Modifying Group Therapy for Bipolar Substance Abusers - 1

Bipolar Disorder Clinical Trial

Official title:

Modifying Group Therapy for Bipolar Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227838
• Other study ID #: NIDA-15968-1
• Secondary ID: R01-15968-1
• Status: Completed
• Phase: N/A
• First received: September 27, 2005
• Last updated: January 11, 2017
• Start date: July 2003
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: NIDA
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Substance Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Behavior Therapy

Locations

Country	Name	City	State
United States	McLean Hospital, Dept. of Psychiatry	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Addiction severity

External Links

•   Link