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 潜在的饮酒问题。积极和消极的影响都是人们普遍认为的饮酒原因。 酒精使用障碍 (AUD) 患者治疗后复发。 使用酒精来调节情感状态可能会被个人视为短期内的适应性。 从长远来看，通过饮酒来调节情绪可能会导致一系列负面的个人、社会和生理问题 然而，尽管情感与饮酒之间存在密切联系，但很少有研究直接解决这一问题。 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 在已完成的 1a/1b 阶段行为疗法开发研究 (AA016054) 中，我们的研究 团队成功开发（第 1a 阶段）并进行了影响调节的初步评估（第 1b 阶段） 培训 (ART)，一种 12 疗程的治疗补充，与标准认知行为相结合 据我们所知，这是针对酒精使用障碍的疗法（CBT），以增强酒精治疗效果。 首先是专门针对药物滥用障碍而开发的影响调节干预措施。 然后将治疗（ART）与健康和生活方式控制条件（HLS）进行比较，并结合 相同的 CBT 酒精使用障碍 因此，ART 和 HLS 条件都包含相同的 CBT。 该设计为 ART 的功效提供了强有力的初步测试，因为 ART 必须显示出治疗益处超出了针对 AUD 的积极、经验支持的治疗所提供的治疗益处 （即 HLS 的 CBT 部分）研究结果为进一步发展提供了有希望的实证支持。 ART 作为 CBT 治疗的增强具体而言，该研究满足了 1b 阶段试点的所有目标。 Rousaville 等人 (2001) 概述的研究：(a) 患者对 ART 的接受度很高（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）可行性 在门诊接受硕士学位治疗师的治疗，(d) 有临床意义的患者 至少一个重要结果领域（即酒精结果）的改善，以及 (e) 效应大小估计 用于确定 II 期临床试验的样本量 对于非饮酒结果，结果。 揭示了与 ART 提议一致的几个治疗过程变量的小到中度影响 改变的机制（即减少负面影响、增加正念、增加重新评估和 提高情绪调节技能）鉴于这些有希望的结果，我们建议进行一次全面的研究。 II 期疗效试验，我们将每周 12 次单独的 ART 疗程与 HLS 对照进行比较 II 期随机临床试验的一个重要方面是确定治疗如何发挥作用。 因此，拟议的研究将探讨 ART 的几种作用机制。 饮食对酒精治疗结果发挥积极作用。