Cognitive Behavioral Treatments for Depression in Chronic Illness
Condition: Major Depression
MeSH terms: Chronic Disease; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Conventional cognitive behavioral therapy; Religious cognitive behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.; Religious cognitive behavioral therapy is conventional cognitive behavioral therapy that includes consideration of the patient's religious beliefs in therapy. Subjects will receive ten 50-min sessions of therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression