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

This study has been completed.
Sponsor:
Collaborator:
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01729026
First received: November 13, 2012
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Posttraumatic Stress Disorder (PTSD)
Other: Shelter Dog Adoption
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up [ Time Frame: Baseline and 3-month follow-up visit. ] [ Designated as safety issue: No ]
    PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).


Secondary Outcome Measures:
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS) [ Time Frame: The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups. ] [ Designated as safety issue: No ]
    The administration of the CAPS will ensure that participants meet criteria for current PTSD

  • Alcohol Use Disorders Identification Test (AUDIT-C) [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the frequency and extent of alcohol use

  • Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the frequency and severity of common symptoms of depression

  • Community Integration Questionnaire (CIQ) [ Time Frame: Baseline and 3-month and 6-month follow-up visits ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the extent of a subject's integration into her or his community

  • MINI International Neuropsychiatric Inventory (MINI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode

  • Physical Activity Questionnaire (PAQ) [ Time Frame: Baseline and 3-month and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.

  • Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) [ Time Frame: Baseline and 3-month and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD

  • Semi-Structured Interview [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls ] [ Designated as safety issue: No ]
    Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog

  • UCLA Loneliness Scale, Version 3 [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale to assess symptoms of loneliness

  • Veterans RAND 12-item Health Survey (VR-12) [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assess physical and mental aspects of health-related quality of life

  • Numeric Rating Scale for Pain Intensity [ Time Frame: Baseline and 3-month and 6-month follow-up ] [ Designated as safety issue: No ]
    Self-rating scale that assesses pain severity


Enrollment: 19
Study Start Date: October 2013
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Active Comparator: 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.
Other: 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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729026

Locations
United States, Texas
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
VA Office of Research and Development
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Stephen L. Stern, MD BA South Texas Health Care System, San Antonio, TX
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01729026     History of Changes
Other Study ID Numbers: D0809-P 
Study First Received: November 13, 2012
Results First Received: February 23, 2016
Last Updated: April 26, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Veterans
Posttraumatic Stress Disorder
dog adoption
companion animal

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

ClinicalTrials.gov processed this record on July 28, 2016