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: 9614797
• 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 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9614797
• 关键词: Address; Adverse effects; Aftercare; Arousal; Beds; Behavior Therapy; Characteristics; Chronic; Chronic Insomnia; Clinical; Clinical Trials Design; Cognitive; Cognitive Therapy; Cognitive deficits; Collaborations; Data; Fatigue; Future; Health; Health Surveys; Healthcare Systems; Hospitals; Hygiene; Impairment; Individual; Injury; Inpatients; Intervention; Joints; Knowledge; Lead; Measures; Mediator of activation protein; Mental Health; Mental disorders; Meta-Analysis; Modeling; Outcome; Outcome Measure; Pain; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Placebo Control; Post-Traumatic Stress Disorders; Quality of life; Randomized; Randomized Clinical Trials; 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; Testing; Time; Training; Traumatic Brain Injury; Treatment outcome; Veterans; War; active control; alternative treatment; cognitive benefits; comorbidity; design; disturbance in affect; evidence base; follow-up; improved; improved outcome; indexing; insight; mild traumatic brain injury; outcome prediction; primary outcome; response; screening; secondary outcome; 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.

本申请是由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)在弗吉尼亚州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关注的是创伤性脑损伤(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，包括几个关于退伍军人失眠的研究项目。在……里面 近年来，VISN 21 MIRECC对650多名退伍军人精神健康临床医生进行了CBT-I培训。这个 WRIISC、PNS和MIRECC之间拟议的合作将评估认知行为的有效性 脑损伤退伍军人慢性失眠治疗(CBT-I)随机对照试验CBT-I 已经被认为是治疗脑外伤患者的一种很好的药物替代方法 与失眠有关，但缺乏支持这一说法的证据。 这项试验将CBT-I与以前使用的手动主动控制条件进行比较 轻度颅脑损伤患者失眠的对照治疗“(CCT-I)。像许多人一样 在随机对照试验CCT-I中，以前的对照条件包括睡眠卫生成分。 我们的假设将在随机对照临床试验中得到验证。随机化将按以下方式分层 当前创伤后应激障碍(PTSD)和睡眠药物使用的潜在共病。之后 在为期两周的基线阶段，受试者将接受CBT-I或CCT-I 疗程6周。这项为期4年的计划将包括120名mTBI患者(两组各60人)， 分别于基线、治疗后8周和32周收集相关指标进行随访。初级阶段 结果将是失眠严重程度指数。次要结果将是SF 36项健康调查。