In a MDA-funded Stage I Behavioral Therapies Development grant (1994- present) that we are now completing, our group has developed a manualized integrated relapse prevention group therapy (""""""""Integrated Group Therapy"""""""") for patients with current comorbid substance dependence and bipolar disorder (BPD). Outcome results for Integrated Group Therapy (IGT) have been promising; patients showed significant improvement in drug use and psychiatric symptoms from baseline to the end of treatment, and from baseline to 3- month post-treatment follow-up. Moreover, in this open, non-randomized pilot study, patients in IGT had significantly fewer days of drug use at the end of treatment and at 3-month post-treatment follow-up than did a comparison group of patients who received no experimental group treatment, but had monthly assessments. The primary aim of our current competing continuation proposal is to extend the work accomplished under this previous award (DA09400) by conducting a randomized. controlled Stage lb study in 60 patients, comparing 20 weekly sessions of Integrated Group Therapy (in which both BPD and substance use disorder are addressed simultaneously) versus an equivalent amount of an active comparison treatment, namely, Group Drug Counseling; the latter treatment focuses exclusively on the patients' substance use disorder, without focusing on BPD. We plan to assess patients monthly and will compare treatment outcomes for IGT versus Group Drug Counseling (GDC) at 5 months (i.e., the end of treatment), 8 months (3-month post-treatment follow-up), and one year (7-month post-treatment follow-up). We hypothesize that patients in IGT will have better outcomes than will patients who receive GDC, as measured by (a) days of drug use and (b) BPD symptoms. We plan to use effect sizes from the proposed study to help us in preparation for a larger-scale subsequent Stage II study.
Our second aim i s to compare the impact of these two treatments on a number of secondary outcome measures, including treatment retention, patient satisfaction, medication compliance, overall functioning, and engagement in HIV risk behaviors.
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