Cognitive Behavioral Treatments for Depression in Chronic Illness

Major Depression Clinical Trial

Official title:

Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208428
• Other study ID #: Pro00026533
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: March 13, 2015
• Start date: April 2011
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Conventional cognitive behavioral therapy
Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Glendale Adventist Medical Center	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Koenig HG, George LK, Peterson BL. Religiosity and remission of depression in medically ill older patients. Am J Psychiatry. 1998 Apr;155(4):536-42. — View Citation

Koenig HG. Religion and remission of depression in medical inpatients with heart failure/pulmonary disease. J Nerv Ment Dis. 2007 May;195(5):389-95. — View Citation

Propst LR, Ostrom R, Watkins P, Dean T, Mashburn D. Comparative efficacy of religious and nonreligious cognitive-behavioral therapy for the treatment of clinical depression in religious individuals. J Consult Clin Psychol. 1992 Feb;60(1):94-103. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory	Quantitative assessment of depressive symptoms	Baseline	Yes
Primary	Beck Depression Inventory	Quantitative assessment of depressive symptoms	4 weeks	Yes
Primary	Beck Depression Inventory	Quantitative assessment of depressive symptoms	8 weeks	Yes
Primary	Beck Depression Inventory	Quantitative assessment of depressive symptoms	12 weeks	Yes
Primary	Beck Depression Inventory	Quantitative assessment of depressive symptoms	24 weeks	Yes
Secondary	Duke Social Support Index (abbreviated)	Measures amount of social support and satisfaction with it.	Baseline	No
Secondary	Duke Social Support Index (abbreviated)	Measures amount of social support and satisfaction with it	12 weeks	No
Secondary	Duke Social Support Index	Measures amount of social support and satisfaction with it.	24 weeks	No