Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans with Gulf War Illness

 描述（由申请人提供）： 海湾战争病（GWI）是一种由波斯湾战争（GW）服务引起的多症状疾病，是影响GW退伍军人的最突出的健康问题之一。在GWI的退伍军人中，Increase很常见。例如，我们当前VA Merit GW项目中符合疾病控制和预防中心（CDC）GWI病例定义的所有退伍军人和符合堪萨斯GWI病例定义（与CDC 4病例定义不同，具有排除条件）的64%退伍军人的失眠严重程度指数评分表明临床失眠。此外，失眠严重程度和主观睡眠质量与GWI症状严重程度显著相关，如通过堪萨斯海湾战争军事历史和健康问卷在这些退伍军人中评估的（r>0.45，p <0.01）。这表明：（1）睡眠中断对系统产生不利影响（例如，认知、神经内分泌和自主神经），可能在GWI中起重要作用，以及（2）睡眠质量、睡眠-觉醒调节和疲劳（GWI和失眠个体的常见症状）之间存在相互联系。研究合作者Neylan和Maguen博士先前已经表明，认知行为疗法（CBT-I）可有效减少失眠和非睡眠创伤后应激障碍（PTSD）症状。因为在我们目前的VA Merit项目中，目前的PTSD症状严重程度也与退伍军人的失眠和GWI症状严重程度密切相关（r>0.45，p <0.01），我们假设CBT-I将类似地减少GW退伍军人的失眠和非睡眠GWI症状。拟议的研究将在CBT-I睡眠和非睡眠GWI症状的试点试验中测试这一假设。一般情况下，这种疾病认识不足，也得不到治疗。例如，在我们目前的VA Merit GW项目中，可能患有临床失眠症的退伍军人都没有听说过或被他们的VA医疗保健提供者转介到CBT-I。这表明，尽管退伍军人事务部在全国范围内推出了CBT-I，但患有GWI的退伍军人并不是CBT-I的目标人群。虽然CBT-I已经在许多与失眠共病的疾病中进行了研究，但我们认为在GWI的背景下检查CBT-I是重要的，因为：1）失眠在GWI退伍军人中很常见，2）未经治疗的失眠可能导致显著的医疗和精神疾病; 3）海湾战争结束近25年后，GWI仍然没有循证治疗。此外，我们建议修改CBT-I的电话交付，研究发现与面对面CBT-I一样有效，这是重要的，因为它将这种有效形式的行为睡眠疗法扩展到患有GWI的退伍军人，他们有身体和/或功能障碍，可能限制他们参与需要定期诊所就诊的治疗的能力。拟定的研究将采用一项双臂随机对照试验，在64名患有GWI（根据CDC和堪萨斯病例定义）和失眠症（根据DSM-5研究诊断标准）的退伍军人中研究电话递送CBT-I对睡眠和非睡眠GWI症状的疗效。一半的退伍军人将被随机分配到CBT-I组，另一半将被随机分配到常规治疗对照组。随机分配到对照组的退伍军人在完成研究后可以选择接受电话传递的CBT-I。主要结局将是基于随机分配至CBT-I组的治疗前至治疗后变化和6个月时治疗效果维持的组内比较的效应量。根据RAC 2014年的建议，“联邦海湾战争疾病研究的首要任务必须是确定有效的治疗方法，以改善海湾战争退伍军人的健康”，拟议的试验可能是确定非药物治疗的重要的第一步。000名退伍军人在服兵役期间受伤。

 DESCRIPTION (provided by applicant): Gulf War illness (GWI), a multisymptom condition resulting from service in the Persian Gulf War (GW), is one of the most prominent health issues affecting GW Veterans. Insomnia is common in Veterans with GWI. For example, all of the Veterans in our current VA Merit GW project who meet the Centers for Disease Control and Prevention (CDC) case definition for GWI and 64% of the Veterans who meet the Kansas GWI case definition (which, unlike the CDC4 case definition, has exclusionary conditions), have Insomnia Severity Index scores indicative of clinical insomnia. Furthermore, insomnia severity and subjective sleep quality are significantly correlated with GWI symptom severity, as assessed by the Kansas Gulf War Military History and Health Questionnaire (r's >0.45, p's <0.01) in these Veterans. This suggests that: (1) sleep disruption adversely affects systems (e.g., cognition, neuroendocrine, and autonomic) that likely play an important role in GWI, and (2) there are reciprocal links between sleep quality, sleep-wake regulation, and fatigue, a common symptom of individuals with GWI and insomnia. Study co-investigators Drs. Neylan and Maguen have previously shown Cognitive Behavioral Therapy for Insomnia (CBT-I) to be efficacious for reducing insomnia and non-sleep posttraumatic stress disorder (PTSD) symptoms. Because current PTSD symptom severity is also strongly correlated with insomnia and GWI symptom severity in Veterans in our current VA Merit project (r's >0.45, p's <0.01), we hypothesize that CBT-I will similarly reduce insomnia and non-sleep GWI symptoms in GW Veterans. The proposed study will test this hypothesis in a pilot trial of CBT-I for sleep and non-sleep GWI symptoms. Insomnia is commonly under-recognized and untreated. For example, none of the Veterans in our current VA Merit GW project who likely have clinical insomnia have heard of or have been referred to CBT-I by their VA healthcare providers. This suggests that, despite the VA's national roll-out of CBT-I, Veterans with GWI are not the target population for CBT-I. Although CBT-I has been studied in a number of disorders comorbid with insomnia, we contend that examining CBT-I in the context of GWI is important because: 1) insomnia is common in Veterans with GWI, 2) untreated insomnia can lead to significant medical and psychiatric morbidity; 3) there is still no evidence-based treatment for GWI nearly 25 years after the end of the Gulf War. Furthermore, our proposal to modify CBT-I for telephone delivery, which studies have found to be as efficacious as face-to-face CBT-I, is significant because it will extend this effective form of behavioral sleep therapy to the Veterans with GWI who have physical and/or functional impairments that may limit their ability to participate in treatments that require regular clinic visits. The proposed study will employ a two-arm randomized controlled trial to investigate the efficacy of telephone- delivered CBT-I for sleep and non-sleep GWI symptoms in 64 Veterans with GWI according to the CDC and Kansas case definitions and insomnia disorder according to DSM-5 research diagnostic criteria. Half of the Veterans will be randomized to CBT-I and half to a treatment-as-usual control group. Veterans randomized to the control group will have the option of receiving telephone-delivered CBT-I upon completion of the study. The primary outcomes will be effect sizes based on within-group comparisons of pre-to-post-treatment change and maintenance of treatment effects at 6 months in the group randomized to CBT-I. In light of the RAC's 2014 recommendation that the "first priority of federal Gulf War illness research must be the identification of effective treatments to improve the health of Gulf War Veterans," the proposed trial may be an important first step towards identifying a non-pharmacologic treatment with relatively low burden and few known risks that could benefit some of the estimated 175,000 Veterans with GWI injured during their military service.