|
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|
|
| Primary | Quality of Life Enjoyment and Satisfaction | The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR*D study. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
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| Secondary | Cognitive Behavioral Therapy Skills | CBT skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ). The CBTSQ is a 16-item scale consisting of two factors, Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms. Scores are summed with a maximum score of 80. Higher scores indicate greater uptake of CBT skills. | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
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| Secondary | Anxiety | Generalized Anxiety will be measured with the Generalized Anxiety Disorder 7-item (GAD-7). Total score ranges from 0 to 21, with "cut scores" for mild, moderate and severe anxiety. Although originally developed for generalized anxiety disorder symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder and social anxiety disorder. Scores are summed with a range of 0-21. Scores represent: 0-5 mild, 6-10 moderate, 11-15 moderate/severe, and 15-21 severe anxiety. | Numbers analyzed in each time period account for attrition in follow-up | Posted | Mean | Standard Deviation | score on a scale | change over time (baseline, 3 months, 6 months) |
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| 0 |
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| 0 |
| 163 |
| 0 |
| 163 |
| EG001 | PS-cCBT | Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues | 0 | 167 | 0 | 167 | 0 | 167 |
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