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

基本信息

批准号：
10554091
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
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-11-01 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10554091
关键词：
Academy Address Adopted 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 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 Regimen Rehabilitation Outcome 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 benefits cognitive rehabilitation comorbid depression 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 recruit rehabilitation research research and development secondary outcome service member side effect skills social sound symposium treatment effect treatment response trial comparing unhealthy lifestyle wound

项目摘要

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：在这项修订后的CDA-2提案中，ORFF博士提出了研究一种行为疗法方法，针对具有轻度脑损伤病史（MTBI）病史的退伍军人的失眠（CBT-I）的认知行为疗法和当前的失眠症。该项目有三个目标：1）确定MTBI后失眠的退伍军人中CBT-I对睡眠教育的效率； 2）评估睡眠效率作为CBT-I对合并症抑郁症症状以及PTSD症状以及全球功能和残疾症状不同影响的介体； 3）检查主持变量（例如抑郁症，PTSD，身体疼痛）对CBT-I治疗结果的影响。 Orff博士计划在基线评估后将70名OEF/OIF/OND退伍军人注册，他们将随机分配给CBT-I或睡眠教育的六周。这两个条件适当匹配，以获取时间和注意力。这些患者将在六周内进行遵循，并评估睡眠和其他结局的变化。申请人：亨利·奥尔夫（Henry Orff）博士拥有罗切斯特大学（University of Rochester）的1988年卫生与社会和心理学学士学位，SDSU/UCSD的2010年临床心理学博士学位以及博士后任命。自1996年担任睡眠实验室的研究助理以来，他就一直对睡眠研究感兴趣。他列出了23个出版物，其中7个是首次撰写的。他被授予F31 NRSA博士前研究金。他的职业生涯中的正确时刻是获得这一CDA-2奖。导师/S：心理团队非常适合Orff博士的目的。所有（除了Golshan博士）都接受了临床心理学家的培训，并且都写了强有力的认可书。 Elizabeth Twamley博士将是MTBI的随机临床试验和退伍军人康复的主要导师。她是神经心理学部门的负责人，压力和心理健康卓越中心，也是UCSD的精神病学副教授。她已经制定并测试了TBI退伍军人的两种干预措施。她的资金充足，发表，拥有良好的心理经验。她每周都会与Orff博士见面，并花5％的时间。菲利普·盖尔曼（Philip Gehrman）博士将是CBT-I和治疗保真度的精神。他是费城VAMC行为睡眠医学计划的主任，也是美国宾夕法尼亚州精神病学心理学助理教授。他专注于失眠症，并且是CBT-I的国家教练。他发表得很好，也有良好的心理经验。他将通过电话或Skype与Orff博士会面，并花费5％的时间。艾米·雅克（Amy Jak）博士将成为MTBI和神经心理学的心理。她是VA圣地亚哥TBI认知康复的主任，也是UCSD的精神病学助理教授。她是UCSD/VA心理学实习计划的联合主任。她发表得很好，有良好的心理经验。她将每月与候选人见面，并花5％的时间。 Sonia Ancoli-Israel，Phd。将成为行为睡眠医学和专业发展的心理。她是UCSD的精神病学和医学名誉教授，吉林睡眠和进时间医学研究中心主任。她获得了行为睡眠药物的认证。她的职业生涯很杰出，将每月与Orff博士会面。 Shahrokh Golshan博士将在3％的时间提供生物统计学精神。培训计划： ORFF博士提出了一项培训计划，该计划将包括临床睡眠培训，TBI培训，RCT培训和专业发展培训。他将通过在当地会议和国家会议上的心理，课程和出席的结合来实现这一目标。这些培训目标和描述的方法是适当的。意义：迄今为止，在该人群中尚无CBT-I研究。考虑到相对高的患病率年轻退伍军人的MTBI以及与MTBI和精神疾病（如抑郁症和PTSD）的睡眠障碍高度共同出现，这是一项重要的研究，有可能使许多退伍军人在VA护理中受益。此外，这是一种非药物的方法，从而提供了潜在有害和加性方案的替代方法。方法：该方法是一种声音，与先前的应用程序相比，它进行了周到的改进。有一些麻烦的问题。 1）ORFF博士计划随机对象，以使研究助理（将进行评估）失明。研究助理不会随机化是很好的。但是，理想情况下，第三方（评估者和干预主义者都不是随机分组，以确保没有主题的“樱桃挑选”。 2）目前尚不清楚谁将提供控制条件。这些人应尽可能与CBT-I干预主义者（例如，教育水平，经验）相匹配。 3）请描述如何进行失眠诊断（主要研究包含变量）。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：招募将入学的70名退伍军人招募应该没有问题。 Orff博士是该CDA-2奖的出色候选人。他仔细地改善了这一修订后的应用程序，并组建了一支出色的心理团队。鉴于他在睡眠研究方面的丰富经验，他正处于职业生涯的正确阶段。这项研究的目的很简单，研究设计恰恰相反。关注的四个问题相对较小，很容易解决。道德/安全问题：申请人愿意为CBT-I提供“在完成该计划后不延迟延迟”来控制患者。尽管这是令人钦佩的，并且可能有助于招募，但是直到所有受试者分析结果后，这样做才是不道德的。假设CBT-I优于睡眠教育是很明显的（毕竟这就是为什么正在进行研究的原因）。临床相关性：失眠和MTBI在年轻退伍军人中很常见。改善睡眠可能会对经常与MTBI（例如PTSD和抑郁症）以及功能性和残疾同时发生的条件产生有益的影响。此外，作为一种非药物方法，它可能比没有成瘾风险和更少副作用的药物更安全。预算：无问题其他问题：无