Behavioral Activation and HIV Risk Reduction for MSM with Crystal Meth Abuse

描述（由申请人提供）：甲基安非他命（“冰毒”）使用问题是男男性接触者中普遍存在且难以治疗的问题，与HIV性风险行为高度相关。这是一项进行行为干预的试点随机对照试验（RCT）的申请，以减少滥用/依赖冰毒的MSM高危性行为，他们有感染艾滋病毒的风险。干预措施结合了最先进的行为风险降低咨询和行为激活疗法（BAT），以帮助参与者重新参与不涉及药物的愉快和有意义的生活活动。行为激活是一种基于证据的抑郁症治疗方法，其重点是帮助个人重新参与产生掌控感和愉悦感的活动。我们为滥用冰毒的男男性接触者选择了这个策略，因为我们的形成性研究显示，滥用冰毒的男男性接触者报告说，由于持续使用冰毒，他们无法享受以前喜欢的活动。在不涉及冰毒使用或性行为的活动中缺乏乐趣（快感缺乏症）导致继续使用冰毒和可能不安全的性行为。干预方法是通过nida资助的R03开发和试点的，拟议的试点RCT是测试该方法的下一个合乎逻辑的步骤。概述：在我们之前的R03的基础上，这是一项针对有冰毒滥用/依赖的男男性接触者的BAT和HIV风险降低咨询的两组试验RCT。概念模型：概念模型关注持续使用冰毒导致的快感缺乏（对以前喜欢的活动失去兴趣）。因此，对于滥用冰毒的人来说，吸毒成为获得快乐的主要手段（或唯一手段）。我们假设，以降低性风险和通过BAT增加安全、愉悦的目标导向活动为目标的干预将有助于提高干预效果，从而减少无保护的性行为和冰毒的使用。假设的作用机制是，行为激活将使参与者重新参与愉快的非药物使用活动（例如，在使用冰毒之前令人愉快的兴趣或爱好），这将作为功能性行为的自然强化，通过体验愉悦和控制的增加来改善不使用冰毒时的抑郁情绪，并减少总体痛苦，因此滥用冰毒的男男性行为者可以更好地从减少艾滋病毒风险的咨询中获益。研究计划概述：未感染艾滋病毒并符合DSM-IV诊断冰毒（安非他明）滥用/依赖标准的男男性行为者将被随机分组。两部分包括(1)“BAT-RR”，行为激活治疗和风险降低咨询，持续10个疗程；与(2)比较条件下，等效风险降低咨询只进行2次。随机分组后，参与者将被随访6个月。主要结局包括性风险（主要）和使用冰毒（次要）。其他次要结果包括愉快（但安全）活动的增加，艾滋病毒信息的增加，性安全和行为技能的动机的增加，抑郁症状严重程度的降低以及多种物质使用的减少。

DESCRIPTION (provided by applicant): Problematic crystal methamphetamine ("meth") use is a prevalent and treatment refractory problem in MSM, and highly associated with HIV sexual risk behavior. This is an application to conduct a pilot randomized controlled trial (RCT) of a behavioral intervention to reduce high risk sex in MSM with meth abuse/dependence who are at risk for HIV acquisition. The intervention incorporates state of the art behavioral risk reduction counseling with behavioral activation therapy (BAT) to help participants re-engage in enjoyable and meaningful life activities not involving drugs. Behavioral activation is an evidence-based treatment for depression that focuses on helping individuals reengage in activities that generate feelings of mastery and pleasure. We chose this strategy for MSM who abuse meth because our formative work revealed that MSM who abuse meth report becoming unable to enjoy activities that they previously enjoyed as a result of ongoing meth use. This lack of enjoyment (anhedonia) in activities that do not involve meth use or sex contributes to the continued use of meth and potentially unsafe sex. The intervention approach was developed and piloted through a NIDA-funded R03, and the proposed pilot RCT is the next logical step in testing this approach. Overview: Building on our prior R03, this is a two-arm pilot RCT of BAT and HIV risk reduction counseling for MSM with meth abuse/dependence. Conceptual Model: The conceptual model focuses on anhedonia (a loss of interest in previously enjoyed activities) as a consequence of continued meth use. Accordingly, for individuals who abuse meth, drug use becomes the central means for (or the only means for) obtaining enjoyment. We hypothesize that an intervention targeting both sexual risk reduction and increasing safe, pleasurable goal-directed activities via BAT will contribute to increased intervention efficacy and, thus, reductions in unprotected sex and meth use. The hypothesized mechanism of action is that behavioral activation will re-engage participants in pleasurable non-drug use activities (e.g., interests or hobbies that were enjoyable before meth use) that will serve as a natural reinforcement for functional behavior, improve depressed mood when not on meth by experiencing increases in pleasure and mastery, and decrease overall distress so that MSM who abuse meth can better benefit from HIV risk reduction counseling. Research Plan Overview: MSM who are HIV-uninfected and meet DSM-IV criteria for a diagnosis of meth (amphetamine) abuse/dependence will be randomized. The two arms include (1) "BAT-RR", behavioral activation therapy and risk reduction counseling which lasts 10 sessions; and (2) the comparison condition, the equivalent risk reduction counseling only for 2 sessions. Participants will be followed for 6 months post-randomization. Main outcomes include sexual risk (primary) and meth use (secondary). Additional secondary outcomes include increases in pleasurable (but safe) activities, increases in HIV information, motivation re: sexual safety, and behavioral skills, decreases in depressive symptoms severity, and decreases in polysubstance use. PUBLIC HEALTH RELEVANCE: Problematic crystal meth use is a prevalent and treatment resistant-problem in men who have sex with men (MSM) domestically, and is highly associated with HIV risk behavior and HIV infection. The present study aims to test a novel treatment for crystal meth use in MSM, incorporating behavioral activation therapy with HIV risk reduction counseling. This approach may be more potent than traditional drug abuse counseling as our preliminary data suggest that MSM who abuse crystal have stopped receiving pleasure from previously enjoyed activities, and behavioral activation therapy involves re-engaging participants in functional and enjoyable activities. If the current RCT pilot is effective at reducing HIV acquisition risk behavior and crystal meth use, in the next grant (NIDA R01) we will work on a combined dissemination and efficacy study- conducting the intervention in drug abuse treatment clinics for MSM, and delivered by drug abuse counselors.