Building Recovery By Improving Goals, Habits, and Thoughts (BRIGHT)
|ClinicalTrials.gov Identifier: NCT01191788|
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : June 25, 2012
Last Update Posted : June 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression Substance Use||Behavioral: Group Cognitive Behavioral Therapy Behavioral: Group CBT for Depression||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||March 2010|
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 CBTBehavioral: 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191788
|United States, California|
|Behavioral Health Services, Inc|
|Gardena, California, United States, 90249|
|Principal Investigator:||Katherine Watkins, MD, MSHS||RAND|