Service Dogs for Veterans With PTSD

Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Other: Service Dogs

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans' Hospital, Tampa, FL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 18 years
• Referral from provider.
• PTSD diagnosis
• In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment
• Acceptance by the dog vendor for the service dog
• Ability to adequately care for a dog - physically/financially
• Able to travel to vendor for pairing with dog

Exclusion Criteria:

• Been hospitalized for mental health reasons in the prior 6 months
• Not living at the same residence for 6 months.
• Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent
• At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study.
• Children under age 10 living in the home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Service Dogs	Other: Service Dogs; Service dogs will be trained to help Veterans with PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Outcomes	Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms	3,6,9,12,18 and 24 months after receipt of service dog

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Stephanie McGovern, RN, James A. Haley Veterans' Hospital, Tampa, FL

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; Service Dogs
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: D8094-I

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
• product manufactured in and exported from the U.S.: No