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

描述（由申请人提供）： 治疗创伤后的失眠和失眠：对症状和生活质量的影响该应用程序解决了广泛的挑战领域（04）临床研究和特定的挑战主题，04-NR-103 * 改善患者和家庭的生活质量在战争相关的创伤后随着近年来积极的战斗行动的增加，暴露于创伤的军事人员的数量正在迅速增长。对于一些个体而言，创伤的一个使人衰弱且影响深远的后果是创伤后应激障碍（PTSD）的发展，其中大约20%的暴露于战争相关创伤的退伍军人发展出该障碍。最近的估计表明，持久自由行动/伊拉克自由行动（OEF/OIF）退伍军人在VA接受护理的患病率甚至更高。PTSD对个人、家庭和社会的短期和长期负面后果包括与健康相关的生活质量降低、严重的精神痛苦和共病精神状况、身体健康状况差、家庭功能下降和生产力丧失。这些问题的医疗后果表现在自我报告的健康状况不佳的比率更高，初级保健访问次数增加，以及错过工作日的数量增加。随着越来越多的退伍军人从"持久自由行动"/"伊法组织"返回，这些个人和社会后果预计将在未来几年增加。虽然对PTSD的日间症状有有效的治疗方法，但它们通常不会治疗噩梦和失眠的特定夜间投诉。在创伤事件后报告的失眠和失眠预示着PTSD的发展，这些疾病与健康和精神病发病率的风险增加独立相关。值得注意的是，长期做噩梦与药物滥用和自杀的风险增加有关。对睡眠不良和睡眠障碍对患者群体的负面影响的认识已经发展到NIH在2009年4月召开了一次题为"嗜睡和健康相关的生活质量"的特别会议来强调这些问题。关于创伤后应激障碍，研究表明，如果没有专门针对性的干预措施，噩梦和失眠往往无法解决，这表明负面后果可能会持续多年。对于这两种睡眠障碍都有循证治疗方法（认知行为疗法，CBT-I;和意象排练疗法，IRT），但它们尚未在与军事有关的创伤患者中进行彻底测试，也没有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，目前还不清楚治疗睡眠投诉是否会比只关注PTSD的日间症状更能积极影响与健康相关的生活质量和日间症状。因此，本研究的总体目标是检查通过在有睡眠投诉的患者中添加基于证据的睡眠治疗来个性化PTSD治疗是否可以更好地治疗PTSD症状的全谱（即，白天和夜间），并改善健康相关的生活质量和总体临床结果。这是一项受试者间随机对照试验。符合失眠和复发性噩梦诊断标准的PTSD受试者将被随机分配到两组之一[仅延长暴露（PE）治疗，或CBT-I/IRT + PE]，治疗时间相等。将在治疗前、治疗第5、12和18周以及治疗后第12周进行评估。评估包括睡眠障碍、健康相关生活质量、日间PTSD症状和其他共病精神症状的客观和主观测量。患者将从VA圣地亚哥医疗保健系统（退伍军人在部署后几个月内就可以看到）和圣地亚哥海军医疗中心（现役人员在部署后更快就可以看到）招募。据我们所知：1）这是第一项研究CBT-I和IRT作为其他经经验验证的PTSD治疗的辅助手段的效用; 2）它将比目前发表的任何与战斗相关的PTSD试验的样本量更大; 3）这将是第一项系统地检查这些治疗方法在最近部署的现役人员中的应用的研究; 4）这将是迄今为止最大的睡眠干预研究，将健康相关的生活质量作为一个特定的目标结果。如果我们的假设得到证实，这项研究有可能为制定与战斗有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健康和生活质量，并可能延长他们的家庭。暴露于创伤，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。一些最常见的，令人不安的，和治疗抵抗性的PTSD症状是噩梦和失眠。这项研究将检查专门针对这些睡眠障碍的治疗是否可以改善临床结果，并提高最近暴露于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.