A Novel Acceptance-based Treatment for Insomnia in Veterans with Post-Traumatic Stress Disorder

背景：创伤后应激障碍(PTSD)影响11%-20%的退伍军人，70%-88%的退伍军人患有创伤后应激障碍 创伤后应激障碍伴有失眠障碍。失眠的认知行为疗法(CBT-I)是推荐的 失眠障碍的一线治疗；然而，对患有创伤后应激障碍的退伍军人使用这种方法 挑战和治疗收益被削弱。有越来越多的证据表明， 接受和承诺疗法(ACT)的具体练习提供了一种可行的方法来改善 睡眠与循证行为策略相结合。我们已经开发出一种基于ACT的失眠症 治疗，称为“接受和行为改变治疗失眠(ABC-I)”，它结合了核心 基于ACT的行为组件(睡眠限制、刺激控制、睡眠卫生、放松) 技巧。我们的初步工作表明，ABC-I对患有创伤后应激障碍的退伍军人非常有效。 重要性/影响：高达90%的创伤后应激障碍患者睡眠不佳，通常情况下不会 用创伤后应激障碍治疗来解决。失眠障碍与一系列负面后果有关，包括 自杀意念增加，健康状况差，生活质量低。目前的研究将解决这一重要问题 通过评估一种治疗失眠障碍的新疗法的可能益处来解决临床问题 创伤后应激障碍。该提案是对精神健康/创伤后应激障碍的高铁与研发交叉优先领域的回应。 创新：拟议的项目在几个方面都是创新的。它解决了一个具有挑战性的问题，包括 退伍军人--创伤后应激障碍背景下的睡眠障碍。ABC-I疗法也是创新的，结合了已知的 使用ACT的有效行为策略，这是一种针对抑郁症和焦虑症的循证方法。这场审判 设计允许同时进行优势和非劣势测试，并将导致这一新技术的快速采用 如果对创伤后应激障碍症状有效，对睡眠症状不逊于CBT-I的治疗。 具体目标：拟议的研究有4个具体目标： 具体目标1：评估ABC-I在减少创伤后应激障碍症状(PCL-5评分，无睡眠)方面的益处 项目)与CBT-I相比，患有创伤后应激障碍和失眠障碍的退伍军人中。假设1：ABC- 与CBT-I相比，在治疗后和6个月的随访中，I将导致PTSD症状的更大程度的减少。 具体目标2：评估ABC-I在改善失眠症状(ISI评分)和睡眠方面的有效性 质量(基于日记的睡眠效率，PSQI评分)，在患有创伤后应激障碍和失眠障碍的退伍军人中 与CBT-I相比。假设2，ABC-I在改善失眠症状和改善睡眠方面不逊于CBT-I 治疗后和6个月随访时的睡眠质量。 探索性目标3：确定与ACT相关的过程和结果衡量标准从实施前到实施后的变化 ABC-I，包括心理灵活性，[经验回避]，正念，价值观一致的行为， 抑郁、焦虑和生活质量。 探索目标4：探索ABC-I和CBT-I在以下方面减少自杀意念的潜在好处 患有创伤后应激障碍和失眠障碍的退伍军人。 方法：拟议的研究将解决以下皮科问题：在患有合并症的退伍军人中 创伤后应激障碍和失眠障碍(人群；n=200随机)，ABC-I(干预)与CBT-I相比如何？ I(比较)在改善失眠、创伤后应激障碍症状和ACT相关措施(结果)方面，超过6个月 随访期是多少？拟议的分析计划将同时解决ABC-I相对于CBT-I在以下方面的优势 与CBT-I相比，ABC-I在改善失眠症状方面改善了PTSD症状和非劣性。 执行/下一步：拟议研究的结果将引起多个利益攸关方的兴趣， 包括当地的睡眠药物服务和针对退伍军人睡眠障碍的国家计划。 研究结果将通过退伍军人事务部内外的多个途径传播。

Background: Post-traumatic stress disorder (PTSD) impacts 11-20% of Veterans, and 70-88% of Veterans with PTSD have comorbid insomnia disorder. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder; however, using this approach with Veterans who have PTSD presents challenges and treatment gains are attenuated. There is emerging evidence that the theoretical underpinning and specific exercises of Acceptance and Commitment Therapy (ACT) present a viable approach to improving sleep when combined with evidence-based behavioral strategies. We have developed an ACT-based insomnia treatment, called "Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I)," which combines core behavioral components (sleep restriction, stimulus control, sleep hygiene, relaxation) with ACT-based techniques. Our preliminary work suggests ABC-I is highly effective for Veterans with PTSD. Significance/Impact: Poor sleep is experienced by up to 90% of individuals with PTSD, and typically does not resolve with PTSD treatment. Insomnia disorder is associated with a host of negative outcomes, including increased suicidal ideation, poor health and low quality of life. The current study will address this important clinical issue by evaluating the possible benefits of a novel treatment for insomnia disorder that is comorbid with PTSD. The proposal is responsive to the HSR&D Cross-Cutting Priority Area of Mental Health/PTSD. Innovation: The proposed project is innovative in several ways. It addresses a challenging issue among Veterans - sleep disturbance in the context of PTSD. ABC-I treatment is also innovative, combining known effective behavioral strategies with ACT, an evidence-based approach for depression and anxiety. The trial design allows for simultaneous superiority and non-inferiority testing and will lead to rapid adoption of this new treatment if it is effective for PTSD symptoms and non-inferior to CBT-I for sleep symptoms. Specific Aims: The proposed study has 4 specific aims: Specific Aim 1: Evaluate the benefits of ABC-I in reducing PTSD symptoms (PCL-5 score without sleep item) among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Hypothesis 1: ABC- I will result in greater reduction of PTSD symptoms compared to CBT-I at post-treatment and 6-month follow-up. Specific Aim 2: Evaluate the effectiveness of ABC-I in improving insomnia symptoms (ISI score) and sleep quality (diary-based sleep efficiency, PSQI score), among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Hypothesis 2, ABC-I will be non-inferior to CBT-I in improving insomnia symptoms and sleep quality, at post-treatment and 6-month follow-up. Exploratory Aim 3: Determine changes in ACT-related process and outcome measures from before to after ABC-I, including psychological flexibility, [experiential avoidance], mindfulness, value-consistent behavior, depression, anxiety and quality of life. Exploratory Aim 4: Explore the potential benefits of ABC-I and CBT-I in reducing suicidal ideation among Veterans with comorbid PTSD and insomnia disorder. Methodology: The proposed study will address the following PICOT question: Among Veterans with comorbid PTSD and Insomnia Disorder (population; n=200 randomized), how does ABC-I (intervention) compare to CBT- I (comparisons) in improving insomnia, PTSD symptoms and ACT-related measures (outcomes), over a 6-month follow-up period? The proposed analytic plan will simultaneously address superiority of ABC-I over CBT-I for improving PTSD symptoms and non-inferiority of ABC-I compared to CBT-I for improving insomnia symptoms. Implementation/Next Steps: The outcomes of the proposed study will be of interest to multiple stakeholders, including local sleep medicine services and the national programs targeting sleep disorders among Veterans. Findings will be disseminated across multiple pathways within and beyond VA.