Cognitive Behavioral Treatments for Depression in Chronic Illness

Duke University Medical Center in collaboration with Glendale Adventist Medical Center
propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs.
religious cognitive behavior therapy (RCBT) for major depression in medical patients with
chronic disabling illness. Therapists will deliver the treatment in real time over the
Internet and/or by telephone to increase treatment access. This planning grant seeks
support for a two-site study (North Carolina and California) that consists of two phases.
In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to
assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance
with treatment, acceptability of treatment and delivery system (online vs. telephone), and
allow therapists gain experience with delivery system and RCBT.

In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept
comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected
clinically meaningful difference for a definitive R01 application. In Phase II, 70
religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35
on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness
will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions
administered by master's level therapists and delivered over 12 weeks. The primary endpoint
will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu,
Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each
of these traditions will supervise therapists delivering the intervention to patients from
these faith traditions.

The purpose of this study is to determine feasibility and effect sizes for a future, fully
powered treatment study. The importance is that results will be relevant to therapists well
beyond those who explicitly practice pastoral counseling, extending to many secular
therapists as well. If 65% of Americans indicate that religion is an important part of
daily life and the vast majority of chronically ill medical patients wish to include it in
their therapy, then all therapists (whether they have explicit training in pastoral
counseling or not) are likely to encounter patients in which this approach would be
applicable.