Cognitive Behavioral Therapy for Insomnia for Veterans with History of TBI

针对有 TBI 病史的退伍军人失眠的认知行为疗法

• 批准号: 9198172
• 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: 2015
• 资助国家: 美国
• 起止时间: 2015-11-01 至 2020-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9198172
• 关键词: Academy; Address; Adopted; Adverse effects; Afghanistan; Alcohols; American; Appointment; Attention; Award; Behavioral; Biometry; Brain Concussion; Brain Injuries; Budgets; Caring; Chronic; Chronic Insomnia; Clinical; Clinical Psychology; Cognitive; Cognitive Therapy; Complex; Development; Diagnosis; Distal; Doctor of Philosophy; Drug abuse; Education; Educational Background; Effect Modifiers (Epidemiology); Enrollment; Ensure; Environment; Ethics; Evaluation; Evidence based practice; Evidence based treatment; Feeling suicidal; Fellowship; Freedom; Funding; Goals; Health; Healthcare Systems; High Prevalence; Individual; Injury; Internships; Intervention; Investigation; Iraq; Israel; Lead; Letters; Literature; Manuscripts; Measures; Mediator of activation protein; Medicine; Mental Depression; Mental Health; Mental disorders; Mentors; Mentorship; Minor; National Research Service Awards; Neuropsychology; Occupational; Outcome; Outcome Assessment; Outcome Measure; Pain; Patients; Pharmaceutical Preparations; Philadelphia; Phonation; Polysomnography; Population; Post-Concussion Syndrome; Post-Traumatic Stress Disorders; Postdoctoral Fellow; Psychiatry; Psychologist; Psychology; Publications; Publishing; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Recovery; Recruitment Activity; Regimen; Rehabilitation Outcome; Rehabilitation Research; Rehabilitation therapy; Reporting; Research; Research Assistant; Research Design; Research Personnel; Risk; Safety; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Societies; Staging; Statistical Data Interpretation; Stress; Supervision; Symptoms; Telephone; Testing; Therapeutic; Time; Training; Training Programs; Traumatic Brain Injury; Treatment outcome; Universities; Veterans; War; Writing; addiction; associated symptom; blind; career; clinically relevant; cognitive rehabilitation; comorbid depression; depressive symptoms; design; disability; experience; improved; interest; meetings; mid-career faculty; mild traumatic brain injury; negative affect; neuromuscular; operation; patient population; physical conditioning; potential biomarker; pre-doctoral; primary outcome; professor; programs; psychologic; research and development; secondary outcome; service member; skills; social; sound; symposium; treatment effect; treatment response; trial comparing; unhealthy lifestyle; wound

 DESCRIPTION: In this revised CDA-2 proposal, Dr. Orff proposes to study a behavioral therapeutic approach, Cognitive Behavioral Therapy for Insomnia (CBT-I) for veterans with a history of mild traumatic brain injury (mTBI) and current insomnia. There are three aims to this project: 1) determine the efficacy of CBT-I relative to Sleep Education in veterans with insomnia following mTBI; 2) evaluate sleep efficiency as a mediator of distal effects of CBT-I on symptoms of comorbid depression and PTSD and global functioning and disability; 3) examine the effects of moderator variables (e.g., depression, PTSD, physical pain) on CBT-I treatment outcomes. Dr. Orff plans to enroll 70 OEF/OIF/OND veterans who, following baseline assessments, will be randomly assigned to six weeks of either CBT-I or Sleep Education. The two conditions are matched appropriately for time and attention. These patients will be followed over the six weeks and assessed for changes in sleep and other outcomes. Applicant: Dr. Henry Orff has a 1988 BA in Health and Society and Psychology from University of Rochester, a 2010 PhD in Clinical