Integrated Intervention for Substance Abusers With Depressive Disorders

This study has been terminated.
(PI has been contacted numerous times for an update, with no response. ORD requested a close out of this project. 10/2011)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018655
First received: July 3, 2001
Last updated: March 20, 2012
Last verified: March 2012
  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 2

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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Sandra Brown, PhD VA San Diego Healthcare System, San Diego
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: March 20, 2012
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
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2014