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.

项目总结/文摘