Affect Regulation Training (ART)for Alcohol Use Disorder: A Stage II Efficacy Trial

酒精使用障碍的影响调节训练 (ART)：第二阶段疗效试验

• 批准号: 9905470
• 负责人: Clara Margaret Bradizza
• 金额: $ 49.76万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-20 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9905470
• 关键词: Address; Affect; Affective; Aftercare; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Behavior Therapy; Behavioral Mechanisms; Clinical Trials; Cognitive Therapy; DSM-V; Development; Educational Intervention; Evaluation; Health; Heavy Drinking; Home environment; Individual; Intervention; Life Style; Link; Maintenance; Mediator of activation protein; Modeling; Monitor; Outcome; Outpatients; Participant; Patients; Physiological; Pilot Projects; Process; Randomized; Randomized Clinical Trials; Recommendation; Regulation; Research; Sample Size; Sampling; Substance Use Disorder; Target Populations; Testing; Therapeutic; Training; Treatment outcome; Woman; active control; alcohol abuse therapy; alcohol relapse; alcohol use disorder; base; clinical practice; clinically significant; craving; design; drinking; effective therapy; efficacy study; efficacy trial; emotion regulation; experience; improved; men; mindfulness; negative affect; novel; pilot trial; recruit; satisfaction; skills; social; success; theories; therapy development; treatment effect

 DESCRIPTION (provided by the applicant): Both theory and research suggest that the desire to regulate one's affective experience is an important motive underlying problem alcohol use. Both positive and negative affect are commonly cited reasons for alcohol use and relapse to use following treatment among individuals with an alcohol use disorder (AUD). Although the use of alcohol to regulate affective states may be viewed by the individual as adaptive in the short term, in the long term, drinking to regulate affect can prove to result in a host of negative personal, social and physiological outcomes. However, despite the strong links between affect and drinking, few studies have directly addressed whether interventions that target negative affect positively impact drinking outcomes among men and women with an AUD. In a completed Stage 1a/1b Behavioral Therapies Development study (AA016054), our research team successfully developed (Stage 1a) and conducted an initial evaluation (Stage 1b) of Affect Regulation Training (ART), a 12-session treatment supplement which was combined with standard cognitive-behavioral therapy (CBT) for alcohol use disorders to enhance alcohol treatment outcomes. To our knowledge, this is the first affect regulation intervention specifically developed for use with substance use disorders. This new treatment (ART) was then compared to a Health and Lifestyles control condition (HLS) that was combined with the same CBT for alcohol use disorders. Thus, both the ART and HLS conditions contained the identical CBT for alcohol use disorders component. This design provided a strong initial test of ART's efficacy because ART had to show a treatment benefit beyond that provided by an active, empirically-supported treatment for AUD (i.e., the CBT component of HLS). Study results provided promising empirical support for further developing ART as an enhancement to CBT treatment. Specifically, the study met all of the aims of the Stage 1b pilot study as outlined by Rounsaville et al. (2001): (a) excellent patient acceptance of ART (i.e., treatment retention and satisfaction, strong therapeutic alliance), (b) ability to recruit the target population, (c) feasibility of treament delivery with Master's level therapists in an outpatient setting, (d) clinically significant patien improvement in at least one important outcome domain (i.e., alcohol outcomes), and (e) effect size estimates to be used to determine the sample size for a Stage II clinical trial. For non-drinking outcomes, the results revealed small to moderate effects for several treatment process variables consistent with ART's proposed mechanisms of change (i.e., decreased negative affect, increased mindfulness, increased reappraisal, and increased emotion regulation skills). Given these promising results, we propose to conduct a fully-powered Stage II efficacy trial in which we will compare 12 weekly, individual sessions of ART to the HLS control condition. An important aspect of a Stage II randomized clinical trial is to determine how treatments exert their positive effects. Thus, the proposed study will explore several mechanisms of action by which ART is hypothesized to exert its positive effects on alcohol treatment outcomes. PROJECT NARRITIVE: Despite the strong links between positive and negative affect situations and problem drinking, few studies have directly addressed whether interventions that target affect regulation positively impact drinking outcomes. This study proposes to conduct a fully-powered Stage II efficacy trial to compare our Affect Regulation Treatment (ART) intervention to an active health and lifestyle control and explore mechanisms of action by which ART exerts its positive effects. If successful, the findings from this study are anticipated to have a direct impat on clinical practice by providing the field with a novel, effective treatment for alcohol use disorders that addresses affect regulation difficulties.

 描述（由申请人提供）：理论和研究都表明，调节情感体验的愿望是酒精使用问题的一个重要动机。积极和消极的影响都是酒精使用障碍（AUD）患者治疗后酒精使用和复发的常见原因。虽然使用酒精来调节情感状态在短期内可能被个人视为适应性的，但从长远来看，饮酒来调节情感可能会导致许多负面的个人，社会和生理后果。然而，尽管影响和饮酒之间有很强的联系，但很少有研究直接探讨针对负面影响的干预措施是否会对患有AUD的男性和女性的饮酒结果产生积极影响。在一项已完成的1a/1b期行为疗法开发研究（AA 016054）中，我们的研究团队成功开发（1a期）并对情感调节训练（ART）进行了初步评估（1b期），这是一种12疗程的治疗补充剂，与酒精使用障碍的标准认知行为疗法（CBT）相结合，以增强酒精治疗效果。据我们所知，这是第一次专门影响监管干预 开发用于物质使用障碍。然后将这种新的治疗（ART）与健康和生活方式控制条件（HLS）进行比较，后者与酒精使用障碍的相同CBT相结合。因此，ART和HLS条件都包含相同的酒精使用障碍CBT组分。该设计提供了对ART功效的强有力的初始测试，因为ART必须显示出超过由主动的、药物支持的AUD治疗提供的治疗益处（即，HLS的CBT组件）。研究结果为进一步发展ART作为CBT治疗的增强提供了有希望的经验支持。具体地，该研究满足Rounsaville等人（2001）概述的阶段1b试点研究的所有目标：（a）患者对ART的极好接受（即，治疗保留率和满意度， 强大的治疗联盟），（B）招募目标人群的能力，（c）在门诊环境中用硕士水平的治疗师进行治疗的可行性，（d）在至少一个重要结果领域（即，酒精结果），和（e）用于确定II期临床试验样本量的效应量估计。对于非饮酒结果，结果显示，与ART提出的变化机制一致的几个治疗过程变量的影响较小至中等（即，减少负面影响，增加正念，增加重新评价，增加情绪调节技能）。鉴于这些有希望的结果，我们建议进行一项完全有效的II期疗效试验，其中我们将比较12周一次的单独ART治疗与HLS对照条件。II期随机临床试验的一个重要方面是确定治疗如何发挥其 积极的影响。因此，拟议的研究将探讨几种作用机制，通过这些机制，ART被假设对酒精治疗结果产生积极影响。 项目叙述：尽管积极和消极的影响情况和问题饮酒之间有很强的联系，但很少有研究直接涉及针对影响调节的干预措施是否会对饮酒结果产生积极影响。本研究建议进行一项完全有效的II期疗效试验，将我们的情感调节治疗（ART）干预与积极的健康和生活方式控制进行比较，并探索ART发挥其积极作用的作用机制。如果成功，这项研究的结果预计将对临床实践产生直接影响，为酒精使用障碍提供一种新的有效治疗方法，解决影响调节的困难。