Service Dogs for Veterans With PTSD

NCT01329341 | Terminated Results DMC

• 1 other identifier: D8094-I
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

PTSD; Service Dogs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

Service Dogs

Other: Service Dogs

Interventions

Service Dogs OTHER

Service dogs will be trained to help Veterans with PTSD

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Study was terminated but a subsequent multisite clinical trial (NCT02039843) was completed.

Results Point of Contact

• Title: Stephanie McGovern
• Organization: James A Haley Veterans Hospital

stephanie.mcgovern@va.gov

813-558-3964

Study Officials

• Stephanie McGovern, RN

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 5, 2011
• Study Start: July 1, 2011
• Primary Completion: January 31, 2017
• Study Completion: March 31, 2017
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)