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
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
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
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
NCT ID
NCT05900479
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)
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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