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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: January 8, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Mental Health
U.S. FDA Resources

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: 350
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (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 at least three months at time of study for PTSD, with plans to remain in active therapy
  • Acceptance by the dog agencies for the service dog group
  • Ability to adequately care for a dog - for the service dog group
  • Living in Florida and within 150 miles of Williston, Florida - for service dog group

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 entry - Past or Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study
  Contacts and Locations
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
Department of Veterans Affairs
Investigators
Principal Investigator: Shirley Groer, PhD MS James A. Haley Veterans Hospital
  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: January 8, 2013
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 May 21, 2013