Cognitive Behavioral Treatments for Depression in Chronic Illness

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01208428
First received: September 22, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Major Depression
Behavioral: Conventional cognitive behavioral therapy
Behavioral: Religious cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Quantitative assessment of depressive symptoms

  • Beck Depression Inventory [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Quantitative assessment of depressive symptoms

  • Beck Depression Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Quantitative assessment of depressive symptoms

  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Quantitative assessment of depressive symptoms

  • Beck Depression Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Quantitative assessment of depressive symptoms


Secondary Outcome Measures:
  • Duke Social Support Index (abbreviated) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measures amount of social support and satisfaction with it.

  • Duke Social Support Index (abbreviated) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measures amount of social support and satisfaction with it

  • Duke Social Support Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measures amount of social support and satisfaction with it.


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208428

Locations
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
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Harold G Koenig, MD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01208428     History of Changes
Other Study ID Numbers: Pro00026533
Study First Received: September 22, 2010
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Depression

Additional relevant MeSH terms:
Chronic Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Disease Attributes
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014