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Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

Primary Purpose

Stress Disorders, Post-Traumatic, Combat Stress Disorders, Animal-Human Bonding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PTSD Service Dog
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Applied for and approved to receive a psychiatric service dog from Canine Companions or K9s For Warriors Military service Honorable discharge or current honorable service Diagnosis of PTSD No conviction of any crimes against animals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PTSD Service Dog

    Usual Care

    Arm Description

    Outcomes

    Primary Outcome Measures

    PTSD Severity and symptoms via self-report
    Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5, Range 0-80, Lower scores indicate a better outcome)

    Secondary Outcome Measures

    PTSD Severity and symptoms via blinded clinician rating
    Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5-R, Range 0-80, Lower scores indicate a better outcome)
    Depression
    Patient Health Questionnaire (PHQ-9, Range 1-27, Lower scores indicate a better outcome)
    Anxiety
    Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety 8a (Raw Score Range 8-40, Lower scores indicate a better outcome)

    Full Information

    First Posted
    June 2, 2023
    Last Updated
    June 12, 2023
    Sponsor
    University of Arizona
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05900479
    Brief Title
    Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD
    Official Title
    Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2028 (Anticipated)
    Study Completion Date
    August 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Arizona
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments at 0, 3, 9, and 15 months. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Disorders, Post-Traumatic, Combat Stress Disorders, Animal-Human Bonding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PTSD Service Dog
    Arm Type
    Experimental
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    PTSD Service Dog
    Other Intervention Name(s)
    PTSD Assistance Dog
    Intervention Description
    According to the Americans with Disabilities Act (ADA), a service dog is a dog that is trained to perform specific tasks to mitigate a disability. For PTSD service dogs, examples include detecting and alerting to physical signs of distress to interrupt anxiety and panic attacks, waking up Veterans from nightmares, and retrieving medication. In addition to trained tasks, service dogs live with the Veterans to provide emotional value as a source of comfort and companionship. Under the ADA guidance, PTSD service dogs have pubic access and are legally allowed to accompany their person in public places such as grocery stores, workplaces, and schools. In the proposed study, service dogs will be sourced from two Assistance Dog International (ADI) accredited providers, including K9s For Warriors and Canine Companions for Independence. Both providers have an established track record of training and providing PTSD service dogs, as well as collaborating with the investigative team in research.
    Primary Outcome Measure Information:
    Title
    PTSD Severity and symptoms via self-report
    Description
    Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5, Range 0-80, Lower scores indicate a better outcome)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    PTSD Severity and symptoms via blinded clinician rating
    Description
    Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5-R, Range 0-80, Lower scores indicate a better outcome)
    Time Frame
    12 months
    Title
    Depression
    Description
    Patient Health Questionnaire (PHQ-9, Range 1-27, Lower scores indicate a better outcome)
    Time Frame
    12 months
    Title
    Anxiety
    Description
    Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety 8a (Raw Score Range 8-40, Lower scores indicate a better outcome)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Applied for and approved to receive a psychiatric service dog from Canine Companions or K9s For Warriors Military service Honorable discharge or current honorable service Diagnosis of PTSD No conviction of any crimes against animals
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maggie O'Haire, PhD
    Phone
    520-621-5126
    Email
    maggieohaire@arizona.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

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