Development of a Treatment Adherence Program for Bipolar Substance Abusers

描述(由申请人提供)：物质使用障碍和双相情感障碍基本上是同时发生的。物质使用障碍患者发生双相情感障碍的可能性是普通人群的五到八倍。相反，据报道，在双相样本中，物质使用障碍的比率高达60%或更高。这种共病与发病年龄较早、症状严重程度增加、暴力倾向较大、精神科住院率较高、急性情绪发作缓解时间较慢、对锂治疗的反应较差以及自杀和死亡率增加有关。尽管治疗不依从性在物质使用和双相情感障碍中都是一个重要的问题，但这些情况的共同出现与更差的依从率有关。此外，研究表明，与非共病患者相比，双极物质滥用者的病程更差，而不坚持是这些糟糕结果的最一致的预测因素。到目前为止，关于行为干预的研究很少，这些行为干预专门设计来提高这一高危、共病人群的治疗依从性。本提案旨在满足NIDA行为和综合疗法发展计划(PA-07-111)第一阶段的目标。第一阶段是治疗开发研究的初始阶段：制定新的行为疗法；从操作上确定治疗手册和程序；以及试点、测试和改进新疗法。这项研究的总体目标是开发综合治疗依从性计划(ITAP)，旨在作为一种辅助干预措施来改善双相物质滥用者的治疗依从性(广义)，并收集关于该计划的可行性、可接受性和初步疗效的初步数据。更具体地说，我们提出了以下主要目标：1.通过对药物依赖和双相情感障碍患者进行一项小型开放试验(n=15)，为ITAP开发一份全面的治疗手册-一种结合了激励、家庭和电话策略的创新的多模式干预。2.通过将ITAP与常规治疗进行比较，以评估相关治疗参数(如可接受性、初步疗效)，包括HIV危险行为，对60例首次住院的共病物质依赖和双相情感障碍患者进行随机对照初步研究。这项先导性研究将为一项更大的临床试验(第二阶段)奠定基础，评估这种新疗法在改善双极物质滥用者依从性方面的有效性。

DESCRIPTION (provided by applicant): There is a substantial co-occurrence between substance use disorders and bipolar disorder. Bipolar disorder is five to eight times more likely to occur in patients with substance use disorders than in the general population. Conversely, rates of substance use disorders in bipolar samples have been reported to be as high as 60% or more. This comorbidity is associated with an earlier age of illness onset, increased symptom severity, greater tendency for violence, higher rates of psychiatric hospitalization, slower time to remission of acute mood episodes, poorer response to lithium treatment, and increased suicidality and mortality rates. Although treatment nonadherence is a significant problem in both substance use and bipolar disorders independently, the co-occurrence of these conditions is related to even poorer compliance rates. Further, research indicates that bipolar substance abusers have a worse course of illness compared to noncomorbid patients, and nonadherence is the most consistent predictor of these poor outcomes. To date, there is very little research on behavioral interventions specifically designed to improve treatment adherence in this high-risk, comorbid population. The present proposal is designed to meet the objectives of Stage I of the NIDA Behavioral and Integrative Therapies Development Program (PA-07-111). Stage I is the initial stage of treatment development research: to formulate new behavioral therapies; to operationally define therapy manuals and procedures; and to pilot test and refine new therapies. The overall aim of this study is to develop the Integrated Treatment Adherence Program (ITAP), which is designed as an adjunctive intervention for improving treatment adherence (broadly defined) in bipolar substance abusers, and to collect preliminary data on the feasibility, acceptability, and initial efficacy of the program. More specifically, we propose the following major aims: 1. To develop a comprehensive treatment manual for ITAP - an innovative, multi-modal intervention that combines motivational, family, and telephone-based strategies - by conducting a small open trial (n = 15) with patients with drug dependence and bipolar disorder. 2. To conduct a randomized controlled pilot study in a sample (n = 60) of patients initially hospitalized with comorbid substance dependence and bipolar disorder by comparing ITAP to treatment as usual to estimate relevant treatment parameters (e.g., acceptability, preliminary efficacy), including HIV risk behaviors. This pilot study will lay the groundwork for a larger clinical trial (Stage II) evaluating the efficacy of this new treatment for improving adherence in bipolar substance abusers.