OBJECTIVES:To describe the protocol of a randomized controlled trial to evaluate the effectiveness and mechanisms of three behavioral interventions. METHODS:Participants will include up to 343 Veterans with chronic pain due to a broad range of etiologies, randomly assigned to one of three 8-week manualized in-person group treatments: (1) Hypnosis (HYP), (2) Mindfulness Meditation (MM), or (3) Education Control (EDU). PROJECTED OUTCOMES:The primary aim of the study is to compare the effectiveness of HYP and MM to EDU on average pain intensity measured pre- and post-treatment. Additional study aims will explore the effectiveness of HYP and MM compared to EDU on secondary outcomes (i.e., pain interference, sleep, depression, anxiety and PTSD), and the maintenance of effects at 3- and 6-months post-treatment. Participants will have electroencephalogram (EEG) assessments at pre- and post-treatment to determine if the power of specific brain oscillations moderate the effectiveness of HYP and MM (Study Aim 2) and examine brain oscillations as possible mediators of treatment effects (exploratory aim). Additional planned exploratory analyses will be performed to identify possible treatment mediators (i.e., pain acceptance, catastrophizing, mindfulness) and moderators (e.g., hypnotizability, treatment expectations, pain type, cognitive function). SETTING:The study treatments will be administered at a large Veterans Affairs Medical Center in the northwest United States. The treatments will be integrated within clinical infrastructure and delivered by licensed and credentialed health care professionals.

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目的:描述一项随机对照试验的方案,以评估三种行为干预的有效性和机制。
方法:参加者将包括多达343名因病因广泛而患有慢性疼痛的退伍军人,并随机分配给三种8周的手动面对面小组治疗之一:(1)催眠(HYP),(2)正念冥想( MM),或(3)教育控制(EDU)。
预期结果:该研究的主要目的是比较HYP和MM与EDU在治疗前后平均疼痛强度上的有效性。额外的研究目标将探讨与EDU相比,HYP和MM在继发结局(即疼痛干扰,睡眠,抑郁,焦虑和PTSD)以及治疗后3个月和6个月维持效果方面的有效性。参与者将在治疗前和治疗后进行脑电图(EEG)评估,以确定特定脑部振荡的力量是否会减弱HYP和MM的有效性(研究目标2),并检查脑部振荡可能是治疗效果的中介物(探索性目标) 。将进行其他计划的探索性分析,以识别可能的治疗介体(例如,疼痛接受,灾难性,正念)和调节者(例如,催眠作用,治疗预期,疼痛类型,认知功能)。
地点:研究治疗药物将在美国西北部的大型退伍军人事务医疗中心进行。这些治疗将被整合到临床基础设施中,并由获得执照和认证的医疗保健专业人员提供。

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