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之间存在实质性的共同发生。双相情感障碍在物质使用障碍患者中发生的可能性是一般人群的五到八倍。相反，据报道，双相情感障碍样本中的物质使用障碍率高达60%或更高。这种合并症与发病年龄较早、症状严重程度增加、暴力倾向增加、精神病住院率较高、急性情绪发作缓解时间较慢、锂治疗反应较差以及自杀倾向和死亡率增加有关。虽然治疗不依从性是一个重要的问题，在物质使用和双相情感障碍独立，共同发生的这些条件是相关的，甚至更差的依从率。此外，研究表明，双相情感药物滥用者的病程比非共病患者更差，不依从是这些不良结局的最一致预测因素。到目前为止，很少有研究专门设计的行为干预措施，以提高治疗依从性，在这个高风险，共病人群。本提案旨在满足NIDA行为和综合疗法开发计划（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;操作性地定义治疗手册和程序;以及试点测试和改进新疗法。本研究的总体目标是制定综合治疗依从性计划（ITAP），该计划旨在作为改善双相情感药物滥用者治疗依从性（广义定义）的连续干预措施，并收集有关该计划可行性、可接受性和初始疗效的初步数据。具体而言，我们提出以下主要目标：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制定一份综合治疗手册，ITAP是一种创新的多模式干预措施，结合了激励、家庭和基于电话的策略。2.在最初因共病物质依赖和双相情感障碍住院的患者样本（n = 60）中进行一项随机对照初步研究，通过比较ITAP与常规治疗来估计相关治疗参数（例如，可接受性，初步疗效），包括艾滋病毒的危险行为。这项试点研究将为更大规模的临床试验（第二阶段）奠定基础，以评估这种新的治疗方法在改善双相情感药物滥用者依从性方面的疗效。

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.