A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)

NCT ID: NCT01729026

Last Updated: 2020-06-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to provide preliminary data on the feasibility and impact of adopting a dog from an animal shelter as a supplement to usual care in Veterans with Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.

Detailed Description

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Posttraumatic Stress Disorder, a common mental disorder among Veterans, is marked by painful re-experiencing of a traumatic event, often together with depression, fearfulness, and social isolation. Despite major advances in rehabilitation, many Veterans continue to be disabled by PTSD. One possible new approach involves the use of shelter dogs, which might relieve symptoms and aid reintegration into society by providing emotional support and a greater sense of security. In this randomized controlled trial of 48 Veterans with chronic PTSD, we will evaluate whether the half who adopt a dog from the San Antonio Humane Society show greater improvement in their PTSD symptoms over the first three months than the half who are assigned to a waiting list.

Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Shelter Dog Adoption

Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.

Group Type EXPERIMENTAL

Shelter Dog Adoption

Intervention Type OTHER

Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.

Wait-list, Then Adoption after 3 Months

After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.

Group Type ACTIVE_COMPARATOR

Shelter Dog Adoption

Intervention Type OTHER

Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.

Interventions

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Shelter Dog Adoption

Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meets Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
* Scores 39 or greater on the PTSD Checklist for DSM-5 (PCL-5)
* Feels able to afford to care for a dog after the anticipated annual costs of approximately $750 are outlined
* If married or cohabiting, spouse or significant other agrees with the decision to adopt a dog
* If not a homeowner, landlady or landlord agrees to allow the dog to reside on the property
* Agrees to keep the dog inside most of the time
* Agrees to be the primary caretaker for the dog
* Had a dog previously as a child or adult
* Served during the Vietnam era or more recently
* In active therapy for at least 1 month, with plans to remain in active therapy
* Has been in a stable housing situation for the last 3 months
* Case manager for any Veteran who is in the Housing and Urban Development/VA Subsidized Housing (HUD/VASH) program has been consulted prior to study enrollment
* Has a plan for someone else to take care of the dog if she or he can't

Exclusion Criteria

* Has had a dog or other companion animal within the past 12 months
* Has current alcohol or drug abuse or dependence
* Has a primary psychiatric diagnosis other than PTSD
* Has had significant suicide/homicide risk in the past 3 months
* Has had psychosis or mania in the past 3 months
* Has had a psychiatric admission during the past 3 months
* Has mental or physical impairments that would interfere with caring for the dog or self
* Has a history of moderate to severe traumatic brain injury (TBI) (subjects with moderate TBI will be allowed to participate in the study if a Physical Medicine and Rehabilitation physician determines it is acceptable)
* Requires a puppy
* Requires a breed that is uncommonly available for adoption at the San Antonio Humane Society
* Requires a pit bull or other fierce dog
* Veteran's mental health clinician or Physical Medicine and Rehabilitation physician reports a past history of animal cruelty or abuse or expresses concern about the potential for such behavior
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen L. Stern, MD BA

Role: PRINCIPAL_INVESTIGATOR

South Texas Health Care System, San Antonio, TX

Locations

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South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D0809-P

Identifier Type: -

Identifier Source: org_study_id

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