Cognitive Behavioral Treatments for Depression in Chronic Illness
|ClinicalTrials.gov Identifier: NCT01208428|
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : March 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Behavioral: Conventional cognitive behavioral therapy Behavioral: Religious cognitive behavioral therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
Active Comparator: Conventional cognitive behavioral therapy
Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression
Behavioral: Conventional cognitive behavioral therapy
Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.
Experimental: 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
Behavioral: 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
- Beck Depression Inventory [ Time Frame: Baseline ]Quantitative assessment of depressive symptoms
- Beck Depression Inventory [ Time Frame: 4 weeks ]Quantitative assessment of depressive symptoms
- Beck Depression Inventory [ Time Frame: 8 weeks ]Quantitative assessment of depressive symptoms
- Beck Depression Inventory [ Time Frame: 12 weeks ]Quantitative assessment of depressive symptoms
- Beck Depression Inventory [ Time Frame: 24 weeks ]Quantitative assessment of depressive symptoms
- Duke Social Support Index (abbreviated) [ Time Frame: Baseline ]Measures amount of social support and satisfaction with it.
- Duke Social Support Index (abbreviated) [ Time Frame: 12 weeks ]Measures amount of social support and satisfaction with it
- Duke Social Support Index [ Time Frame: 24 weeks ]Measures amount of social support and satisfaction with it.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208428
|United States, California|
|Glendale Adventist Medical Center|
|Glendale, California, United States, 91201|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Harold G Koenig, MD||Duke University|