Clinical trial NCT01208428: Cognitive Behavioral Treatments for Depression in Chronic Illness
Official title: Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Depression
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 4 weeks
measure: Beck Depression Inventory
timeFrame: 8 weeks
measure: Beck Depression Inventory
timeFrame: 12 weeks
measure: Beck Depression Inventory
timeFrame: 24 weeks
Secondary outcomes:
measure: Duke Social Support Index (abbreviated)
timeFrame: Baseline
measure: Duke Social Support Index (abbreviated)
timeFrame: 12 weeks
measure: Duke Social Support Index
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Harold G Koenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1037//0022-006x.60.1.94.
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. doi: 10.1097/NMD.0b013e31802f58e3.
citation: 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.