Telemedicine Management of Veterans with Chronic Insomnia and PTSD

描述(由申请人提供)： 项目背景：大多数患有创伤后应激障碍的退伍军人都有慢性失眠的经历，这对生活质量有独立的负面影响，并可能加剧创伤后应激障碍的其他症状。认知行为治疗失眠(CBT-I)对原发性失眠患者非常有效，但缺乏受过CBT-I培训的临床医生限制了退伍军人获得这种治疗的机会。视频电话会议有望增加生活在农村和偏远地区的退伍军人获得护理的机会。以前没有研究评估通过视频电话会议向患有创伤后应激障碍和慢性失眠的退伍军人群体提供CBT-I。项目目标：我们将对患有创伤后应激障碍和慢性失眠的退伍军人进行随机对照试验，比较通过视频会议和面对面交付的CBT-I。目的1将确定通过视频会议实施CBT-I在改善失眠症状方面是否在临床上不逊于面对面治疗。目标2将比较两种治疗方法在成本和质量调整后的寿命年方面的差异。目的3将确定CBT-I在功能结果、睡眠质量和非睡眠相关PTSD症状方面的有效性。AIM 4将通过视频电话会议对CBT-I交付进行以患者和提供者为中心的形成性评估，以评估其广泛实施的潜在障碍。项目方法：患有创伤后应激障碍和慢性失眠的退伍军人在费城VAMC附属的社区门诊诊所(CBOC)接受初级护理，他们将被随机分配到CBOC接受以下干预之一：1)通过视频电话会议提供基于手动的CBT-I计划，2)面对面提供CBT-I计划，以及3)面对面提供睡眠卫生教育，这是一种已知的积极控制干预措施。参与者将在干预后的基线、2周和每3个月进行评估。目标1的主要结果衡量标准将是干预后6个月失眠严重指数(ISI)评分的变化。非劣势分析将被用来比较两种交付方法的有效性，并有一个预先指定的边际。结果将通过意向治疗和按协议程序确定。我们假设，通过视频会议进行CBT-I后ISI评分的变化在临床上不会逊于随后的面对面分娩。在目标2中，将收集退伍军人和非退伍军人的总医疗成本，以测试通过视频电话会议接受CBT-I的退伍军人的平均成本是否低于面对面护理。偏好将通过EuroQol和健康实用程序指数2进行评估。将比较通过视频电话会议和面对面接触节省的CBT-I成本和质量调整寿命年的比率的差异，以检验视频电话会议将具有更低成本和同等结果的假设。目的3将评估CBT-I对功能结果(简写形式12，工作和社会适应量表)、睡眠质量(匹兹堡睡眠质量指数、睡眠日记和手腕活动)以及创伤后应激障碍严重程度(创伤后应激障碍检查表中的非睡眠部分-军事)的影响。我们假设，这些功能结果和睡眠质量测量将在每种CBT-I交付方法后得到改善，CBT-I将改善与睡眠无关的创伤后应激障碍的严重程度。在目标4中，对CBT-I远程医疗交付的形成性评价将使用定性(有针对性的焦点小组，参与者和治疗师面谈)和定量措施(工作联盟清单、治疗可信度量表、自然减员)，这将有助于指导今后通过视频电话会议实施CBT-I。对退伍军人医疗保健的预期影响：上述假设和从形成性评估中获得的信息的确认将提供必要的证据，证明为患有创伤后应激障碍的退伍军人提供CBT-I远程医疗模式的临床实施是合理的。这将大大增加获得治疗的机会，特别是对居住在偏远和农村环境中的退伍军人，并降低与治疗有关的费用。

DESCRIPTION (provided by applicant): Project Background: Most Veterans with PTSD experience chronic insomnia that has independent, negative effects on quality of life and may exacerbate other symptoms of PTSD. Cognitive behavioral therapy for insomnia (CBT-I) is highly efficacious and effective in patients with primary insomnia but the lack of clinicians trained in CBT-I limits Veterans' access to this treatment. Video teleconferencing holds the promise of increasing access to care of Veterans living in rural and remote areas. No previous studies have evaluated the delivery of CBT-I to groups of Veterans with PTSD and chronic insomnia via video teleconferencing. Project Objectives: We will conduct a randomized, controlled trial of Veterans with PTSD and chronic insomnia to compare CBT-I administered by video teleconferencing versus in-person delivery. Aim 1 will determine if CBT-I administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Aim 2 will compare the differences in cost and quality-adjusted life years between the treatment delivery approaches. Aim 3 will determine the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. Aim 4 will conduct a patient- and provider- focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation. Project Methods: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC will be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants will be assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 will be the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. We hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non- VA total healthcare costs will be collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference will be assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 will assess the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). We hypothesize that these functional outcome and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 will use qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing. Anticipated Impacts on Veteran's Healthcare: Confirmation of the above hypotheses and the information gained from the formative evaluation will provide the evidence needed to justify clinical implementation of this telemedicine model for CBT-I delivery to Veterans with PTSD. This would significantly increase access to treatment, particularly for Veterans residing in remote and rural settings, and decrease treatment-related costs.