Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans with Psychosis

失眠认知行为疗法 (CBT-I) 可改善患有精神病的退伍军人的功能结果

• 批准号: 10663788
• 负责人: Elizabeth A Klingaman
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663788
• 关键词: Acceleration; Address; Affect; Aftercare; Area; Behavioral; Caring; Chronic; Chronic Insomnia; Cladribine; Clinical; Cognitive; Cognitive Therapy; Complex; Consensus; Data; Development; Distress; Effectiveness; Emotional; Feedback; Funding; Guidelines; Health Services Accessibility; Health Surveys; Healthcare; Healthcare Systems; Impairment; Inequity; Internet; Intervention; Letters; Manuals; Maryland; Mediating; Mediation; Medical; Medical center; Mental Health; Mental Health Services; Mental disorders; Methods; Modeling; Outcome; Outcome Measure; Participant; Persons; Pharmaceutical Preparations; Philadelphia; Population; Process; Provider; Psychoses; Psychotherapy; Psychotic Disorders; Quality of life; Randomized, Controlled Trials; Recovery; Recovery of Function; Rehabilitation therapy; Reporting; Research; Research Priority; Research Support; Resolution; Resources; Severities; Severity of illness; Site; Sleep; Sleep disturbances; Sleeplessness; Social Functioning; Suicide attempt; Symptoms; System; Testing; Training; Translating; Veterans; Veterans Health Administration; Visit; Work; World Health Organization Disability Assessment Schedule; Wrist; actigraphy; active control; clinical practice; cognitive function; cognitive recovery; cost; daily functioning; disability; efficacy evaluation; emotional functioning; evidence base; experience; follow up assessment; follow-up; functional disability; functional improvement; functional outcomes; handbook; health related quality of life; improved; improved outcome; improvement on sleep; indexing; lifetime risk; military veteran; physical conditioning; primary outcome; psychiatric symptom; psychosocial; psychotic symptoms; secondary outcome; severe mental illness; side effect; standard care; standard of care; treatment effect; trial comparing

Anticipated Impacts on Veteran’s Healthcare: Insomnia is a critical obstacle to the rehabilitation and functional recovery of Veterans with psychotic disorders. The Veterans Health Administration (VHA) has made treatment of insomnia a high priority; and has initiated a nationwide dissemination of Cognitive Behavioral Therapy for Insomnia (CBT-I)–an evidence-based psychotherapy and the first-line standard of care for insomnia–across the VHA system. However, there are many challenges to treating insomnia in people with psychosis; and as a result, they are rarely treated with CBT-I. As part of my CDA-2, I developed guidelines to tailor CBT-I to address each of these challenges. I have piloted CBT-I delivered with these guidelines and have found that it is feasible, acceptable, and shows preliminary efficacy. A larger, fully powered trial is needed to evaluate efficacy of CBT-I delivered with these guidelines on insomnia and functioning of Veterans with psychosis. If CBT-I tailored for psychosis is effective, these guidelines will be incorporated into the national VA CBT-I manual and training materials. Thereby, immediately translating research into clinical practice for maximal functional impact. This project will allow us to evaluate insomnia as a target for accelerating rehabilitation and provide clarity as to whether this population—one of the most severely impaired and costly groups of Veterans—can experience long-term functional benefits from bettersleep. Project Background: Insomnia affects an alarming number of Veterans with psychotic disorders; causes significant long-term negative impacts on physical, emotional, psychosocial, and cognitive recovery; aggravates psychotic symptoms; and confers a nearly 15-fold increase in lifetime risk for attempting suicide. Among people with other chronic medical and mental health conditions, randomized controlled trials (RCTs) demonstrate that successful insomnia treatment can lead to significantly: improved sleep, cognitive, social, and daily functioning, psychiatric symptoms, and health-related quality of life. However, Veterans with psychosis are rarely offered CBT-I, the current gold standard treatment for insomnia, due to a lack of empirically driven clinical guidelines that can assist providers in its delivery with this complex population. Veterans with psychosis deserve access to the same treatments that are available to other Veterans; this inequity in delivery of insomnia treatment must be addressed. Project Objectives: The proposed research will evaluate the efficacy of CBT-I delivered with guidelines for psychosis on improving sleep and associated functional outcomes in Veterans with psychosis and insomnia via a large-scale multi-site randomized control trial (RCT) comparing 10 weeks of CBT-I (n=78) to 10 weeks of an active control intervention (n=78) on insomnia symptoms and functioning. In addition, we will assess the durability of effects of CBT-I on insomnia symptoms and functioning at a 6-month follow-up visit. We expect that Veterans in CBT-I will evidence a greater reduction in insomnia symptoms and improvement in functioning at immediate post-treatment and at 6 months post-treatment. Finally, to understand the ways that Veterans with psychosis are impacted by resolution of chronic insomnia; we will also examine how improvements in insomnia severity mediate functional change at both post-treatment and 6-month follow-upassessments. Project Methods: This project includes completing an RCT with 156 participants at the VA Maryland Health Care System and Corporal Michael J. Crescenz VA Medical Center in Philadelphia. Primary outcome measures include the Insomnia Severity Index and Veterans RAND 36-Item Health Survey. Secondary outcome measures include wrist actigraphy, Consensus Sleep Log-Core, and World Health Organization Disability Assessment Schedule. All participants will complete assessments at baseline, post-treatment, and 6 months post- treatment, with primary outcome measures also administered mid-treatment at week 5 for mediation analysis. Tests of treatment effects on the outcomes will be performed with linear mixed effects models.

