Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
|ClinicalTrials.gov Identifier: NCT02057042|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Peer-assisted computerized CBT Behavioral: Enhanced usual care||Not Applicable|
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.
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.
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.
Study is currently ongoing, study recruitment and follow-up is active.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression|
|Actual Study Start Date :||June 1, 2015|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
peer-assisted computerized CBT
Behavioral: 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
Active Comparator: EUC
Enhanced usual care
Behavioral: 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.
- functional status [ Time Frame: change over time (baseline, 3 months, 6 months) ]Functional status will be measured using the Veterans RAND 36-Item Health Survey (VR-36), formerly called the Short-Form 36 for Veterans. This is a measure of functional status adapted from the Medical Outcomes Study Short Form-36 for use among Veterans. The measure assesses physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health perceptions (GH), energy/vitality (V), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The VR-36 has somewhat greater precision at the lower end of the health status continuum than the SF-36. The VR-36 has been used in numerous prior VA focused studies.
- depression symptoms [ Time Frame: change over time (baseline, 3 months, 6 months) ]Depressive symptoms will be measured with the Beck Depression Inventory (BDI-II) at baseline, 3 months post intervention and 6 months post intervention. The BDI-II is a 21-item self-report instrument for measuring the severity of depression among individuals aged 13 years and older. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 63. The BDI has been widely used and shows acceptable reliability, with Cronbach's in the range of 0.81-0.86.
- recovery orientation [ Time Frame: change over time (baseline, 3 months, 6 months) ]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.
- Quality of Life [ Time Frame: change over time (baseline, 3 months, 6 months) ]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.
- depression coping [ Time Frame: change over time (baseline, 3 months, 6 months) ]Depression coping will be assessed with the Depression Coping Self-Efficacy Scale (DCSES). The DCSES is a 24-item, self-report rating scale used to assess the coping self-efficacy of psychiatric patients with depression. Items include depression management tasks and techniques related to activity level, tension, interpersonal behavior, problem-solving, thought reformulation, and sleep patterns. Individuals respond to each item using a probability scale, in which they numerically rate their confidence in their abilities to perform each task. This measure has demonstrated to have good reliability, with a Cronbach's of .93, and subsequent studies have provided support for the construct, concurrent, and discriminant validities of the DCSES.
- antidepressant adherence [ Time Frame: change over time (baseline, 3 months, 6 months) ]We will construct medication possession ratios for antidepressants prescribed for the 3 months following enrollment and for 3-6 months following enrollment. In addition to pharmacy data, The Brief Medication Questionnaire will also be used to assess adherence and may be particularly helpful if patients receive some antidepressant medication fills outside of the VA. It has been validated using Medication Event Monitoring System (MEMS) caps and found to be 80-100% sensitive for repeat non-adherence and 90% sensitive for sporadic non-adherence.
- Cognitive Behavioral Therapy Skills [ Time Frame: change over time (baseline, 3 months, 6 months) ]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.
- initiation and completion of traditional psychotherapy [ Time Frame: change over time (baseline, 3 months, 6 months) ]Receipt of VA and non-VA Traditional In-Person Psychotherapy: We will review enrolled patients' VA medical record notes to determine their receipt of any traditional in-person psychotherapy and their completion of 8 in-person psychotherapy visits within 3 and 6 months following enrollment. We will also assess whether the Veteran received psychotherapy that was depression focused and evidence-based, assessing the presence of key phrases in notes that denote CBT, Acceptance and Commitment Therapy (ACT), or Interpersonal Therapy (IPT) treatment. We will also determine non-VA psychotherapy use, using the Cornell Services Index, as patients may have started non-VA psychotherapy after enrollment. Finally, we will construct variables that indicate if the Veteran received any in-person psychotherapy (y/n), completed an adequate trial of any psychotherapy (y/n), received any evidence-based VA psychotherapy (y/n), and completed a trial of evidence-based VA psychotherapy (y/n).
- Anxiety [ Time Frame: change over time (baseline, 3 months, 6 months) ]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.
- Suicidal Ideation [ Time Frame: change over time (baseline, 3 months, 6 months) ]Suicidal Ideation will be measured with the Beck Scale for Suicide Ideation (BSS). The BSS is designed to measure the intensity, pervasiveness, and characteristics of suicide ideation. The BSS has five screening items to decrease the length and the intrusiveness of the questionnaire for non-suicidal patients. If patients have a positive screen, they go on to answer the remaining 14 items, for a total of 21 items. The 21 items are scored on a 3-point Likert scale from 0= not present to 2= maximum severity of suicidal ideation. The score is calculated by summing the ratings for the first 19 items, with scores ranging from 0-38. The scale has good internal consistency with a Cronbach's alpha ranging between 0.87-0.97. The scale also shows evidence of construct and discriminant validity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057042
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Battle Creek VA Medical Center, Battle Creek, MI|
|Battle Creek, Michigan, United States, 49037|
|John D. Dingell VA Medical Center, Detroit, MI|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Paul N Pfeiffer, MD MS||VA Ann Arbor Healthcare System, Ann Arbor, MI|