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

Information

  • Research Project
  • 10308302
  • ApplicationId
    10308302
  • Core Project Number
    R01HD106413
  • Full Project Number
    1R01HD106413-01
  • Serial Number
    106413
  • FOA Number
    PAR-20-031
  • Sub Project Id
  • Project Start Date
    9/7/2021 - 4 years ago
  • Project End Date
    8/31/2026 - 7 months from now
  • Program Officer Name
    ESPOSITO, LAYLA E
  • Budget Start Date
    9/7/2021 - 4 years ago
  • Budget End Date
    8/31/2022 - 3 years ago
  • Fiscal Year
    2021
  • Support Year
    01
  • Suffix
  • Award Notice Date
    9/7/2021 - 4 years ago
Organizations

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

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.

IC Name
EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
  • Activity
    R01
  • Administering IC
    HD
  • Application Type
    1
  • Direct Cost Amount
    447880
  • Indirect Cost Amount
    226702
  • Total Cost
    674582
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    865
  • Ed Inst. Type
    SCHOOLS OF NURSING
  • Funding ICs
    NICHD:674582\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZHD1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    PURDUE UNIVERSITY
  • Organization Department
    NONE
  • Organization DUNS
    072051394
  • Organization City
    WEST LAFAYETTE
  • Organization State
    IN
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    479072114
  • Organization District
    UNITED STATES