Psychology from SDSU/UCSD, and post-doctoral appointments. He has been interested in sleep research since 1996 when he was a research assistant in a sleep lab. He lists 23 publications, seven of which are first authored. He was awarded a F31 NRSA pre-doctoral fellowship. He is at the right point in his career to pursue this CDA-2 award. Mentor/s: The mentoring team is excellent and well suited for Dr. Orff's purposes. All (except Dr. Golshan) are trained as clinical psychologists and all have written strong letters of endorsement. Elizabeth Twamley, PhD, will be the primary mentor for randomized clinical trials and rehabilitation of veterans with mTBI. She is Chief of the Neuropsychology Unit, Center of Excellence for Stress and Mental Health, and an Associate Professor of Psychiatry at UCSD. She has developed and tested two interventions for veterans with TBI. She is well funded and published and has good mentoring experience. She will meet weekly with Dr. Orff and devote 5% time. Philip Gehrman, PhD, will be the mentor for CBT-I and treatment fidelity. He is the Director of the Behavioral Sleep Medicine Program at the Philadelphia VAMC and Assistant Professor of Psychology in Psychiatry at U. Penn. He focuses on insomnia and is a national trainer for CBT-I. He is well published and also has good mentoring experience. He will meet with Dr. Orff by phone or skype and devote 5% time. Amy Jak, PhD, will serve as the mentor for mTBI and neuropsychology. She is the Director of TBI Cognitive Rehabilitation at the VA San Diego and an Assistant Professor of Psychiatry at UCSD. She is the co-director of the UCSD/VA psychology internship program. She is well published and has good mentoring experience. She will meet with the candidate monthly and devote 5% time. Sonia Ancoli-Israel, PhD., will serve as a mentor for behavioral sleep medicine and professional development. She is Professor Emeritus of Psychiatry and Medicine at UCSD and Director of the Gillin Sleep and Chronomedicine Research Center. She is certified in Behavioral Sleep Medicine. She has had a distinguished career and will meet with Dr. Orff monthly. Shahrokh Golshan, PhD, will provide biostatistics mentoring at 3% time. Training Program: Dr. Orff proposes a training program which will consist of clinical sleep training, TBI training, RCT training, and professional development training. He will accomplish this through a combination of mentoring, coursework, and attendance at local conferences and national meetings. These training goals and the approach described are appropriate. Significance: To date, there are no studies of CBT-I in this population. Given the relatively high prevalence of mTBI in younger veterans and the high co-occurrence of sleep disturbance with both mTBI and psychiatric disorders such as depression and PTSD, this is an important study that could potentially benefit many veterans in VA care. Furthermore, it is a non-pharmaceutical approach, thereby offering an alternative to potentially harmful and addictive regimens. Approach: The approach is a sound one, and considerably improved compared with the previous application. There are just a few issues that are troublesome. 1) Dr. Orff plans on randomizing subjects in order to keep the research assistant (who will be doing the evaluations) blind. It is good that the research assistant will not be randomizing; however, ideally a third party (neither assessor nor interventionist) should be doing the randomization to ensure that there is no "cherry picking" of the subjects. 2) It was unclear who would deliver the control condition. These individuals should be matched to the CBT-I interventionists as much as possible (e.g., education level, experience). 