Expired Study
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Gardena, California 90249


Purpose:

The investigators will investigate whether group Cognitive Behavioral Therapy (CBT) for depression, with alcohol and other drug (AOD) treatment counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. 360 clients with Beck Depression Inventory-II scores > 17 who are being treated in a single public sector AOD treatment organization will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Data will be analyzed using an intent-to-treat model. The investigators will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC.


Study summary:

Individuals with alcohol and other drug (AOD) disorders frequently suffer from depression, leading to reduced quality of life and poorer AOD treatment outcomes. Efficacious treatments for depression do exist and could improve outcomes; but national data suggest that fewer than 7% of people with co-occurring disorders who are in AOD treatment have received appropriate treatment. Group cognitive behavioral therapy (CBT) is an effective and inexpensive treatment for depression. We propose to investigate whether group CBT for depression, with AOD counselors leading the groups, is effective and cost effective in treating depression. If so, it could substantially increase access to appropriate mental health care. We propose a 5-year quasi-experimental study with the following specific aims: Aim 1. To evaluate the effectiveness of group CBT for depression provided by AOD counselors in improving depressive symptoms and AOD outcomes, among clients being treated in public sector residential AOD treatment settings; Aim 2. To evaluate the cost-effectiveness of group CBT conducted by trained AOD counselors compared to usual care AOD treatment; Aim 3. To document the implementation of the intervention at each of the four sites, and to determine whether the AOD counselors are delivering the group CBT intervention with fidelity to the model, and whether treatment fidelity is a significant predictor of client outcomes. We will enroll and follow 360 clients with Beck Depression Inventory-II (BDI-II) scores > 17 who are being treated in a single public sector AOD treatment organization at four residential sites in LA County. Subjects will receive one of two conditions: (1) usual care residential AOD treatment (UC); (2) usual care AOD residential treatment plus a 16-session course of group CBT delivered by trained AOD counselors (CBT). Subjects will complete: (1) a baseline interview; (2) a post-treatment interview (at the conclusion of the CBT treatment) and (3) a follow-up interview (3 months after CBT treatment ends). Data will be analyzed using an intent-to-treat model. We will collect data on the service-level costs and health effects associated with UC and CBT, and will calculate the incremental cost per unit of depression and AOD improvement, compared to UC. . The implementation analysis will involve two related sets of activities: (1) a series of key informant interviews to provide a context in which to understand intervention implementation and (2) an assessment of treatment fidelity and it's relationship to client outcomes.


Criteria:

Inclusion Criteria: - present for treatment at one of four participating sites during study period - score BDI>17 at 2-4 weeks post-treatment entry Exclusion Criteria: - cognitive impairment (score of 11 or greater on short Blessed exam) - screen positive for bipolar or schizophrenia - non-English speaker


Study is Available At:


Original ID:

R01AA014699-03


NCT ID:

NCT01191788


Secondary ID:

R01AA014699


Study Acronym:

BRIGHT


Brief Title:

Building Recovery By Improving Goals, Habits, and Thoughts


Official Title:

Group Cognitive Behavioral Therapy (CBT) For Depression in Clients With Alcohol and Other Drug (AOD) Disorders


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

RAND


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

299


Enrollment Type:

Actual


Overall Contact Information

Official Name:Katherine Watkins, MD, MSHS
Principal Investigator
RAND

Study Dates

Start Date:August 2006
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:January 18, 2011
First Received Date:June 29, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improved mental health functioning as measured by SF-12 and reduced negative consequences from substance use as measured by the Shortened Inventory of Problems
Time Frame:3 Months Post Treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Depressive symptoms as measured by the Beck Depression Inventory II
Time Frame:3 Months Post Treatment
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Group Cognitive Behavioral Therapy
Arm Name:Group CBT
Intervention Type:Behavioral
Name:Group CBT for Depression
Description:16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
Arm Name:Group CBT

Study Arms

Study Arm Type:Experimental
Arm Name:Group CBT
Description:Clients received up to 16 sessions of group CBT for depression
Study Arm Type:Active Comparator
Arm Name:Comparison
Description:Treatment as Usual comparison condition

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:RAND
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Behavioral Health Services, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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