Building Recovery By Improving Goals, Habits, and Thoughts (BRIGHT)

September 21, 2022 updated by: RAND

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Gardena, California, United States, 90249
        • Behavioral Health Services, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group CBT
Clients received up to 16 sessions of group CBT for depression
Behavioral: Group Cognitive Behavioral Therapy
16 two hour sessions of group CBT
Behavioral: Group CBT for Depression
16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
Active Comparator: Comparison
Treatment as Usual comparison condition
Behavioral: Group Cognitive Behavioral Therapy
16 two hour sessions of group CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms as Measured by the Beck Depression Inventory II
Time Frame: 3 Months Post Treatment
The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
3 Months Post Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Functioning as Measured by SF-12 MCS.
Time Frame: 3 Months Post Treatment
The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.
3 Months Post Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Behavioral Health Services, Inc.

Investigators

  • Principal Investigator: Katherine Watkins, MD, MSHS, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AA014699-03 (U.S. NIH Grant/Contract)
  • R01AA014699 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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