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

 描述(由申请人提供)：理论和研究都表明，控制自己的情感体验的愿望是酒精使用问题背后的一个重要动机。积极和消极的情绪都是酒精使用和酒精使用障碍(AUD)患者在接受治疗后复发的常见原因。尽管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，通过饮酒来调节情感可能会导致一系列负面的个人、社会和生理后果。然而，尽管情感和饮酒之间有很强的联系，但很少有研究直接讨论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。在完成的1a/1b阶段行为疗法发展研究(AA016054)中，我们的研究团队成功开发(1a阶段)并进行了情感调节训练(ART)的初步评估(1b阶段)，这是一种12个疗程的治疗补充，结合标准认知行为疗法(CBT)治疗酒精使用障碍，以提高酒精治疗结果。据我们所知，这是第一个专门影响监管干预的 专为治疗物质使用障碍而开发。然后将这种新的治疗方法(ART)与健康和生活方式控制条件(HLS)进行比较，后者结合相同的CBT治疗酒精使用障碍。因此，ART和HLS条件都包含酒精使用障碍的相同CBT成分。这一设计为抗逆转录病毒治疗的有效性提供了一个强有力的初步测试，因为抗逆转录病毒治疗必须显示出一种有效的、经验性支持的AUD治疗方法(即HLS的CBT成分)所提供的治疗益处。研究结果为进一步开发ART作为CBT治疗的增强手段提供了有希望的经验支持。具体地说，这项研究达到了Rounaville等人概述的1b阶段试点研究的所有目标。(2001)：(A)患者对抗逆转录病毒治疗的接受度极高(即治疗保留率和满意度， (B)招募目标人群的能力，(C)在门诊环境下与硕士水平的治疗师进行治疗的可行性，(D)患者在至少一个重要结果领域(即酒精结果)的临床显著改善，以及(E)用于确定II期临床试验样本量的效应大小估计。对于不饮酒的结果，结果显示了几个与ART提出的改变机制一致的治疗过程变量的轻微到中等的影响(即减少负面情绪、增加正念、增加重新评估和增加情绪调节技能)。鉴于这些有希望的结果，我们建议进行一项完全有效的第二阶段疗效试验，在该试验中，我们将比较每周12次的ART单独疗程与HLS控制条件。第二阶段随机临床试验的一个重要方面是确定治疗方法如何发挥作用 积极的影响。因此，这项拟议的研究将探索ART假想对酒精治疗结果发挥积极作用的几种作用机制。 NARRITIVE项目：尽管积极和消极的情感状况与问题饮酒之间存在密切联系，但很少有研究直接讨论以影响监管为目标的干预措施是否对饮酒结果产生积极影响。这项研究建议进行一项完全有效的第二阶段疗效试验，以比较我们的情绪调节治疗(ART)干预与积极的健康和生活方式控制，并探索ART发挥积极作用的作用机制。如果成功，这项研究的发现预计将对临床实践产生直接影响，为该领域提供一种解决影响调节困难的新颖、有效的酒精使用障碍治疗方法。

 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.