3) Please describe how the insomnia diagnosis (main study inclusion variable) will be made. Environment: The environment is excellent, especially the sleep lab which will be used for baseline and outcome assessments. Feasibility: There should be no problem recruiting the 70 veterans who will be enrolled in this study. Dr. Orff is an excellent candidate for this CDA-2 award. He has considerably improved this revised application and has assembled an outstanding mentoring team. Given his extensive experience with sleep research, he is at the right stage of his career to pursue this award. The aims of this study are straightforward, and the study design follows accordingly. The four issues of concern are relatively minor and easily fixed. Ethical/Safety Issues: The applicant is willing to provide CBT-I to control patients "without delay at the completion of their participation in the program." While this is admirable and may help recruitment, it is not ethical to do so until after the results have been analyzed from all subjects. It is presumptuous to assume that CBT-I will be superior to Sleep Education (after all, that's why the study is being conducted). Clinical Relevance: Insomnia and mTBI are common among younger veterans. Improving sleep could have salutary effects on conditions that frequently co-occur with mTBI, such as PTSD and depression, as well as functioning and disability. Additionally, as a non-pharmaceutical approach, it is likely safer than medications with no risk of addiction and fewer side effects. Budget: No concerns Other Issues: None

 描述： 在这份修订后的 CDA-2 提案中，奥尔夫博士提议为有轻度创伤性脑损伤 (mTBI) 病史和目前失眠的退伍军人研究一种行为治疗方法，即失眠认知行为疗法 (CBT-I)。 该项目有三个目标：1）确定 CBT-I 相对于睡眠教育对 mTBI 后失眠的退伍军人的功效； 2) 评估睡眠效率作为 CBT-I 对共病抑郁症和 PTSD 症状以及整体功能和残疾的远端影响的中介因素； 3) 检查调节变量（例如抑郁、PTSD、身体疼痛）对 CBT-I 治疗结果的影响。 奥尔夫博士计划招募 70 名 OEF/OIF/OND 退伍军人，在基线评估后，他们将被随机分配接受为期六周的 CBT-I 或睡眠教育。 这两个条件在时间和注意力上是适当匹配的。 这些患者将在六周内接受随访，并评估睡眠和其他结果的变化。 申请人： Henry Orff 博士于 1988 年获得罗彻斯特大学健康与社会和心理学学士学位，2010 年获得 SDSU/UCSD 临床心理学博士学位，并获得博士后职位。 自1996年担任睡眠实验室研究助理以来，他一直对睡眠研究感兴趣。 他列出了 23 篇出版物，其中 7 篇是第一作者。 他获得了 F31 NRSA 博士前奖学金。 他正处于职业生涯中追求 CDA-2 奖项的正确时机。 导师： 指导团队非常优秀，非常适合奥尔夫博士的目的。 所有人（除了戈尔山博士）都接受过临床心理学家的培训，并且都写了强有力的认可信。 Elizabeth Twamley 博士将担任 mTBI 退伍军人随机临床试验和康复的主要导师。 她是压力和心理健康卓越中心神经心理学部门的负责人，也是加州大学圣地亚哥分校的精神病学副教授。 她为患有 TBI 的退伍军人开发并测试了两种干预措施。 她拥有充足的资金和出版成果，并拥有良好的指导经验。 她每周都会与奥尔夫博士会面，并投入 5% 的时间。 Philip Gehrman 博士将担任 CBT-I 和治疗保真度方面的导师。 他是费城 VAMC 行为睡眠医学项目主任，也是宾夕法尼亚大学精神病学心理学助理教授。 他专注于失眠症，并且是 CBT-I 的国家培训师。 他发表过很多著作，并且拥有良好的指导经验。 他将通过电话或Skype与奥尔夫博士会面，并投入5%的时间。 Amy Jak 博士将担任 mTBI 和神经心理学的导师。 她是圣地亚哥退伍军人管理局 TBI 认知康复中心主任，也是加州大学圣地亚哥分校精神病学助理教授。 她是 UCSD/VA 心理学实习项目的联合主任。 她发表过很多著作，并且拥有良好的指导经验。 她每月都会与候选人会面，并投入 5% 的时间。 Sonia Ancoli-Israel 博士将担任行为睡眠医学和专业发展领域的导师。 她是加州大学圣地亚哥分校精神病学和医学名誉教授以及吉林睡眠和时间医学研究中心主任。 她获得了行为睡眠医学认证。 她有着杰出的职业生涯，每月都会与奥尔夫博士会面。 Shahrokh Golshan 博士将在 3% 的时间内提供生物统计学指导。 培训计划： 奥尔夫博士提出了一个培训计划，其中包括临床睡眠培训、TBI培训、RCT培训和专业发展培训。 他将通过指导、课程作业以及参加当地会议和全国会议来实现这一目标。 这些培训目标和所描述的方法是适当的。 意义： 迄今为止，尚无针对该人群的 CBT-I 研究。 鉴于患病率相对较高 年轻退伍军人中的 mTBI 以及睡眠障碍与 mTBI 和抑郁症和 PTSD 等精神疾病的高度共存，这是一项重要的研究，可能会使退伍军人管理局护理中的许多退伍军人受益。 此外，它是一种非药物方法，因此提供了潜在有害和成瘾疗法的替代方案。 方法： 该方法是一种合理的方法，并且与以前的应用程序相比有了很大的改进。 只是有几个问题比较麻烦。 1) 奥尔夫博士计划对受试者进行随机分配，以使研究助理（将进行评估）保持盲目。 研究助理不会随机化是件好事；然而，理想情况下，应该由第三方（既不是评估者也不是干预者）进行随机化，以确保不会对受试者进行“挑选”。 2）不清楚谁来提供控制条件。 这些人应尽可能与 CBT-I 干预者相匹配（例如，教育水平、经验）。 3) 请描述如何进行失眠诊断（主要研究纳入变量）。 环境：环境非常好，尤其是用于基线和结果评估的睡眠实验室。 可行性：招募 70 名退伍军人参加本研究应该没有问题。 奥尔夫博士是 CDA-2 奖的优秀候选人。 他大大改进了修改后的应用程序，并组建了一支出色的指导团队。 鉴于他在睡眠研究方面的丰富经验，他正处于职业生涯追求这一奖项的正确阶段。 本研究的目的很简单，研究设计也相应地遵循。 这四个问题相对较小且容易解决。 道德/安全问题： 申请人愿意提供 CBT-I 来控制患者“在完成项目参与后立即”。 虽然这是令人钦佩的并且可能有助于招募，但在对所有受试者的结果进行分析之前这样做是不道德的。 认为 CBT-I 优于睡眠教育的想法是冒昧的（毕竟，这就是进行这项研究的原因）。 临床相关性： 失眠和 mTBI 在年轻退伍军人中很常见。 改善睡眠可能对经常与 mTBI 同时发生的疾病（如 PTSD 和抑郁症）以及功能和残疾产生有益的影响。 此外，作为一种非药物方法，它可能比药物更安全，没有成瘾风险，副作用也更少。 预算：不用担心 其他问题：无