Clinical trial NCT02057042: Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
Official title: Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Peer Support
cCBT
primary care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-02-06
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients will be eligible for the study if they:

* have new episodes of depression in primary care, defined as those with a new diagnoses of depression and no prior depression diagnoses or antidepressant fills within 120 days of the index date of their depression diagnosis any of three VA study sites or associated CBOCs. Patients must enroll within 90 days of their diagnosis.
* have a current Patient Health Questionnaire (PHQ)-9 score \> 10.
* are not receiving mental health care outside of VHA.
* have broadband internet access at home or confirm willingness, ability, and a plan to go to their VA facility to complete cCBT modules.
* have familiarity with email and internet use.
* have stable access to and ability to communicate by telephone.

Exclusion Criteria:

Exclusion criteria for the study will include:

* a diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) with psychotic features, or Bipolar I in the past 24 months.
* a positive screen for moderate or severe substance use (AUDIT-C \>7).
* an immediate risk of suicide, requiring hospitalization or urgent evaluation (as evidenced by suicidal plan or intent).
* participating in other research studies.
* diagnosis of depression in the past 4 months from a non-VA provider

Primary outcomes:
measure: Functional Status
timeFrame: change over time (baseline, 3 months, 6 months)
measure: Depression Symptoms
timeFrame: change over time (baseline, 3 months, 6 months)
measure: Recovery Orientation
timeFrame: change over time (baseline, 3 months, 6 months)
measure: Quality of Life Enjoyment and Satisfaction
timeFrame: change over time (baseline, 3 months, 6 months)
Secondary outcomes:
measure: Cognitive Behavioral Therapy Skills
timeFrame: change over time (baseline, 3 months, 6 months)
measure: Anxiety
timeFrame: change over time (baseline, 3 months, 6 months)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Battle Creek
country: United States
facility: Battle Creek VA Medical Center, Battle Creek, MI
state: Michigan
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Paul N Pfeiffer, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.