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NCT01208428 · ClinicalTrials.gov registry record · NA
Cognitive Behavioral Treatments for Depression in Chronic Illness
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT01208428 is a NA study that has completed, run by Duke University. The registered enrollment target is 132 participants.
The verdict
NCT01208428, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study 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 p
Interventions
- BEHAVIORAL Conventional cognitive behavioral therapy
- BEHAVIORAL Religious cognitive behavioral therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01208428
The ClinicalTrials.gov registry entry for NCT01208428 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conventional cognitive behavioral therapy is the first listed.
NCT01208428 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01208428 about?
NCT01208428 is a clinical study titled "Cognitive Behavioral Treatments for Depression in Chronic Illness". 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. Therap...
What is the current status of trial NCT01208428?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2011-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01208428?
The interventions under investigation include: Conventional cognitive behavioral therapy (BEHAVIORAL), Religious cognitive behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01208428?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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