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

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).

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Service Dog

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Service Dog; Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.	Behavioral: Service Dog; A service dog trained to perform tasks that are specific to PTSD
No Intervention: Waitlist Control; 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); range 0-80; higher scores indicate worse outcome.	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); range 0-80; higher scores indicate worse outcome.	3 months
Depression	Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.	3 months
Anxiety	Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.	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; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.	3 months
Companionship	Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome	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; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome.	3 months
Mental Health Quality of Life	Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome.	3 months
Psychological Well-being	Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.	3 months
Life Satisfaction	Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome.	3 months
Resilience	Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome.	3 months
Anger	Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.	3 months
Daily Socio-emotional Experiences	Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work and Activity Participation	Work Productivity and Activity Impairment Questionnaire (WPAIQ)	3 months
Suicidal Ideation	Columbia Suicide Severity Rating Scale (CSSRS)	3 months
Sleep Quality	Pittsburgh Sleep Quality Assessment (PSQI)	3 months
Sleep Disturbance	Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a	3 months
Sleep Actigraphy	Actiwatch 2 (Philips Respironics)	3 months
Salivary Cortisol Awakening Response	Passive drool method (Salimetrics)	3 months
Electrodermal Activity (Skin Conductance)	Embrace wristband (Empatica, Inc.)	3 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Marguerite O'Haire, Ph.D., University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: human-animal interaction; service dogs
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1R21HD091896-01 (U.S. NIH Grant/Contract); R21HD091896-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No