Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

描述(由申请人提供)： 治疗创伤后失眠和噩梦：对症状和生活质量的影响这项应用解决了广泛的挑战领域(04)临床研究和特定挑战主题，04-NR-103*改善患者和家人的生活质量随着积极作战行动的增加，暴露在创伤中的军事人员的数量正在迅速增加。对一些人来说，创伤的一个令人衰弱和影响深远的后果是患上创伤后应激障碍(PTSD)，大约20%的退伍军人受到与战争有关的创伤后会患上这种疾病。最近的估计表明，在持久自由行动/伊拉克自由行动(OEF/OIF)中，退伍军人在退伍军人管理局接受护理的比例甚至更高。创伤后应激障碍对个人、家庭和社会的短期和长期负面影响包括与健康相关的生活质量下降、严重的精神痛苦和并存的精神状况、身体健康不良、家庭功能下降和生产力丧失。这些问题的医疗后果表现为更高的自我报告健康状况不佳的比率，初级保健就诊次数增加，错过工作日的人数增加。随着越来越多的退伍军人从OEF/OIF返回，这些个人和社会后果预计将在未来几年增长。虽然存在对创伤后应激障碍的白天症状的有效治疗，但它们通常不治疗特定的夜间噩梦和失眠症状。创伤事件后报告的噩梦和失眠预示着创伤后应激障碍的发展，而这些障碍与健康风险和精神疾病的增加独立相关。值得注意的是，慢性噩梦与药物滥用和自杀风险的增加有关。对睡眠不良和睡眠障碍在患者群体中的负面影响的认识已经发展到了这样的程度，NIH在2009年4月召开了一次特别会议，题为“嗜睡和与健康相关的生活质量”，以强调这些问题。关于创伤后应激障碍，研究表明，噩梦和失眠通常不会在没有特别有针对性的干预下得到解决，这表明负面后果可能会在更长的时间内积累起来。这两种睡眠障碍都有循证治疗方法(失眠认知行为疗法CBT-I和意象排练疗法IRT)，但尚未在与军事相关的创伤患者身上进行彻底测试，也没有公开发表的研究报告在最近部署的现役人员中测试这些干预措施。此外，与只关注白天PTSD症状的治疗相比，目前尚不清楚治疗睡眠抱怨是否会对与健康相关的生活质量和日间症状产生更大的积极影响。因此，这项研究的总体目标是检验在那些有睡眠主诉的患者中增加循证睡眠治疗的个性化PTSD治疗是否可以更好地治疗所有的PTSD症状(即白天和夜间)，并改善与健康相关的生活质量和整体临床结果。这是一项受试者间的随机对照试验。同时符合失眠和反复噩梦诊断标准的创伤后应激障碍患者将被随机分配到两组中的一组[仅延长暴露(PE)治疗，或CBT-I/IRT+PE]，两组治疗时间相等。评估将在治疗前、治疗5周、12周和18周以及治疗后12周进行。评估包括睡眠障碍、与健康相关的生活质量、日间创伤后应激障碍症状和其他共病精神症状的客观和主观测量。患者将从退伍军人圣地亚哥医疗系统(退伍军人从部署归来后几个月内在那里看到)和海军医疗中心圣地亚哥(在那里现役人员在部署后更快看到)招募。据我们所知：1)这是第一次研究CBT-I和IRT作为其他经验证的创伤后应激障碍治疗的辅助手段的有效性；2)它的样本量将比目前发表的任何与战斗有关的创伤后应激障碍试验都要大；3)这将是第一项在最近部署的现役人员中系统检查这些治疗方法的研究；4)这将是迄今为止关于将与健康相关的生活质量作为特定目标结果的最大规模的睡眠干预研究。如果我们的假设得到证实，这项研究有可能为制定与战斗相关的创伤后应激障碍的有针对性的治疗计划提供有价值的信息，并有助于改善患者的整体福祉和生活质量，进而可能改善他们的家人。暴露在创伤中，特别是当它表现为创伤后应激障碍时，会给患者、家庭和社会带来许多负面后果。创伤后应激障碍最常见、最令人不安、最难治的症状是噩梦和失眠。这项研究将检验专门针对这些睡眠障碍的治疗是否可以改善临床结果，并提高最近受到战争相关创伤的个人的健康相关生活质量。

DESCRIPTION (provided by applicant): Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life This application addresses broad Challenge Area (04) Clinical Research and specific Challenge Topic, 04-NR- 103* Improving Quality of Life of Patients and Family Following a War-Related Traumatic Injury With an increase in active combat operations in recent years, the number of military personnel exposed to trauma is growing rapidly. One debilitating and far-reaching consequence of trauma for some individuals is the development of Post-Traumatic Stress Disorder (PTSD), with approximately 20% of veterans exposed to war- related trauma developing the disorder. Recent estimates suggest the prevalence within Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans presenting for care at the VA is even higher. The short- and long-term negative consequences of PTSD for the individual, family, and society include reduced health- related quality of life, significant mental distress and comorbid psychiatric conditions, poor physical health, decreased family functioning, and loss of productivity. The healthcare consequences of these problems manifest in greater rates of self-reported poor health, increased numbers of primary care visits, and increased numbers of missed workdays. With increasing numbers of veterans returning from OEF/OIF, these personal and societal consequences are expected to grow in coming years. While effective treatments for the daytime symptoms of PTSD exist, they typically leave untreated the specific nighttime complaints of nightmares and insomnia. Nightmares and insomnia reported in the wake of traumatic events predict development of PTSD, and these disorders are independently associated with