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Service Dogs for Veterans With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01329341
Recruitment Status : Terminated (Study concluded prematurly)
First Posted : April 5, 2011
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
PTSD Other: Service Dogs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Service Dogs for Veterans With PTSD: A Randomized Clinical Trial
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Service Dogs
 Other: Service Dogs
Service dogs will be trained to help Veterans with PTSD


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329341


Locations
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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
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Principal Investigator: Stephanie McGovern, RN James A. Haley Veterans' Hospital, Tampa, FL
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] November 26, 2014

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01329341    
Other Study ID Numbers: D8094-I
First Posted: April 5, 2011    Key Record Dates
Results First Posted: July 9, 2021
Last Update Posted: July 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders