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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00227838 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Modifying Group Therapy for Bipolar Abusers |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | August 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rachel Bender | (617)855-2585 | rbender@mclean.harvard.edu |
| United States, Massachusetts | |
| McLean Hospital, Dept. of Psychiatry | Recruiting |
| Belmont, Massachusetts, United States, 02478 9106 | |
| Contact: Roger Weiss, M.D. 617-855-2000 | |
| Principal Investigator: | Roger Weiss, M.D. | Mclean Hospital |
More Information
| Study ID Numbers: | NIDA-15968-1, R01-15968-1 |
| Study First Received: | September 27, 2005 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00227838 History of Changes |
| Health Authority: | NIDA |
|
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Substance-Related Disorders Disorders of Environmental Origin Psychotic Disorders |
|
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Substance-Related Disorders Disorders of Environmental Origin |