对退伍军人医疗保健的预期影响：失眠是康复和康复的一个关键障碍 退伍军人健康管理局 (VHA) 已制定了患有精神障碍的退伍军人的功能恢复。 失眠治疗成为当务之急；并已在全国范围内推广认知行为疗法； 失眠疗法 (CBT-I)——一种基于证据的心理疗法和一线护理标准 失眠——整个 VHA 系统 然而，治疗失眠患者面临许多挑战。 作为我的 CDA-2 的一部分，我制定了指导方针来治疗他们。 定制 CBT-I 来应对这些挑战，我已经按照这些指导方针进行了试点 CBT-I。 已经发现这是可能的，可以接受的，并且显示出初步的功效。 需要评估根据这些指南提供的 CBT-I 对退伍军人失眠和功能的疗效 如果针对精神病量身定制的 CBT-I 有效，这些指南将被纳入 国家 VA CBT-I 手册和培训材料，从而立即将研究转化为临床。 该项目将使我们能够将失眠作为加速目标进行评估。 康复并明确这一人群是否是受损最严重、成本最高的群体之一 退伍军人——可以从更好的睡眠中体验到长期的功能益处。 项目背景：失眠影响着数量惊人的患有精神障碍的退伍军人； 对身体、情感、心理和认知恢复产生重大的长期负面影响； 加重精神病症状；并使终生尝试自杀的风险增加近 15 倍。 在患有其他慢性疾病和心理健康问题的人群中，随机对照试验 (RCT) 证明成功的失眠治疗可以显着改善睡眠、认知、社交、 然而，退伍军人的日常功能、精神症状和健康相关的生活质量。 精神病患者很少接受 CBT-I（目前治疗失眠的金标准），因为缺乏 经验驱动的临床指南可以帮助提供者针对这一复杂人群提供治疗。 患有精神病的退伍军人应该获得与其他退伍军人相同的治疗； 必须解决失眠治疗中的不平等问题。 项目目标：拟议的研究将评估 CBT-I 的有效性，并提供指导方针 精神病对改善患有精神病和失眠的退伍军人的睡眠和相关功能结果的影响 一项大规模多中心随机对照试验 (RCT)，将 10 周的 CBT-I (n=78) 与 10 周的 CBT-I (n=78) 进行比较 此外，我们还将评估失眠症状和功能的主动控制干预（n=78）。 我们预计 CBT-I 对失眠症状和功能的影响在 6 个月的随访中具有持久性。 参加 CBT-I 的退伍军人将证明失眠症状得到更大程度的减少，功能得到改善 最后，了解退伍军人的治疗方式。 慢性失眠的缓解对精神病患者的影响如何；我们还将研究如何改善 失眠严重程度介导治疗后和 6 个月随访评估的功能变化。 项目方法：该项目包括一项由 VA 马里兰健康中心 156 名参与者参与的完整随机对照试验 护理系统和费城退伍军人管理局医疗中心 Michael J. Crescenz 下士主要结果指标。 包括失眠严重程度指数和退伍军人兰德 36 项健康调查次要结果指标。 包括腕部活动记录仪、共识睡眠日志核心和世界卫生组织残疾评估 时间表 所有参与者将在基线、治疗后和治疗后 6 个月完成评估。 治疗，主要结果指标也在治疗中期第 5 周进行调解 将使用线性混合效应模型来测试治疗对结果的影响。