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Modifying Group Therapy for Bipolar Substance Abusers - 1

Primary Purpose

Bipolar Disorder, Substance Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring substance abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: bipolar disorder substance dependence taking a mood stabilizer Exclusion Criteria: acute psychosis no substance use in past 60 days no prescribing doctor will not be in area for next 15 months lives too far away

Sites / Locations

  • McLean Hospital, Dept. of Psychiatry

Outcomes

Primary Outcome Measures

Addiction severity

Secondary Outcome Measures

Full Information

First Posted
September 27, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00227838
Brief Title
Modifying Group Therapy for Bipolar Substance Abusers - 1
Official Title
Modifying Group Therapy for Bipolar Abusers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so that it can be more readily adopted by community drug abuse treatment programs. IGT is being reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug counselors, to test its effectiveness in a more community-based setting. The training has been expanded so that counselors without much psychopathology training or cognitive behavioral therapy experience can conduct IGT.
Detailed Description
IGT is being compared with 12 sessions of Group Drug Counseling (GDC) in a randomized controlled trial, with a sample size of 60 subjects. GDC is the type of treatment one would likely receive in a community drug abuse treatment program, in that it focuses primarily in substance use, unlike IGT, which focuses equally on SUD and BD issues. Patients are followed for a year after the end of the group therapy, to examine the long-term effects of the treatment, and also to examine the longer-term relationship of substance use and mood. Patients in the trial must be taking a mood stabilizer to enter the study. Any drug of abuse is accepted, and all subtypes of BD are accepted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Substance Dependence
Keywords
substance abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Primary Outcome Measure Information:
Title
Addiction severity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bipolar disorder substance dependence taking a mood stabilizer Exclusion Criteria: acute psychosis no substance use in past 60 days no prescribing doctor will not be in area for next 15 months lives too far away
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Weiss, M.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital, Dept. of Psychiatry
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478 9106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21314751
Citation
McDonald LJ, Griffin ML, Kolodziej ME, Fitzmaurice GM, Weiss RD. The impact of drug use in social networks of patients with substance use and bipolar disorders. Am J Addict. 2011 Mar-Apr;20(2):100-5. doi: 10.1111/j.1521-0391.2010.00117.x. Epub 2011 Feb 1.
Results Reference
derived
PubMed Identifier
19573999
Citation
Weiss RD, Griffin ML, Jaffee WB, Bender RE, Graff FS, Gallop RJ, Fitzmaurice GM. A "community-friendly" version of integrated group therapy for patients with bipolar disorder and substance dependence: a randomized controlled trial. Drug Alcohol Depend. 2009 Oct 1;104(3):212-9. doi: 10.1016/j.drugalcdep.2009.04.018. Epub 2009 Jul 1.
Results Reference
derived
PubMed Identifier
19192456
Citation
Jaffee WB, Griffin ML, Gallop R, Meade CS, Graff F, Bender RE, Weiss RD. Depression precipitated by alcohol use in patients with co-occurring bipolar and substance use disorders. J Clin Psychiatry. 2009 Feb;70(2):171-6. doi: 10.4088/jcp.08m04011. Epub 2008 Dec 30.
Results Reference
derived
Links:
URL
http://www.mclean.org
Description
Related Info

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Modifying Group Therapy for Bipolar Substance Abusers - 1

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