Integrated Intervention for Substance Abusers With Depressive Disorders - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018655

Purpose

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.

Condition	Intervention	Phase
Substance-Related Disorders Depressive Disorder	Behavioral: Twelve Step Facilitation Behavioral: Integrated Cognitive Behavioral Treatment	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Integrated Intervention for Substance Abusers With Depressive Disorders

Resource links provided by NLM:

MedlinePlus related topics: Depression Drug Abuse

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Hamilton Depression Scale, Timeline Follow-back (substance measure) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	276
Study Start Date:	April 2000
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Twelve Step Facilitation	Behavioral: Twelve Step Facilitation Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
Experimental: 2 Integrated Cognitive Behavioral Treatment	Behavioral: Integrated Cognitive Behavioral Treatment Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.

Detailed Description:

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included.

Exclusion Criteria:

Psychotic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018655

Locations

United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Sandra Brown, PhD

VA San Diego Healthcare System, San Diego

More Information

Publications:

Glasner-Edwards S, Tate SR, McQuaid JR, Cummins K, Granholm E, Brown SA. Mechanisms of action in integrated cognitive-behavioral treatment versus twelve-step facilitation for substance-dependent adults with comorbid major depression. J Stud Alcohol Drugs. 2007 Sep;68(5):663-72.

Drapkin ML, Tate SR, McQuaid JR, Brown SA. Does initial treatment focus influence outcomes for depressed substance abusers? J Subst Abuse Treat. 2008 Oct;35(3):343-50. Epub 2008 Mar 4.

Responsible Party:	Brown, Sandra - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018655 History of Changes
Other Study ID Numbers:	MHBS-041-99S
Study First Received:	July 3, 2001
Last Updated:	November 15, 2010
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Mood Disorders
Substance-Related Disorders

Additional relevant MeSH terms:

Depressive Disorder
Depression
Substance-Related Disorders

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 12, 2012