Service Dogs for Veterans With PTSD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01329341
First received: March 30, 2011
Last updated: June 23, 2014
Last verified: June 2014
  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
Drug: no intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Mental Health Outcomes [ Time Frame: 3,6,9,12,18 and 24 months after receipt of service dog ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 220
Study Start Date: July 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: January 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
Other Name: Service Dogs
Active Comparator: Arm 2
No service dog
Drug: no intervention
Individuals who do not wish to receive a service dog may be part of the comparison group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Referral from provider.
  • PTSD diagnosis
  • In active therapy for PTSD for at least three months at time of enrollment, with plans to remain in active therapy
  • Acceptance by the dog vendor for the service dog group
  • Ability to adequately care for a dog - for the service dog group
  • Living in Florida

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 use or dependence
  • At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study
  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, Florida, United States, 33637-1022
Sponsors and Collaborators
Investigators
Principal Investigator: Stephanie McGovern, RN James A. Haley Veterans' Hospital, Tampa, FL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01329341     History of Changes
Other Study ID Numbers: D8094-I
Study First Received: March 30, 2011
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
Service Dogs

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014