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)：酗酒(定义为女性/男性每次饮酒4+/5+)和酒精使用障碍(AUD)是一个严重的公共卫生问题。对AUD有适度有效的药物和心理社会治疗，但一些酗酒(即复发)是AUD治疗后最常见的结果。因此，显然有必要继续开发创新和有效的干预措施，减少酗酒，并特别针对酗酒的风险因素。一种对减少大量饮酒有相当大希望的新干预措施是基于正念的复发预防(MBRP)。MBRP是一种针对物质使用障碍的行为干预，旨在针对酗酒的渴望和其他危险因素的经历。根据大量研究的结果，MBRP治疗AUD是可行和有效的。然而，MBRP的效果规模仍然很小，许多人在治疗的早期就努力从事正念练习。来自我们研究小组的初步证据表明，结合一种非侵入性的大脑刺激形式--经颅直流电刺激(Tdcs)--可能会提高正念练习的参与度，并导致治疗后大量饮酒的显著减少。这项拟议研究的目标是检验正念+tdcs干预在减少大量饮酒方面的有效性，并影响有兴趣减少大量饮酒的AUD患者的行为改变假想机制。在这项拟议的研究中，一个在AUD治疗、基于正念的干预、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(EEG)结合自我报告、行为和神经生理数据收集，以研究在一种将脑刺激与正念训练相结合的新颖、有前景的干预措施后，治疗效果的心理和神经生理机制。基于正念的干预与积极的tDCs相结合，假设在治疗8周后，每天饮酒的数量将显著减少，这些减少将在治疗后2个月保持。此外，在2个月的随访中，活跃的tDCs对每天饮酒的影响将通过更大的正念、更大的抑制控制以及在治疗期间和治疗后评估中减少渴望和负面影响来实现。大约86名符合AUD标准的患者将被随机分配到MBRP与有源tDCS(2.0毫安电流)或MBRP与假tDCS(0.1毫安电流)控制条件相结合的8个疗程中。这项拟议的研究将使用行为测量和EEG(次要目标)来检查疗效(主要目的)以及治疗效果的心理和神经生理机制。除了解决在MBRP中加入活性tDCs是否能提高疗效的问题外，它还将进一步研究神经生理和行为治疗机制的问题，以便更好地为未来的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.