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: 9768249
• 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/9768249
• 关键词: Address; Aftercare; Arousal; Beds; Behavior Therapy; Characteristics; Chronic; Chronic Insomnia; Clinical Trials Design; Cognitive; Cognitive Therapy; Cognitive deficits; Collaborations; Data; Fatigue; Future; Health; Health Surveys; Healthcare Systems; Hospitals; 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; TBI treatment; Testing; Time; Training; Traumatic Brain Injury; Treatment outcome; Veterans; War; active control; affective disturbance; alternative treatment; clinical center; cognitive benefits; comorbidity; design; evidence base; follow-up; improved; improved outcome; indexing; insight; mild traumatic brain injury; outcome prediction; primary outcome; 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.

这份申请是由战争相关疾病和伤害研究中心（WRIISC）、美国陆军和陆军联合提交的