Cognitive Behavioral Treatments for Depression in Chronic Illness

Not Applicable

Completed

• Conditions: Major Depression
• Interventions: Behavioral: Religious cognitive behavioral therapy; Behavioral: Conventional cognitive behavioral therapy

• Registration Number: NCT01208428
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-24
• Study Start: 2011-04
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Religious cognitive behavioral therapy	Religious cognitive behavioral therapy	Subjects randomized to this arm will receive conventional cognitive behavioral therapy, but their religious beliefs will be utilized as a resource in the therapy
Conventional cognitive behavioral therapy	Conventional cognitive behavioral therapy	Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	24 weeks	Quantitative assessment of depressive symptoms

Secondary Outcome Measures

Name	Time	Method
Duke Social Support Index	24 weeks	Measures amount of social support and satisfaction with it.
Duke Social Support Index (abbreviated)	12 weeks	Measures amount of social support and satisfaction with it

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States