Modifying Group Therapy for Bipolar Substance Abusers - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00227838
First received: September 27, 2005
Last updated: November 3, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention
Bipolar Disorder
Substance Dependence
Behavioral: Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modifying Group Therapy for Bipolar Abusers

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Addiction severity

Estimated Enrollment: 60
Study Start Date: July 2003
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227838

Contacts
Contact: Rachel Bender (617)855-2585 rbender@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital, Dept. of Psychiatry Recruiting
Belmont, Massachusetts, United States, 02478 9106
Contact: Roger Weiss, M.D.    617-855-2000      
Sponsors and Collaborators
Investigators
Principal Investigator: Roger Weiss, M.D. Mclean Hospital
  More Information

Additional Information:
No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00227838     History of Changes
Other Study ID Numbers: NIDA-15968-1, R01-15968-1
Study First Received: September 27, 2005
Last Updated: November 3, 2005
Health Authority: NIDA

Additional relevant MeSH terms:
Bipolar Disorder
Substance-Related Disorders
Affective Disorders, Psychotic
Chemically-Induced Disorders
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014