Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression

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.

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