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Group CBT for Depression and AOD Disorders (BRIGHT2)

Primary Purpose

Depression, Substance Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Group CBT for Depression and AOD Disorders
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Substance Use, Group Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Behavioral Health Services, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Clients are invited to attend 18 group CBT sessions

Clients receive usual care

Outcomes

Primary Outcome Measures

Reductions in depressive symptoms as measured by the BDI II
Reductions in AOD use

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
November 10, 2011
Sponsor
RAND
Collaborators
Behavioral Health Services, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01154309
Brief Title
Group CBT for Depression and AOD Disorders
Acronym
BRIGHT2
Official Title
Group Cognitive Behavioral Therapy for Depression and Alcohol and Other Drug Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Behavioral Health Services, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will adapt and test an existing treatment (group CBT for depression) for use in outpatient substance use treatment settings as delivered by trained substance use counselors. The investigators expect that treatment will lead to improved depression and substance use outcomes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance Use
Keywords
Depression, Substance Use, Group Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Clients are invited to attend 18 group CBT sessions
Arm Title
2
Arm Type
No Intervention
Arm Description
Clients receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Group CBT for Depression and AOD Disorders
Intervention Description
18 sessions of 2-hour group CBT
Primary Outcome Measure Information:
Title
Reductions in depressive symptoms as measured by the BDI II
Time Frame
Post treatment
Title
Reductions in AOD use
Time Frame
Post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine E Watkins, MD, MSHS
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Health Services, Inc
City
Gardena
State/Province
California
ZIP/Postal Code
90249
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Group CBT for Depression and AOD Disorders

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