Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change

 描述（由申请人提供）：大量饮酒（定义为女性/男性每次饮酒4+/5+）和酒精使用障碍（AUD）是一个重大的公共卫生问题。存在对AUD适度有效的药理学和心理社会治疗，但一些重度饮酒（即，复发）是AUD治疗后最常见的结局。因此，显然有必要继续发展创新和有效的干预措施，减少大量饮酒，并专门针对大量饮酒的风险因素。一种新的干预措施，有相当大的希望减少大量饮酒是正念为基础的复发预防（MBRP）。MBRP是一种针对物质使用障碍的行为干预措施，旨在针对渴望和其他大量饮酒的风险因素。基于大量研究的结果，MBRP治疗AUD是可行和有效的。然而，MBRP的效果仍然很小，许多人在治疗的早期就难以进行正念练习。我们的研究小组有初步证据表明，结合非侵入性形式的脑刺激，经颅直流电刺激（tDCS），可以改善正念练习的参与，并导致治疗后大量饮酒的显着减少。拟议研究的目标是检查正念+ tDCS干预在减少大量饮酒和影响有兴趣减少大量饮酒的AUD患者行为改变的假设机制方面的有效性。在拟议的研究中，一个在AUD治疗，正念干预，脑刺激和认知神经科学方面具有互补专业知识的研究团队将通过脑电图（EEG）结合联合收割机自我报告，行为和神经生理数据收集，以研究治疗效果的心理和神经生理机制，然后将脑刺激与正念训练相结合。假设基于正念的干预与主动tDCS相结合，在治疗8周后导致每天饮酒量的显着减少，并且这些减少将在治疗后维持长达2个月。此外，在2个月随访时，活性tDCS对每个饮酒日的饮酒量的影响将通过治疗期间和治疗后评估时更大的正念、更大的抑制控制以及渴望和负面影响的减少来介导。将约86名符合AUD标准的个体随机分配至8个MBRP联合活性tDCS（2.0毫安电流）或MBRP联合假tDCS（0.1毫安电流）对照条件。拟定研究将使用行为测量和EEG（次要目的）检查疗效（主要目的）以及治疗疗效的心理和神经生理机制。除了解决在MBRP中添加活性tDCS是否会增强疗效的问题外，它还将进一步研究神经生理学和行为治疗机制的问题，以更好地为未来大型疗效试验的设计提供信息。

 DESCRIPTION (provided by applicant): Heavy drinking (defined as 4+/5+ drinks per occasion for women/men) and alcohol use disorder (AUD) are a significant public health problem. Modestly effective pharmacological and psychosocial treatments for AUD exist, yet some heavy drinking (i.e., relapse) is the most common outcome following AUD treatment. Continued development of innovative and efficacious interventions that reduce heavy drinking and specifically target risk factors for heavy drinking is thus clearly warranted. One novel intervention that has considerable promise for reducing heavy drinking is mindfulness-based relapse prevention (MBRP). MBRP is a behavioral intervention for substance use disorder that was designed to target experiences of craving and other risk factors for heavy drinking. Based on the results of numerous studies, MBRP is feasible and efficacious in the treatment of AUD. However the effect sizes of MBRP remain small and many individuals struggle with engaging in the mindfulness practices early in treatment. There is preliminary evidence from our research group that combining a non-invasive form of brain stimulation, transcranial direct current stimulation (tDCS), may improve engagement with mindfulness practices and lead to significant reductions in heavy drinking following treatment. The goal of the proposed study is to examine the efficacy of a mindfulness + tDCS intervention in reducing heavy drinking and impacting hypothesized mechanisms of behavior change among individuals with AUD who are interested in reducing their heavy drinking. In the proposed study, a research team with complementary expertise in AUD treatment, mindfulness-based interventions, brain stimulation, and cognitive neuroscience will combine self-report, behavioral, and neurophysiological data collection via electroencephalography (EEG) to study the psychological and neurophysiological mechanisms of treatment efficacy following a novel, promising intervention that combines brain stimulation with mindfulness training. The mindfulness based intervention in combination with active tDCS is hypothesized to lead to significant reductions in drinks per drinking day after 8 weeks of treatment and these reductions will be maintained up to 2 months following treatment. Further, the effect of active tDCS on drinks per drinking day at the 2 month follow- up will be mediated by greater mindfulness, greater inhibitory control and reductions in craving and negative affect during treatment and at the post-treatment assessment. Approximately 86 individuals meeting criteria for AUD will be randomly assigned to 8 sessions of either MBRP combined with active tDCS (2.0 milliamp current) or MBRP combined with a sham tDCS (0.1 milliamp current) control condition. The proposed study will examine the efficacy (Primary Aim) and psychological and neurophysiological mechanisms of treatment efficacy using behavioral measures and EEG (Secondary Aim). In addition to addressing the question of whether adding active tDCS to MBRP enhances efficacy, it will further examine issues of neurophysiological and behavioral treatment mechanisms to better inform the design of a future large efficacy trial.