Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).

Detailed Description
-----------------
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.

Official Title
-----------------
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Service Dog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for veterans into the study will include: Applied for and approved to receive a dog from K9s For Warriors Military service on or after September 11, 2001 Honorable discharge or current honorable service Diagnosis of PTSD No conviction of any crimes against animals.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Service Dog<br>Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog. | Behavioral: Service Dog<br>* A service dog trained to perform tasks that are specific to PTSD<br>|
| No Intervention: Waitlist Control<br>Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD severity and symptoms via self-report | Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) | 3 months | 
| PTSD severity and symptoms via clinician rating | Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5) | 3 months | 
| Depression | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a | 3 months | 
| Anxiety | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social isolation | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a | 3 months | 
| Companionship | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a | 3 months | 
| Ability to participate in social activities | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a | 3 months | 
| Mental health quality of life | Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component | 3 months | 
| Psychological well-being | Bradburn Scale of Psychological Wellbeing (BSPW) | 3 months | 
| Life satisfaction | Satisfaction with Life Scale (SLS) | 3 months | 
| Resilience | Connor-Davidson Resilience Scale (CDRS) | 3 months | 
| Anger | Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a | 3 months | 
| Daily socio-emotional experiences | Ecological momentary assessment (EMA) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
service dogs, human-animal interaction