Cognitive Behavioral Treatments for Depression in Chronic Illness

Duke University

Status: Completed

Conditions: Major Depression

Treatments: Behavioral: Religious cognitive behavioral therapy; Behavioral: Conventional cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01208428

Pro00026533

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic disabling medical illness
• religion at least somewhat important to patient
• major depressive disorder by MINI neuropsychiatric interview
• Beck Depression Inventory scores of 16-28 (moderately severe depression)
• live near Durham, North Carolina, or near Glendale, in Southern California

Exclusion criteria

• significant cognitive impairment
• significant suicidal thoughts or risk
• no access to telephone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Conventional cognitive behavioral therapy

Active Comparator group

Description:

Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression

Treatment:

Behavioral: Conventional cognitive behavioral therapy

Religious cognitive behavioral therapy

Experimental group

Description:

Subjects randomized to this arm will receive conventional cognitive behavioral therapy, but their religious beliefs will be utilized as a resource in the therapy

Treatment:

Behavioral: Religious cognitive behavioral therapy