NCT00227838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2005

Enrollment Period

1.9 years

First QC Date

September 27, 2005

Last Update Submit

January 11, 2017

Conditions

Keywords

substance abuse

Outcome Measures

Primary Outcomes (1)

  • Addiction severity

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bipolar disorder substance dependence taking a mood stabilizer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital, Dept. of Psychiatry

Belmont, Massachusetts, 02478 9106, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Bipolar DisorderSubstance-Related Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Roger Weiss, M.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

July 1, 2003

Primary Completion

June 1, 2005

Study Completion

August 1, 2005

Last Updated

January 12, 2017

Record last verified: 2005-09

Locations