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Service Dogs for Veterans With PTSD

This study has been terminated.
(Study concluded prematurly)
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01329341
First received: March 30, 2011
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
PTSD Other: Service Dogs

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Mental Health Outcomes [ Time Frame: 3,6,9,12,18 and 24 months after receipt of service dog ]
    Mental Health Outcomes are defined by the following measures: (PCL-S - PTSD symptoms; Depression - measured by PHQ9; and Alcohol abuse - measured by the Audit-C)


Enrollment: 62
Actual Study Start Date: July 1, 2011
Study Completion Date: March 31, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Service Dogs
Other: Service Dogs
Service dogs will be trained to help Veterans with PTSD

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Living in Florida
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329341

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Stephanie McGovern, RN James A. Haley Veterans' Hospital, Tampa, FL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01329341     History of Changes
Other Study ID Numbers: D8094-I
Study First Received: March 30, 2011
Last Updated: May 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
PTSD
Service Dogs

ClinicalTrials.gov processed this record on August 18, 2017