Cognitive Behavioral Treatments for Depression in Chronic Illness

Cognitive Behavioral Treatments for Depression in Patients With 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. 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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: Conventional cognitive behavioral therapy; Behavioral: Religious cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91201
      • Glendale Adventist Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Quantitative assessment of depressive symptoms	Baseline
Beck Depression Inventory	Quantitative assessment of depressive symptoms	4 weeks
Beck Depression Inventory	Quantitative assessment of depressive symptoms	8 weeks
Beck Depression Inventory	Quantitative assessment of depressive symptoms	12 weeks
Beck Depression Inventory	Quantitative assessment of depressive symptoms	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duke Social Support Index (abbreviated)	Measures amount of social support and satisfaction with it.	Baseline
Duke Social Support Index (abbreviated)	Measures amount of social support and satisfaction with it	12 weeks
Duke Social Support Index	Measures amount of social support and satisfaction with it.	24 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Harold G Koenig, MD, Duke University

Publications and helpful links

General Publications

• 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. doi: 10.1037//0022-006x.60.1.94.
• 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. doi: 10.1097/NMD.0b013e31802f58e3.
• 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. doi: 10.1176/ajp.155.4.536.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: September 22, 2010
• First Posted (ESTIMATE): September 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Disease Attributes; Depression; Depressive Disorder; Chronic Disease
• Other Study ID Numbers: Pro00026533