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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01154309
Other study ID # R01DA020159
Secondary ID
Status Completed
Phase Phase 1
First received June 29, 2010
Last updated November 10, 2011
Start date September 2006
Est. completion date September 2009

Study information

Verified date November 2011
Source RAND
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group CBT for Depression and AOD Disorders
18 sessions of 2-hour group CBT

Locations

Country Name City State
United States Behavioral Health Services, Inc Gardena California

Sponsors (2)

Lead Sponsor Collaborator
RAND Behavioral Health Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reductions in depressive symptoms as measured by the BDI II Post treatment No
Primary Reductions in AOD use Post treatment No
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