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: 10224418
• 负责人: Clara Margaret Bradizza
• 金额: $ 11.74万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10224418
• 关键词: Address; Affect; Affective; Alcohol abuse; Alcohol consumption; Alcohols; Behavior Therapy; Clinical Trials; Cognitive Therapy; Evaluation; Health; Individual; Intervention; Life Style; Link; Outcome; Outpatients; Patients; Physiological; Pilot Projects; Process; Randomized Clinical Trials; Regulation; Research; Sample Size; Substance Use Disorder; Target Populations; Testing; Therapeutic; Training; Treatment outcome; Woman; alcohol abuse therapy; alcohol relapse; alcohol use disorder; clinical practice; clinically significant; design; drinking; effective therapy; efficacy trial; emotion regulation; experience; men; mindfulness; negative affect; novel; recruit; satisfaction; skills; social; theories; therapy development

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 treatment delivery with Master’s level therapists in an outpatient setting, (d) clinically significant patient 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.

理论和研究都表明，调节情感体验的愿望是一个重要的动机 潜在的酒精使用问题。积极的和消极的情绪都是饮酒的常见理由 并在酒精使用障碍(AUD)患者的治疗后复发使用。尽管 使用酒精来调节情感状态在短期内可能被个体视为适应性的，在 从长远来看，饮酒来调节情绪可能会导致一系列负面的个人、社会和生理方面的问题 结果。然而，尽管情感和饮酒之间有很强的联系，但很少有研究直接涉及 针对负面影响的干预措施是否会对男性和女性的饮酒结果产生积极影响 有澳元的。在已完成的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(阶段1a)并进行了初步评估(阶段1b)的影响规则 培训(ART)，12个疗程的补充治疗，结合标准认知行为 酒精使用障碍的治疗(CBT)以提高酒精治疗的结果。据我们所知，这是 第一，专门为治疗物质使用障碍而开发的情感调节干预。这是一项新的 然后将治疗(ART)与健康和生活方式控制条件(HLS)进行比较，HLS与 同样的CBT也适用于酒精使用障碍。因此，ART和HLS条件都包含相同的CBT 用于酒精使用障碍的成分。这一设计为ART的有效性提供了一个强有力的初步测试，因为ART 必须显示出比积极的、经验性支持的澳门氏症治疗方法所提供的治疗益处 (即，HLS的CBT组件)。研究结果为进一步发展提供了良好的经验支持 ART作为CBT治疗的增强。具体地说，这项研究达到了1b阶段试点的所有目标。 Rounaville等人概述的研究。(2001)：(A)患者对抗逆转录病毒治疗的接受度极高(即治疗保留 和满意度、强大的治疗联盟)、(B)招募目标人群的能力、(C) 在门诊环境中使用硕士级别的治疗师提供治疗，(D)临床重要患者 至少一个重要结果领域(即酒精结果)的改善，以及(E)效果大小估计 用于确定II期临床试验的样本量。对于不饮酒的结果，结果是 对几个处理过程变量显示出与ART建议的一致的小到中等影响 改变的机制(即，减少负面影响，增加正念，增加重新评估，以及 提高情绪调节技能)。鉴于这些可喜的结果，我们建议进行一次全面的 第二阶段疗效试验，我们将对每周12次的抗逆转录病毒疗法与HLS对照组进行比较 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的几种作用机制 假设会对酒精治疗结果产生积极影响。