A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans

比较简单和标准认知行为疗法治疗退伍军人失眠的随机临床试验

• 批准号: 10534886
• 负责人: HENRY John ORFF
• 金额: --
• 依托单位: VA SAN DIEGO 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: 2022-11-01 至 2026-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534886
• 关键词: Address; Aftercare; Alcohols; Alzheimer' s Disease; Area; Beds; Behavioral; Bipolar Disorder; Caring; Characteristics; Chronic; Chronic Insomnia; Clinic; Clinical; Cognitive Therapy; Columbidae; Cross-Sectional Studies; Depressive disorder; Development; Diagnosis; Disease; Dissemination and Implementation; Distress; Drug Use Disorder; Education; Enrollment; Equation; Equipment and supply inventories; Evolution; Failure; Feeling suicidal; Fingers; Freedom; Generalized Anxiety Disorder; Goals; Health; Healthcare Systems; Hour; Hybrids; Impairment; Investigation; Left; Measures; Mediating; Medicine; Mental Depression; Mental Health; Mental disorders; Modeling; Modification; Observational Study; Occupational; Outcome; Outcome Measure; Pain; Participant; Patients; Persons; Phenotype; Population; Post-Traumatic Stress Disorders; Prevalence; Primary Care; Quality of life; Questionnaires; Randomized; Rehabilitation Outcome; Relaxation Techniques; Reporting; Resources; Risk; Sampling; Selection for Treatments; Severities; Site; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleep disturbances; Sleeplessness; Specialist; Stimulus; Suicide; Technology; Telemedicine; Testing; Time; United States Department of Veterans Affairs; Variant; Veterans; Veterans Health Administration; World Health Organization Disability Assessment Schedule; anxiety symptoms; awake; brief intervention; care seeking; clinical practice; clinically significant; comparative effectiveness; dual diagnosis; falls; follow up assessment; follow-up; functional disability; functional outcomes; high risk; improved; indexing; multi-component intervention; operation; personalized medicine; physical conditioning; physically handicapped; psychosocial; randomized, clinical trials; recruit; secondary analysis; sex; sleep health; social; standard care; success; suicidal; symptomatology; timeline; treatment effect; treatment optimization; trial comparing; unhealthy lifestyle

Veterans seen in VA primary care and mental health clinics commonly present with complaints of sleep disturbance, especially insomnia. For example, in a cross-sectional study examining sleep disorders among Veterans seeking care through the Veterans Health Administration between 2000-2010, sleep apnea (47%) and insomnia (26%) were the most commonly diagnosed conditions. In a study of 375 Operation Enduring Freedom/Operation Iraqi Freedom Veterans, 45% reported extended time spent trying to fall asleep (> 30 minutes), 21% reported reduced total sleep times (< 4.5 hours), and 56% reported being awake in bed more than 15% of the night. Similarly, in another observational study of 5,552 Veterans, 57.2% of the sample population was found to have insomnia disorder. This sample also was at high-risk for a host of clinical disorders, including PTSD, TBI, and pain; all of which showed higher rates of insomnia. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a multi-component intervention that features sleep restriction, stimulus control, sleep hygiene education, cognitive therapy, and can include relaxation techniques. CBT-I is recognized as the first-line treatment for chronic insomnia and is effective in Veterans, however, limitations to use still remain. In recent years advances in treatment approaches have attempted to streamline CBT-I by focusing on delivery of specific treatment components, reducing number of treatment sessions, and/or use of technologies that provide for ease of dissemination and implementation. Brief Cognitive-Behavioral Therapy for Insomnia (bCBT-I) represents one such empirically tested brief intervention which may decrease patient burden through reduced sessions needed to achieve treatment goals and through use of hybrid treatment administration (i.e., in-person and telemedicine). To better inform both clinical practice and future research, this investigation proposes to assess the comparative effectiveness of bCBT-I to VA standard CBT-, with several overarching goals: 1) in a randomized clinical trial (RCT), evaluate the equivalence (non-inferiority) of bCBT-I to VA standard CBT-I; 2) evaluate the impact of these treatment approaches on functional rehabilitation outcomes; 3) evaluate the impact of these treatment approaches on psychiatric symptomatology; and 4) in an exploratory fashion, determine which patient factors best predict success or failure with a given treatment as a means of developing insomnia phenotypes that might be used diagnostically to match patient characteristics and type of treatment to help optimize clinical outcomes (i.e., a “personalized medicine” approach to treatment). The investigation timeline consists of four parts: 1) baseline assessment of sleep, functional, and psychiatric outcome measures; 2) randomization and assignment to either CBT-I or bCBT-I; 3) post-treatment assessment; and 4) 3-month follow-up assessment. Over 40 months of recruitment this study will enroll and randomize 180 Veterans on a 1:1 ratio (CBT-I:bCBT-I= 90:90) from VA primary care and mental health clinics at two Centers of Excellence sites (VA San Diego Healthcare System and Finger Lakes VAMC Healthcare System). For the primary study aim, one-sided mean difference testing will be conducted with the noninferiority margin added to the null value. Secondary analyses will utilize structural equation modeling to evaluate how CBT-I and bCBT-I influence functional and psychosocial outcomes. The Exploratory aim will utilize moderation analyses to better understand for whom either CBT-I and/or bCBT-I might be more effective.

