Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States of America; Ralph H Johnson Veterans Administration Medical Center, Charleston, SC, United States of America.
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States of America.
Contemp Clin Trials. 2021 Jun;105:106393. doi: 10.1016/j.cct.2021.106393. Epub 2021 Apr 20.
Mindfulness based interventions have been shown to be efficacious in treating depression, anxiety, pain and substance use disorders (SUDs). Mindfulness-Based Relapse Prevention (MBRP) is an intervention that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, in an 8-week, manualized group intervention designed to treat SUDs by helping patients regulate negative emotional states and reactive behavior. This paper describes the rationale, study design and methodology of a two-site, randomized controlled trial comparing MBRP to 12-Step Facilitation (TSF) in military Veterans following completion of intensive outpatient treatment for SUDs. The 8 weeks of 90-min, group-based MBRP or TSF sessions are followed by 3-, 6- and 10-month follow-up period with assessments of alcohol/drug use, quality of life, depression, anxiety, mindfulness and other functional outcomes, such as employment. The primary hypothesis is that MBRP will be significantly better than TSF in promoting recovery and prevention of relapse to substance use in a military Veteran population. The secondary hypothesis is that MBRP will lead to greater improvements in quality of life, depression/anxiety, and functional outcomes, such as employment. This study is designed to provide information about the use of group-based MBRP as a relapse prevention strategy for military Veterans who have completed an intensive SUD clinical treatment program. Clinical Trial Identifier: NCT02326363.
正念干预已被证明在治疗抑郁、焦虑、疼痛和物质使用障碍（SUD）方面有效。基于正念的复发预防（MBRP）是一种干预措施，它将认知行为复发预防和正念冥想练习结合在一起，在一个为期 8 周、手册化的小组干预中，旨在通过帮助患者调节负面情绪状态和反应性行为来治疗 SUD。本文描述了一项两地点、随机对照试验的基本原理、研究设计和方法，该试验比较了 MBRP 与 12 步促进（TSF）在完成 SUD 强化门诊治疗后的退伍军人中的效果。8 周的 90 分钟、基于小组的 MBRP 或 TSF 课程结束后，将进行 3、6 和 10 个月的随访，评估酒精/药物使用、生活质量、抑郁、焦虑、正念和其他功能结果，如就业。主要假设是 MBRP 将在促进康复和预防退伍军人物质使用复发方面明显优于 TSF。次要假设是 MBRP 将导致生活质量、抑郁/焦虑和功能结果（如就业）的更大改善。这项研究旨在提供关于使用基于小组的 MBRP 作为完成强化 SUD 临床治疗方案的退伍军人的复发预防策略的信息。临床试验标识符：NCT02326363。
