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

NCT01729026 | Completed Early Phase 1 Results DMC

• 1 other identifier: D0809-P
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Veterans; Posttraumatic Stress Disorder; dog adoption; companion animal

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up

  The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).

  Baseline and 3-month follow-up visit.

Secondary Outcomes (11)

• Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)

  Baseline and 3-month follow-up

• Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score

  Baseline and 3-month follow-up

• Change in Beck Depression Inventory - II (BDI-II) Score

  Baseline and 3-month follow-up

• Change in Community Integration Questionnaire (CIQ) Total Score

  Baseline and 3-month follow-up visit

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  Baseline and 3-month follow-up

Study Arms (2)

Shelter Dog Adoption

EXPERIMENTAL

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.

Other: Shelter Dog Adoption

Wait-list, Then Adoption after 3 Months

ACTIVE COMPARATOR

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.

Other: Shelter Dog Adoption

Interventions

Shelter Dog Adoption 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.

Shelter Dog Adoption; Wait-list, Then Adoption after 3 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Stephen Stern
• Organization: South Texas Veterans Health Care System; University of Texas Health Science Center at San Antonio

stephen.stern@va.gov; sterns@uthscsa.edu

210-887-3754

Study Officials

• Stephen L. Stern, MD BA

  South Texas Health Care System, San Antonio, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 2, 2020
• Results First Posted: April 27, 2016

Record last verified: 2020-05

Locations

US (1)