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Integrated Intervention for Substance Abusers With Depressive Disorders

Primary Purpose

Substance-Related Disorders, Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Twelve Step Facilitation
Integrated Cognitive Behavioral Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Mood Disorders, Substance-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Twelve Step Facilitation

Integrated Cognitive Behavioral Treatment

Outcomes

Primary Outcome Measures

Hamilton Depression Scale, Timeline Follow-back (substance measure)

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
April 17, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00018655
Brief Title
Integrated Intervention for Substance Abusers With Depressive Disorders
Official Title
Integrated Intervention for Substance Abusers With Depressive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Depressive Disorder
Keywords
Mood Disorders, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Twelve Step Facilitation
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Integrated Cognitive Behavioral Treatment
Intervention Type
Behavioral
Intervention Name(s)
Twelve Step Facilitation
Intervention Description
Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Cognitive Behavioral Treatment
Intervention Description
Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale, Timeline Follow-back (substance measure)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Tate, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17373561
Citation
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. doi: 10.1080/02791072.2006.10400584.
Results Reference
background
PubMed Identifier
18295436
Citation
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. doi: 10.1016/j.jsat.2007.12.005. Epub 2008 Mar 4.
Results Reference
result
PubMed Identifier
17690799
Citation
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. doi: 10.15288/jsad.2007.68.663.
Results Reference
result
PubMed Identifier
20853931
Citation
Lydecker KP, Tate SR, Cummins KM, McQuaid J, Granholm E, Brown SA. Clinical outcomes of an integrated treatment for depression and substance use disorders. Psychol Addict Behav. 2010 Sep;24(3):453-65. doi: 10.1037/a0019943.
Results Reference
result
PubMed Identifier
21517712
Citation
Granholm E, Tate SR, Link PC, Lydecker KP, Cummins KM, McQuaid J, Shriver C, Brown SA. Neuropsychological functioning and outcomes of treatment for co-occurring depression and substance use disorders. Am J Drug Alcohol Abuse. 2011 Jul;37(4):240-9. doi: 10.3109/00952990.2011.570829. Epub 2011 Apr 26.
Results Reference
result
PubMed Identifier
21679267
Citation
Tate SR, Mrnak-Meyer J, Shriver CL, Atkinson JH, Robinson SK, Brown SA. Predictors of treatment retention for substance-dependent adults with co-occurring depression. Am J Addict. 2011 Jul-Aug;20(4):357-65. doi: 10.1111/j.1521-0391.2011.00137.x. Epub 2011 May 31.
Results Reference
result
PubMed Identifier
22406052
Citation
Worley MJ, Trim RS, Roesch SC, Mrnak-Meyer J, Tate SR, Brown SA. Comorbid depression and substance use disorder: longitudinal associations between symptoms in a controlled trial. J Subst Abuse Treat. 2012 Oct;43(3):291-302. doi: 10.1016/j.jsat.2011.12.010. Epub 2012 Mar 8.
Results Reference
result
PubMed Identifier
20598832
Citation
Worley MJ, Trim RS, Tate SR, Hall JE, Brown SA. Service utilization during and after outpatient treatment for comorbid substance use disorder and depression. J Subst Abuse Treat. 2010 Sep;39(2):124-31. doi: 10.1016/j.jsat.2010.05.009. Epub 2010 Jul 3.
Results Reference
result
PubMed Identifier
21815915
Citation
Mrnak-Meyer J, Tate SR, Tripp JC, Worley MJ, Jajodia A, McQuaid JR. Predictors of suicide-related hospitalization among U.S. veterans receiving treatment for comorbid depression and substance dependence: who is the riskiest of the risky? Suicide Life Threat Behav. 2011 Oct;41(5):532-42. doi: 10.1111/j.1943-278X.2011.00051.x. Epub 2011 Aug 4.
Results Reference
result
PubMed Identifier
22578037
Citation
Worley MJ, Tate SR, Brown SA. Mediational relations between 12-Step attendance, depression and substance use in patients with comorbid substance dependence and major depression. Addiction. 2012 Nov;107(11):1974-83. doi: 10.1111/j.1360-0443.2012.03943.x. Epub 2012 Aug 10.
Results Reference
result
PubMed Identifier
23327503
Citation
Worley MJ, Tate SR, McQuaid JR, Granholm EL, Brown SA. 12-step affiliation and attendance following treatment for comorbid substance dependence and depression: a latent growth curve mediation model. Subst Abus. 2013;34(1):43-50. doi: 10.1080/08897077.2012.691451.
Results Reference
result
PubMed Identifier
24223036
Citation
Tripp JC, Skidmore JR, Cui R, Tate SR. Impact of Physical Health on Treatment for Co-occurring Depression and Substance Dependence. J Dual Diagn. 2013;9(3):10.1080/15504263.2013.806111. doi: 10.1080/15504263.2013.806111.
Results Reference
result
PubMed Identifier
24588403
Citation
Worley MJ, Tate SR, Granholm E, Brown SA. Mediated and moderated effects of neurocognitive impairment on outcomes of treatment for substance dependence and major depression. J Consult Clin Psychol. 2014 Jun;82(3):418-28. doi: 10.1037/a0036033. Epub 2014 Mar 3.
Results Reference
derived

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Integrated Intervention for Substance Abusers With Depressive Disorders

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