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Integrated Intervention for Substance Abusers With Depressive Disorders

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ClinicalTrials.gov Identifier: NCT00018655
Recruitment Status : Terminated (PI has been contacted numerous times for an update, with no response. ORD requested a close out of this project. 10/2011)
First Posted : July 5, 2001
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Substance-Related Disorders Depressive Disorder Behavioral: Twelve Step Facilitation Behavioral: Integrated Cognitive Behavioral Treatment Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Intervention for Substance Abusers With Depressive Disorders
Study Start Date : April 2000
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 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: Arm 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.



Primary Outcome Measures :
  1. Hamilton Depression Scale, Timeline Follow-back (substance measure) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018655


Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00018655     History of Changes
Other Study ID Numbers: MHBS-041-99S
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
Mood Disorders
Substance-Related Disorders

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Substance-Related Disorders
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Chemically-Induced Disorders