Building Recovery By Improving Goals, Habits, and Thoughts (BRIGHT)
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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 |
- 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.
- 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
United States, California | |
Behavioral Health Services, Inc | |
Gardena, California, United States, 90249 |
Principal Investigator: | Katherine Watkins, MD, MSHS | RAND |
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 Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on October 17, 2012