- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01154309
Group CBT for Depression and AOD Disorders (BRIGHT2)
Group Cognitive Behavioral Therapy for Depression and Alcohol and Other Drug Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1. To adapt an existing group therapy (CBT for depression), creating a manualized treatment and accompanying implementation measures and tools for use with clients with persistent depressive symptoms and AOD disorders and to obtain preliminary assessments of the treatment from patient and provider perspectives.
Aim 2. To conduct a pilot test of the revised treatment in which we (a) demonstrate that when the therapy is implemented with fidelity, clinically significant reductions in depressive symptoms and AOD use occur; (b) estimate the likely effect size; and (c) investigate the underlying mechanisms of change, including both cognitive-behavioral and group processes and their relationship to depression and AOD treatment outcomes.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Gardena, California, United States, 90249
- Behavioral Health Services, Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled in outpatient substance abuse program
- BDI II score >13
- Probable alcohol or substance use problem
Exclusion Criteria:
- Cognitive impairment (Short Blessed > 10)
- Probably bipolar or schizophrenic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Clients are invited to attend 18 group CBT sessions
|
18 sessions of 2-hour group CBT
|
|
No Intervention: 2
Clients receive usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reductions in depressive symptoms as measured by the BDI II
Time Frame: Post treatment
|
Post treatment
|
|
Reductions in AOD use
Time Frame: Post treatment
|
Post treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine E Watkins, MD, MSHS, RAND
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA020159 (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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