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

This study has been completed.
Sponsor:
Collaborator:
Behavioral Health Services, Inc.
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01191788
First received: June 29, 2010
Last updated: May 22, 2012
Last verified: May 2012
  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.


Condition Intervention Phase
Depression
Substance Use
Behavioral: Group Cognitive Behavioral Therapy
Behavioral: Group CBT for Depression
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Group Cognitive Behavioral Therapy (CBT) For Depression in Clients With Alcohol and Other Drug (AOD) Disorders

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Depressive Symptoms as Measured by the Beck Depression Inventory II [ Time Frame: 3 Months Post Treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mental Health Functioning as Measured by SF-12 MCS. [ Time Frame: 3 Months Post Treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 299
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01191788

Locations
United States, California
Behavioral Health Services, Inc
Gardena, California, United States, 90249
Sponsors and Collaborators
RAND
Behavioral Health Services, Inc.
Investigators
Principal Investigator: Katherine Watkins, MD, MSHS RAND
  More Information

Additional Information:
No publications provided by RAND

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01191788     History of Changes
Other Study ID Numbers: R01AA014699-03, R01AA014699
Study First Received: June 29, 2010
Results First Received: October 24, 2011
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
Depression
Substance Use
Group Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014