Modifying Group Therapy for Bipolar Abusers

描述(由申请人提供)：双相情感障碍(BPD)和物质使用障碍(SUD)经常共存，预后不佳。然而，很少有研究关注这一群体。“综合团体疗法”(IGT)侧重于BPD和SUD康复过程中的相似性。在最初的一项开放研究中，IGT患者的用药天数明显少于没有接受IGT治疗的患者。一项正在进行的IB期随机对照试验对60名患者进行了IGT和团体药物咨询(GDC)的比较，GDC主要关注物质使用。前36名患者的初步结果支持IGT，小组会议的出席率显著较高，药物使用、酒精、总体戒酒和情绪结果显著改善。 这项拟议研究的最初目的是通过a)将IGT从20次减少到12次，以及b)修改IGT，使其可以由药物顾问进行，而不是仅由接受过精神病理学和认知行为治疗培训的精神健康专业人员进行，从而使IGT更容易被社区治疗机构采用。将获得患者和咨询师的满意度评分以及对修订手册的外部审查。该手册将不断修订，同时在研究的可行性阶段(即试点前)进行两次修改后的治疗。 一旦手册最终被修订，将对60名受试者进行IB阶段的随机对照试验研究，比较12次修订后的LGT和GDC。组间治疗结果将在3个月(即治疗结束)、6个月和9个月时进行比较。假设修订的IGT将有更好的GDC结果，根据主要结果，a)使用药物的天数，以及b)患BPD的周数。还将比较次要结果，包括治疗保留、患者满意度、服药依从性、总体功能和参与艾滋病毒危险行为。如果结果有根据，拟议研究的效应大小将被用来帮助准备更大规模的后续第二阶段研究。

DESCRIPTION (provided by applicant): Bipolar disorder (BPD) and substance use disorder (SUD) frequently coexist, with poor prognostic implications. However, little research has focused on this population. "Integrated Group Therapy" (IGT) focuses on similarities in the process of recovery from BPD and SUD. In an initial open study, IGT patients had significantly fewer days of drug use than did patients who did not receive IGT. An ongoing Stage IB randomized controlled trial in 60 patients is comparing IGT vs. Group Drug Counseling (GDC), which focuses primarily on substance use. Preliminary results in the first 36 patients have favored IGT, with a significantly higher rate of attendance at group sessions, and significantly better substance use, alcohol, overall abstinence, and mood outcomes. The initial aim of the proposed study is to make IGT more easily adopted by community treatment settings by a) reducing IGT from 20 to 12 sessions and b) modifying IGT so that it can be conducted by drug counselors rather than exclusively by mental health professionals trained in psychopathology and cognitive-behavioral therapy. Patient and counselor satisfaction ratings and outside review of the revised manual will be obtained. The manual will be revised in an ongoing way, while conducting the modified treatment twice in the feasibility (i.e., pre-pilot) phase of the study. Once the manual has been finally revised, a Stage IB randomized controlled pilot study will be conducted with 60 subjects, comparing 12 sessions of revised lGT vs. GDC. Between-group treatment outcomes will be compared at 3 months (i.e., the end of treatment), 6 months, and 9 months. It is hypothesized that revised IGT will have better outcomes GDC, as measured by the primary outcomes, a) days of substance use, and b) number of weeks ill with BPD. Secondary outcomes will also be compared, including treatment retention, patient satisfaction, medication compliance, overall functioning, and engagement in HIV risk behaviors. If warranted by the results, effect sizes from the proposed study will be used to help in the preparation of a larger-scale subsequent Stage II study.