Integrated Intervention for Substance Abusers With Depressive Disorders

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00018655
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Arms: 2
• Duration (Months): 149
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Apr 1, 2000
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Hamilton Depression Scale, Timeline Follow-back (substance measure) [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Brown SA, Glasner-Edwards SV, Tate SR, McQuaid JR, Chalekian J, Granholm E. Integrated cognitive behavioral therapy versus twelve-step facilitation therapy for substance-dependent adults with depressive disorders. J Psychoactive Drugs. 2006 Dec;38(4):449-60.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00018655
• Other Study ID Numbers: MHBS-041-99S
• First Posted: Jul 5, 2001
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by VA Office of Research and Development: Mood Disorders; Substance-Related Disorders
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Depressive Disorder; Depression

Study Results

No Results Posted as of Apr 19, 2019