Multi-site, longitudinal trial evaluating the efficacy, mechanisms, and moderators of service dogs for military Veterans with PTSD

项目概要/摘要 退伍军人的创伤后应激障碍（PTSD）是一个重要的公共卫生问题。退伍军人自杀 发病率超过了一般人群，这种疾病造成了心理健康挑战，代价高昂 并使人衰弱。大多数患有创伤后应激障碍 (PTSD) 的退伍军人还患有共病心理健康诊断，例如 广泛性焦虑症、药物滥用障碍和重度抑郁症。退伍军人创伤后应激障碍（PTSD）的治疗 合并症是一个重要的治疗和康复问题。病症很复杂 并且难以治疗，高治疗退出率和无反应率促使一些退伍军人寻求治疗 补充性综合健康策略。一项有前途的补充战略是提供经过培训的人员 服务犬。多个研究小组的初步证据强调服务犬是一种有前途的补充 可以提供短期改进的基于证据的实践。然而，从长远来看， 作用机制和功效调节因素仍然很大程度上未知。因此，总体目标是 该提案旨在了解创伤后应激障碍 (PTSD) 服务犬如何、为何以及对谁最有效。 为了实现这一目标，本项目将评估纵向疗效和剂量反应曲线 为退伍军人 PTSD 症状和心理社会功能提供服务的犬（目标 1）。了解如何以及 为什么干预有效，该项目还将对潜在机制进行理论驱动的量化 可能调节服务犬功效的行动（目标 2）。最后，要了解为谁、在什么情况下 在干预效果最佳的情况下，该项目将通过以下方式定义服务犬功效的调节因素 检查治疗效果的异质性（目标 3）。该研究设计将包括一个双臂、 随机临床试验 (RCT)，在 0、6 和 12 个月进行纵向评估。评估将包括 六个数据流的综合监测，包括：(1) 临床医生对 PTSD 的盲法评估 症状学，(2) 心理社会功能标准化调查，(3) 生态瞬时评估 日常情绪体验和活动，（4）两大应激反应系统的唾液生物标志物 皮质醇和 α-淀粉酶，(5) 通过基于体动记录仪的腕带监测进行身体活动和睡眠，以及 (6) 犬类对行为、气质以及与人类伴侣的生理共同调节的评估。结果 预计将阐明服务犬对患有 PTSD 的退伍军人的临床影响，以及 生物行为作用机制和特点表明疗效中等。这些成果将支持 通过优化和整合加速补充和综合卫生干预措施的长期目标 基于证据的服务犬干预措施。因此，该项目将进一步推进科学认识 人与动物之间的互动对社会心理健康的影响。

PROJECT SUMMARY/ABSTRACT Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective. To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning (Aim 1). To understand how and why the intervention works, this project will also implement theory-driven quantification of potential mechanisms of action that may mediate service dog efficacy (Aim 2). Finally, to understand for whom and under what circumstances the intervention works best, this project will define moderators of service dog efficacy by examining the heterogeneity of treatment effects (Aim 3). The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments at 0, 6, and 12 months. Assessments will consist of comprehensive monitoring across six data streams, including: (1) blinded clinician assessment of PTSD symptomology, (2) standardized surveys of psychosocial functioning, (3) ecological momentary assessment of daily emotional experiences and activities, (4) salivary biomarkers of two major stress response systems via cortisol and alpha-amylase, (5) physical activity and sleep via actigraphy-based wristband monitoring, and (6) canine assessments of behavior, temperament, and physiological co-regulation with the human partner. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.