Overview

This trial is active, not recruiting.

Condition major depression
Treatments conventional cognitive behavioral therapy, religious cognitive behavioral therapy
Sponsor Duke University
Start date April 2011
End date July 2014
Trial size 100 participants
Trial identifier NCT01208428, Pro00026533

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression
conventional cognitive behavioral therapy
Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.
(Experimental)
Subjects randomized to this arm will receive conventional cognitive behavioral therapy, but their religious beliefs will be utilized as a resource in the therapy
religious cognitive behavioral therapy
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

Primary Outcomes

Measure
Beck Depression Inventory
time frame: Baseline
Beck Depression Inventory
time frame: 4 weeks
Beck Depression Inventory
time frame: 8 weeks
Beck Depression Inventory
time frame: 12 weeks
Beck Depression Inventory
time frame: 24 weeks

Secondary Outcomes

Measure
Duke Social Support Index (abbreviated)
time frame: Baseline
Duke Social Support Index (abbreviated)
time frame: 12 weeks
Duke Social Support Index
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness
Principal investigator Harold G Koenig, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Duke University.