increased risk of health and psychiatric morbidities. Notably, chronic nightmares are associated with increased risk of substance abuse and suicide. Recognition of the negative impact of poor sleep and sleep disorders across patient populations has grown to the point where NIH convened a special conference in April 2009 entitled, "Sleepiness and Health Related Quality of Life" to highlight these issues. With respect to PTSD, studies have shown nightmares and insomnia often do not resolve without specifically targeted interventions, suggesting the negative consequences can build over more years. There are evidence-based treatments for both sleep disorders (Cognitive Behavioral Therapy for Insomnia, CBT-I; and Imagery Rehearsal Therapy, IRT), but they have not been thoroughly tested in individuals with military-related trauma, and no published studies report testing these interventions in recently deployed active duty personnel. Furthermore, it is unclear if treating sleep complaints will positively impact health-related quality of life and daytime symptoms more so than treatment focused only on daytime symptoms of PTSD. The overall objective of this study, then, is to examine if personalizing PTSD treatment by adding evidence-based sleep treatments in those patients with sleep complaints can better treat the full spectrum of PTSD symptoms (i.e., both daytime and nighttime) and improve health-related quality of life and overall clinical outcomes. This is a between-subjects randomized control trial. Participants with PTSD who also meet diagnostic criteria for both insomnia and recurring nightmares will be randomly assigned to one of two groups [Prolonged Exposure (PE) treatment only, or CBT-I/IRT + PE] equated for length of treatment. Assessments will be conducted at pretreatment, treatment weeks 5, 12, and 18, and post-treatment week 12. Assessments include objective and subjective measures of sleep disturbances, health-related quality of life, daytime PTSD symptoms, and other comorbid psychiatric symptoms. Patients will be recruited from the VA San Diego Healthcare System (where veterans are seen within a few month of returning from deployment) and the Naval Medical Center San Diego (where active duty personnel are seen even sooner post-deployment). To our knowledge: 1) this is the first study to examine the utility of CBT-I and IRT as an adjunct to other empirically validated PTSD treatments; 2) it will have a greater sample size than any currently published trial in combat- related PTSD; 3) it will be the first study to systematically examine these treatments in recently deployed active duty personnel; and 4) it will be the largest study of the sleep interventions to date to have health-related quality of life as a specifically targeted outcome. If our hypotheses are borne out, this study has the potential to provide valuable information in developing targeted treatment plans for combat-related PTSD, as well as to contribute to improvements in the overall well-being and quality of life in patients and, by extension, likely their families as well. Exposure to trauma, especially when it manifests as Post-Traumatic Stress Disorder, results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health- related quality of life in individuals recently exposed to war-related trauma.