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.

退伍军人在VA初级保健和心理健康诊所看到通常与睡眠投诉 失眠，尤其是失眠。例如，在一项横断面研究中， 2000-2010年间通过退伍军人健康管理局寻求护理的退伍军人，睡眠呼吸暂停（47%）， 失眠（26%）是最常见的诊断条件。在一项关于375持久行动的研究中 在自由/伊拉克自由行动退伍军人中，45%的人报告说他们花了很长时间试图入睡（> 30 21%的人报告总睡眠时间减少（< 4.5小时），56%的人报告在床上醒来的时间更长。 超过15%的夜晚。同样，在另一项对5,552名退伍军人的观察性研究中，57.2%的样本 人群中发现有失眠症。这个样本也是一系列临床疾病的高危人群， 包括创伤后应激障碍、创伤性脑损伤和疼痛;所有这些都显示出更高的失眠率。 认知行为疗法（CBT-I）是一种多成分干预， 限制、刺激控制、睡眠卫生教育、认知疗法，并且可以包括放松技术。 CBT-I被认为是慢性失眠的一线治疗方法，对退伍军人有效，然而， 使用限制仍然存在。近年来，治疗方法的进步试图简化 CBT-I，侧重于提供特定的治疗成分，减少治疗次数，和/或 使用便于传播和执行的技术。简要认知-行为 抑制疗法（bCBT-I）代表了一种经过经验检验的短暂干预， 通过减少达到治疗目标所需的疗程和使用混合治疗，减轻患者负担 给药（即，现场和远程医疗）。 为了更好地为临床实践和未来的研究提供信息，这项调查建议评估比较 bCBT-I对VA标准CBT-的有效性，有几个首要目标：1）在随机临床试验中 (RCT)，评价bCBT-I与VA标准CBT-I的等效性（非劣效性）; 2）评价这些 治疗方法对功能康复结果的影响; 3）评估这些治疗的影响 精神病学的方法; 4）以探索性的方式，确定哪些患者因素 最好的预测成功或失败与给定的治疗作为一种手段，发展失眠表型， 用于诊断，以匹配患者特征和治疗类型，帮助优化临床结局 (i.e.,“个性化医疗”的治疗方法）。 调查时间轴包括四个部分：1）睡眠、功能和精神的基线评估 结果测量; 2）随机化并分配至CBT-I或bCBT-I; 3）治疗后评估; （4）3个月随访评估。在40个月的招募期内，本研究将招募并随机分配180名 退伍军人在1：1的比例（CBT-I：bCBT-I= 90：90）从VA初级保健和心理健康诊所在两个中心， 卓越研究中心（VA San Diego Healthcare System和Finger Lakes VAMC Healthcare System）。为 主要研究目的，将进行单侧平均差异检验，并将非劣效性界值添加到 返回空值。二次分析将利用结构方程模型来评价CBT-I和bCBT-I 影响功能和心理社会结果。探索性目标将利用适度分析， 了解CBT-I和/或bCBT-I对谁更有效。