Service Dogs for Veterans With PTSD

PTSD Clinical Trial

Official title:

Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329341
• Other study ID #: D8094-I
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2011
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Other:
• Service Dogs
Service dogs will be trained to help Veterans with PTSD

Locations

Country	Name	City	State
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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