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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

June 29, 2010
May 22, 2012
August 2006
July 2009   (final data collection date for primary outcome measure)
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.
Depressive symptoms as measured by the BDI II [ Time Frame: 3 Months Post Treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01191788 on ClinicalTrials.gov Archive Site
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.
Improved functioning as measured by SF-12 and reduced negative consequences from substance use as measured by the SIP [ Time Frame: 3 Months Post Treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Building Recovery By Improving Goals, Habits, and Thoughts
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Depression
  • Substance Use
  • 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
  • Experimental: Group CBT
    Clients received up to 16 sessions of group CBT for depression
    Interventions:
    • Behavioral: Group Cognitive Behavioral Therapy
    • Behavioral: Group CBT for Depression
  • Active Comparator: Comparison
    Treatment as Usual comparison condition
    Intervention: Behavioral: Group Cognitive Behavioral Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
March 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01191788
R01AA014699-03, R01AA014699
Yes
RAND
RAND
Behavioral Health Services, Inc.
Principal Investigator: Katherine Watkins, MD, MSHS RAND
RAND
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP