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

多地点、纵向试验评估服务犬对患有创伤后应激障碍 (PTSD) 退伍军人的功效、机制和调节因素

• 批准号: 10690188
• 负责人: Marguerite Elizabeth O'Haire
• 金额: $ 66.39万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-07 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10690188
• 关键词: Address; Affect; Animals; Arousal; Behavior assessment; Biological Markers; Blinded; Canis familiaris; Characteristics; Clinical; Clinical Practice Guideline; Clinical Trials; Complement; Complementary Health; Complex; Control Groups; Diagnosis; Disease; Dose; Dropout; Ecological momentary assessment; Effectiveness; Effectiveness of Interventions; Evidence based intervention; Evidence based practice; Evidence based treatment; Funding; General Population; Generalized Anxiety Disorder; Goals; Health; Heterogeneity; Human; Hydrocortisone; Individual; Integrative Medicine; International; Intervention; Knowledge; Lighting; Major Depressive Disorder; Mediating; Mental Health; Methodology; Monitor; Outcome; Palate; Pathway interactions; Physical activity; Physiological; Physiology; Pilot Projects; Post-Traumatic Stress Disorders; Process; Provider; Public Health; Randomized Clinical Trials; Regulation; Rehabilitation therapy; Research; Research Design; Research Personnel; Salivary; Scientific Advances and Accomplishments; Services; Site; Sleep; Social Facilitation; Social support; Standardization; Stress; Substance abuse problem; Suicide; Surveys; Symptoms; System; Temperament; Testing; Therapeutic; Training; Treatment Efficacy; United States National Institutes of Health; Validation; Veterans; Work; actigraphy; alpha-amylase; arm; base; biobehavior; biological adaptation to stress; biopsychosocial; clinically significant; comorbidity; completed suicide; cost; data streams; distraction; efficacy evaluation; efficacy trial; emotional experience; evidence base; improved; military veteran; multidisciplinary; multimodality; post-traumatic symptoms; psychosocial; psychosocial rehabilitation; rehabilitation strategy; response; suicide rate; theories; treatment effect; usual care arm; welfare

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.

项目摘要/摘要 军事退伍军人的创伤后应激障碍（PTSD）是一个关键的公共卫生问题。退伍军人自杀 利率超过了普通人群，这种疾病造成了心理健康挑战，这是昂贵的 和使人衰弱。大多数具有PTSD的退伍军人也有合并的心理健康诊断，例如 普遍的焦虑症，药物滥用障碍和严重抑郁症。老将PTSD的治疗 合并症是一个重要的治疗和康复问题。该疾病很复杂 而且很难治疗，高处辍学和无响应率刺激了一些退伍军人寻求 互补的综合健康策略。一种有希望的互补策略是提供经过训练的 服务犬。多个研究小组之间的初步证据突出显示服务犬是一种有希望的补充 可以提供短期改进的循证实践。但是，长期有效性， 作用机理和功效的主持人在很大程度上尚不清楚。因此， 该建议是了解如何，为什么，以及为谁最有效的PTSD服务犬。 为了解决这一目标，本项目将评估纵向功效和剂量反应曲线 服务犬用于老将PTSD症状和社会心理功能（AIM 1）。了解如何和 为什么干预起作用，该项目还将实施以理论为导向的潜在机制的量化 可能介导服务犬功效的动作（AIM 2）。最后，了解谁以及在什么 干预措施效果最好，该项目将通过 检查治疗效果的异质性（AIM 3）。研究设计将由两臂组成 随机临床试验（RCT）在0、6和12个月时进行纵向评估。评估将组成 跨六个数据流的全面监控，包括：（1）盲目的临床医生评估PTSD 症状学，（2）对心理功能的标准化调查，（3）生态瞬时评估 日常情感体验和活动，（4）通过 皮质醇和α-淀粉酶，（5）通过基于Attraphy的腕带监测和（6）的体育活动和睡眠 与人类伴侣的行为，气质和生理共同调节的犬类评估。结果 预计将阐明使用PTSD的军退伍军人对服务犬的临床影响，以及 中等疗效的作用和特征的生物行为机制。这些结果将支持 通过优化和 基于证据的服务犬干预措施。因此，该项目将进一步提高科学理解 人为社会健康的人类互动。