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

一种基于接受的新疗法治疗患有创伤后应激障碍的退伍军人的失眠

• 批准号: 10311382
• 负责人: Jennifer L Martin
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10311382
• 关键词: Address; Adopted; Adoption; Aftercare; Anxiety; Area; Attenuated; Behavior; Behavioral; Clinical; Cognitive; Cognitive Therapy; Combined Modality Therapy; Comorbid Insomnia; Data; Exclusion Criteria; Exercise; Feeling suicidal; Gold; Health; Individual; Intervention; Intervention Studies; Knowledge; Measures; Medicine; Mental Depression; Mental Health; Methodology; Neurobehavioral Manifestations; Outcome; Outcome Measure; Outcome Study; Pathway interactions; Patients; Population; Post-Traumatic Stress Disorders; Process; Process Measure; Provider; Psychotherapy; Quality of life; Randomized; Relaxation; Services; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Specific qualifier value; Stimulus; Symptoms; Techniques; Testing; Therapeutic Intervention; Time; Training; Training Programs; Veterans; Woman; Work; avoidance behavior; base; clinical care; comorbidity; design; diaries; effective therapy; effectiveness evaluation; evidence base; experience; flexibility; follow-up; improved; innovation; interest; mindfulness; novel; poor sleep; post-traumatic symptoms; programs; psychologic; randomized trial; response; sleep health; sleep quality; sound; standard care; therapy design; treatment response; trial design

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.

背景：11-20% 的退伍军人患有创伤后应激障碍 (PTSD)，70-88% 的退伍军人患有创伤后应激障碍 (PTSD) PTSD 伴有失眠障碍。推荐针对失眠的认知行为疗法（CBT-I） 失眠症的一线治疗；然而，对患有 PTSD 的退伍军人使用这种方法 挑战和治疗成果都减弱了。越来越多的证据表明，理论基础 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 与基于证据的行为策略相结合时的睡眠。我们开发了基于 ACT 的失眠疗法 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 的行为组成部分（睡眠限制、刺激控制、睡眠卫生、放松） 技术。我们的初步研究表明 ABC-I 对于患有 PTSD 的退伍军人非常有效。 意义/影响：高达 90% 的 PTSD 患者都经历过睡眠不佳的情况，而且通常不会 通过 PTSD 治疗解决。失眠症与许多负面结果相关，包括 自杀意念增加、健康状况不佳和生活质量低下。当前的研究将解决这一重要问题 通过评估一种新的治疗失眠症的可能益处来解决临床问题 创伤后应激障碍。该提案响应了 HSR&D 心理健康/PTSD 跨领域优先领域。 创新：拟议的项目在多个方面具有创新性。它解决了一个具有挑战性的问题 退伍军人 - 创伤后应激障碍 (PTSD) 背景下的睡眠障碍。 ABC-I 治疗也是创新的，结合了已知的 ACT 是一种有效的行为策略，是一种治疗抑郁和焦虑的循证方法。审判 设计允许同时进行优效性和非劣效性测试，并将导致这种新产品的快速采用 如果它对 PTSD 症状有效并且对于睡眠症状不劣于 CBT-I，则为治疗。 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 PTSD 症状方面的益处（不睡觉时的 PCL-5 评分） 与 CBT-I 相比，在患有 PTSD 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，我将更大程度地减少 PTSD 症状。 具体目标2：评估ABC-I改善失眠症状（ISI评分）和睡眠的有效性 患有 PTSD 和失眠障碍共病的退伍军人的质量（基于日记的睡眠效率、PSQI 评分） 与 CBT-I 相比。假设2，ABC-I在改善失眠症状和改善失眠方面不劣于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 ACT 相关过程和结果测量前后的变化 ABC-I，包括心理灵活性、[经验性回避]、正念、价值观一致的行为、 抑郁、焦虑和生活质量。 探索性目标 4：探索 ABC-I 和 CBT-I 在减少自杀意念方面的潜在益处 患有创伤后应激障碍 (PTSD) 和失眠症的退伍军人。 方法：拟议的研究将解决以下 PICOT 问题：在患有共病的退伍军人中 PTSD 和失眠障碍（人群；n=200 随机），ABC-I（干预）与 CBT 相比如何？ 6 个月内改善失眠、PTSD 症状和 ACT 相关措施（结果）的 I（比较） 随访期？拟议的分析计划将同时解决 ABC-I 相对于 CBT-I 的优越性 改善 PTSD 症状，并且 ABC-I 与 CBT-I 相比在改善失眠症状方面不逊色。 实施/后续步骤：拟议研究的结果将引起多个利益相关者的兴趣， 包括当地睡眠医学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种途径传播。