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: 10308302
• 负责人: Marguerite Elizabeth O'Haire
• 金额: $ 67.46万
• 依托单位: PURDUE UNIVERSITY
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308302
• 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; emotional functioning; 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 退伍军人中的创伤后应激障碍(PTSD)是一个严重的公共卫生问题。老兵自杀 发病率高于普通人群，这种疾病造成了代价高昂的心理健康挑战 而且让人虚弱。大多数患有创伤后应激障碍的退伍军人也有共同的心理健康诊断，例如 广泛性焦虑症、物质滥用障碍和重度抑郁症。退伍军人创伤后应激障碍的治疗 并存的疾病是一个重要的治疗和康复问题。这种疾病是复杂的 而且很难治疗，高的治疗辍学率和无反应率促使一些退伍军人寻求 相辅相成的综合卫生战略。一个有希望的补充策略是提供训练有素的 服务犬。多个研究小组的初步证据表明，服务犬是一种有希望的补充 以证据为基础的做法可以提供短期的改善。然而，长期的效果是， 作用机制和功效调节因子在很大程度上仍不清楚。因此，总体目标是 这项建议是为了了解创伤后应激障碍服务犬如何、为什么以及对谁最有效。 为了达到这一目标，本项目将评估以下药物的纵向疗效和剂量-反应曲线 为老兵创伤后应激障碍症状和心理社会功能提供服务的狗(目标1)。要了解如何和 为什么干预有效，这个项目还将实施潜在机制的理论驱动的量化 可能调解勤务犬功效的行动(目标2)。最后，要了解为了谁和在什么之下 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效能的调节因素 检查治疗效果的异质性(目标3)。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 对六个数据流进行全面监测，包括：(1)临床医生对创伤后应激障碍的盲目评估 症状学，(2)心理社会功能的标准化调查，(3)对 日常情绪体验和活动，(4)唾液生物标志物的两个主要应激反应系统通过 皮质醇和α-淀粉酶，(5)运动监测的体力活动和睡眠，以及(6) 犬类对行为、性情和与人类伴侣的生理协同调节的评估。结果 预计将阐明服役犬对患有创伤后应激障碍的退伍军人的临床影响，以及 作用的生物行为机制和调节疗效的特征。这些结果将支持 加速补充和综合卫生干预的长期目标，通过优化和 循证服务犬干预。因此，这一项目将进一步推动对 人与动物相互作用对心理社会健康的影响。