Group CBT for Depression and AOD Disorders

NCT ID: NCT01154309

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Substance Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Clients are invited to attend 18 group CBT sessions

Group Type EXPERIMENTAL

Group CBT for Depression and AOD Disorders

Intervention Type BEHAVIORAL

18 sessions of 2-hour group CBT

2

Clients receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group CBT for Depression and AOD Disorders

18 sessions of 2-hour group CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Behavioral Health Services, Inc.

INDUSTRY

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katherine E Watkins, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Behavioral Health Services, Inc

Gardena, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA020159

Identifier Type: NIH

Identifier Source: org_study_id

View Link