在VA初级保健和心理健康诊所中看到的退伍军人通常会出现睡眠的抱怨 干扰，尤其是失眠。例如，在一项横断面研究中，研究了睡眠障碍 退伍军人在2000 - 2010年之间通过退伍军人卫生管理局寻求护理，睡眠呼吸暂停（47％）和 失眠（26％）是最常见的疾病。在研究375操作的研究中 自由/行动伊拉克自由退伍军人，有45％的人报告了长时间试图入睡的时间（> 30 分钟），21％的人报告总睡眠时间减少（<4.5小时），而56％的人报告说醒着更多 夜晚的15％。同样，在另一项对5,552名退伍军人的观察性研究中，其中57.2％ 发现人口患有失眠症。该样本还处于高风险的临床疾病中， 包括PTSD，TBI和疼痛；所有这些都显示出更高的失眠率。 失眠（CBT-I）的认知行为疗法是一种多组分干预措施，具有睡眠 限制，刺激控制，睡眠卫生教育，认知疗法，可以包括放松技术。 CBT-I被认为是慢性失眠的一线治疗方法，但是在退伍军人中有效 使用的限制仍然存在。近年来，治疗方法的进展试图简化 CBT-I通过关注特定治疗组件的交付，减少治疗次数和/或 使用可轻松传播和实施的技术。简短的认知行为 失眠治疗（BCBT-I）代表一种经验测试的简短干预措施，可能会降低 通过减少实现治疗目标和使用混合治疗所需的减少会议，伯恩患者伯恩 管理（即面对面和远程医疗）。 为了更好地告知临床实践和未来研究，这项调查提案以评估比较 BCBT-I到VA标准CBT-的有效性，具有多个总体目标：1）在随机临床试验中 （RCT），评估BCBT-I与VA标准CBT-I的等效性（非效率）； 2）评估这些影响 功能康复结果的治疗方法； 3）评估这些治疗的影响 关于精神症状的方法； 4）以探索方式确定哪些患者因素 通过给定治疗作为发展可能的失眠表型的手段，可以最好地预测成功或失败 可以诊断以匹配患者特征和治疗类型，以帮助优化临床结果 （即一种“个性化医学”治疗方法）。 投资时间表由四个部分组成：1）睡眠，功能和精神病的基线评估 结果措施； 2）随机化和分配给CBT-I或BCBT-I； 3）治疗后评估； 4）3个月的随访评估。在40个月的招聘中，这项研究将注册和随机分组180 从VA初级保健和心理健康诊所的1：1比率的退伍军人（CBT-I：BCBT-I = 90:90） 卓越站点（VA圣地亚哥医疗保健系统和手指湖VAMC医疗保健系统）。为了 主要的研究目的，将通过添加的非劣效率进行的单方面平均差异测试进行 零值。次级分析将利用结构方程建模来评估CBT-I和BCBT-I如何 影响功能和社会心理结局。探索性目的将利用适度分析来更好 了解CBT-I和/或BCBT-I可能更有效。