NCT01208428

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

September 22, 2010

Last Update Submit

March 13, 2015

Conditions

Major Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Duke Social Support Index (abbreviated)

    Baseline

  • Duke Social Support Index (abbreviated)

    12 weeks

  • Duke Social Support Index

    24 weeks

Study Arms (2)

Conventional cognitive behavioral therapy

ACTIVE COMPARATOR

Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression

Behavioral: Conventional cognitive behavioral therapy

Religious cognitive behavioral therapy

EXPERIMENTAL

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

Interventions

Conventional cognitive behavioral therapyBEHAVIORAL

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

Conventional cognitive behavioral therapy
Religious cognitive behavioral therapyBEHAVIORAL

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

Religious cognitive behavioral therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • significant cognitive impairment
  • significant suicidal thoughts or risk
  • no access to telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glendale Adventist Medical Center

Glendale, California, 91201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • 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.

    PMID: 1556292BACKGROUND

  • 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.

    PMID: 17502804BACKGROUND

  • 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.

    PMID: 9546001BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Harold G Koenig, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 24, 2010

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(2)