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）是一个严重的公共卫生问题。退伍军人自杀 发病率超过普通人群，这种疾病造成了代价高昂的心理健康挑战 和衰弱。大多数患有创伤后应激障碍的退伍军人也有共病的心理健康诊断，如 广泛性焦虑症、物质滥用症和严重抑郁症。退伍军人PTSD的治疗 和共病障碍代表了重要的治疗和康复问题。这种紊乱很复杂 而且很难治疗，高治疗辍学率和无反应率促使一些退伍军人寻求 补充性综合保健战略。一个有希望的补充战略是提供一个训练有素的 服务犬多个研究小组的初步证据显示，服务犬是一种有前途的补充 以证据为基础的做法，可以提供短期的改善。然而，长期的有效性， 作用机制和功效调节因素在很大程度上仍然未知。因此， 这项建议是为了了解如何，为什么，以及谁的创伤后应激障碍服务犬是最有效的。 为了实现这一目标，本项目将评估的纵向疗效和剂量反应曲线 退伍军人创伤后应激障碍诊断和心理社会功能的服务犬（目标1）。了解如何和 为什么干预工作，这个项目还将实施理论驱动的量化的潜在机制 可能介导服务犬功效的作用（目标2）。最后，要了解为谁服务，在什么情况下 在干预效果最好的情况下，本项目将通过以下方式定义服务犬功效的调节者： 检查治疗效果的异质性（目标3）。研究设计将包括双臂， 随机临床试验（RCT），在0、6和12个月时进行纵向评估。评估将包括 在六个数据流中进行全面监测，包括：（1）PTSD的盲法临床医生评估 心理学，（2）心理社会功能的标准化调查，（3） 日常情绪体验和活动，（4）两个主要应激反应系统的唾液生物标志物， 皮质醇和α-淀粉酶，（5）通过基于活动记录的腕带监测的身体活动和睡眠，以及（6） 犬的行为，气质和生理共同调节与人类合作伙伴的评估。结果 有望阐明服务犬对患有创伤后应激障碍的退伍军人的临床影响，以及 生物行为作用机制和调节功效的特征。这些成果将支持 长期目标是通过优化和 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， 人类与动物的互动对心理健康的影响。

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.