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Service Dogs for Veterans With PTSD

Primary Purpose

PTSD

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Service Dogs
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PTSD focused on measuring PTSD, Service Dogs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Service Dogs

Outcomes

Primary Outcome Measures

Mental Health Outcomes
Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms

Secondary Outcome Measures

Full Information

First Posted
March 30, 2011
Last Updated
June 17, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01329341
Brief Title
Service Dogs for Veterans With PTSD
Official Title
Service Dogs for Veterans With PTSD: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Study concluded prematurly
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Service Dogs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Service Dogs
Intervention Type
Other
Intervention Name(s)
Service Dogs
Intervention Description
Service dogs will be trained to help Veterans with PTSD
Primary Outcome Measure Information:
Title
Mental Health Outcomes
Description
Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms
Time Frame
3,6,9,12,18 and 24 months after receipt of service dog

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie McGovern, RN
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Service Dogs for Veterans With PTSD

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