Cognitive behavioral therapy for insomnia in chronic traumatic brain injury

认知行为疗法治疗慢性创伤性脑损伤失眠

• 批准号: 10641741
• 负责人: Ansgar J. Furst
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10641741
• 关键词: Address; Aftercare; Arousal; Beds; Behavior Therapy; Characteristics; Chronic; Chronic Insomnia; Clinical Trials Design; Cognitive; Cognitive Therapy; Cognitive deficits; Collaborations; Combined Modality Therapy; Data; Education; Fatigue; Future; Health; Health Surveys; Healthcare Systems; Hospitals; Impairment; Individual; Injury; Inpatients; Intervention; Joints; Knowledge; Manuals; Measures; Mediator; Mental Health; Mental disorders; Meta-Analysis; Modeling; Multiple Trauma; Outcome; Outcome Measure; Pain; Patients; Pharmaceutical Preparations; Phase; Placebos; Post-Traumatic Stress Disorders; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Recording of previous events; Rehabilitation therapy; Research; Research Design; Research Project Grants; Risk; SF-36; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; TBI Patients; TBI treatment; Testing; Time; Training; Traumatic Brain Injury; Treatment outcome; Veterans; War; active control; affective disturbance; alternative treatment; clinical center; cognitive benefits; comorbidity; design; efficacy evaluation; evidence base; follow-up; improved; improved outcome; indexing; insight; mild traumatic brain injury; outcome prediction; pharmacologic; primary outcome; randomized, clinical trials; response; screening; secondary outcome; side effect; sleep health; sleeping pill; trial comparing

This application is a joint submission of the War Related Illness and Injury Study Center (WRIISC), The Polytrauma Network Site (PNS) and the VISN 21 Mental Illness Research, Educational and Clinical Center (MIRECC) at the VA Palo Alto Health Care System. One of the major post-deployment health concerns that the WRIISC & PNS are focusing on is Traumatic Brain Injury (TBI). The VISN 21 MIRECC has a long research history addressing sleep disorders in Veterans including several research projects on insomnia in Veterans. In recent years over 650 VA mental health clinicians have been trained in CBT-I by the VISN 21 MIRECC. The proposed collaboration between WRIISC, PNS and MIRECC will evaluate the efficacy of Cognitive Behavior Therapy for Insomnia (CBT-I) in TBI Veterans with chronic insomnia in a randomized controlled trial. CBT-I has been suggested to be a good alternative to pharmacological approaches in the treatment of TBI patients with insomnia but evidence to support this claim is lacking. This trial will compare CBT-I with a previously used manualized active control condition called “Credible Control Therapy for Insomnia” (CCT-I) in mild TBI (mTBI) patients suffering from insomnia. Like many previous control conditions in randomized controlled trials CCT-I includes a sleep hygiene component. Our hypotheses will be tested in a randomized controlled clinical trial. The randomization will be stratified by potential comorbidity of current Post-Traumatic Stress Disorder (PTSD) and use of sleep medications. After screening and randomization in the 2-week baseline phase, subjects will receive either CBT-I or CCT-I in the 6-week treatment phase. This 4-year proposal will include 120 mTBI patients (2 groups of n=60 each) with relevant measures collected at baseline, week 8 after treatment and week 32 for follow-up. The primary outcome will be the Insomnia Severity Index. The secondary outcome will be the SF 36-Item Health Survey.

本申请是战争相关疾病和伤害研究中心（WRIISC）， 多发性创伤网络网站（PNS）和VISN 21精神疾病研究，教育和临床中心 （MIRECC）在VA帕洛阿尔托医疗保健系统。部署后的主要健康问题之一是， WRIISC和PNS专注于创伤性脑损伤（TBI）。VISN 21 MIRECC进行了长期的研究 解决退伍军人睡眠障碍的历史，包括退伍军人失眠的几个研究项目。在 近年来，650多名退伍军人事务部心理健康临床医生接受了VISN 21 MIRECC的CBT-I培训。的 WRIISC，PNS和MIRECC之间的拟议合作将评估认知行为的有效性 在一项随机对照试验中，对患有慢性失眠症的TBI退伍军人进行失眠治疗（CBT-I）。CBT-I 已被认为是治疗TBI患者的药物方法的良好替代方案 但缺乏证据支持这一说法。 该试验将比较CBT-I与之前使用的称为“可信”的手动主动控制条件 在患有失眠症的轻度TBI（mTBI）患者中的“失眠症对照疗法”（CCT-I）。像许多 随机对照试验中的先前对照条件CCT-1包括睡眠卫生成分。 我们的假设将在一项随机对照临床试验中进行检验。随机化将按以下因素分层： 目前创伤后应激障碍（PTSD）和使用睡眠药物的潜在共病。后 在2周基线期的筛选和随机化中，受试者将在 6-周治疗阶段。这项为期4年的提案将包括120名mTBI患者（2组，每组n=60）， 在基线、治疗后第8周和第32周随访时收集相关测量值。主 结果将是损伤严重度指数。次要结局是SF 36项健康调查。