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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
San Antonio Humane Society
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01729026
First received: November 13, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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 Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD Checklist (PCL-5) [ Time Frame: Phone screen, baseline, and 1-month, 3-month, 4-month, and 6-month follow-up visits. The 4-month follow-up will be conducted only for subjects in the wait-list control group. ] [ Designated as safety issue: No ]
    PCL-5 a self rating scale based on the DSM-5 diagnostic criteria


Secondary Outcome Measures:
  • CAPS [ Time Frame: The CAPS will be administered at the baseline, 3-month, and 6-month visits. ] [ 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

  • Semi Structured Interview [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups ] [ Designated as safety issue: No ]
    Inquires about various aspects of subjects' interactions with their dog

  • 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 visits ] [ 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 visits ] [ 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 visits ] [ 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 experience related to have a dog

  • UCLA Loneliness Scale, Version 3 [ Time Frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits ] [ 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 visits ] [ 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 visits ] [ Designated as safety issue: No ]
    Self-rating scale that assesses pain severity


Estimated Enrollment: 48
Study Start Date: October 2013
Estimated Study Completion Date: March 2015
Estimated 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-5 criteria for current PTSD as determined by the CAPS
  • Scores 39 or greater on the PCL-5
  • Feels able to afford to care for a dog after the anticipated annual costs of approximately $750 are outlined
  • If married or cohabitating, 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
  • Had a dog previously as a child or adult
  • Served during the Vietnam era or more recently
  • In active therapy for at least three months, with plans to remain in active therapy

Exclusion Criteria:

  • Has had a dog or other companion animal within the past 12 months
  • Has current alcohol or drug abuse or dependence, as assessed on the MINI or clinical interview
  • Has a primary psychiatric diagnosis other than PTSD
  • Has had significant suicide risk in the past 3 months on the MINI or by clinical interview
  • Has had psychosis or mania in the past 3 months on the MINI or by clinical interview
  • Has had a psychiatric admission during the past 6 months
  • Has mental or physical impairments that would interfere with caring for the dog or self or with participating in the study
  • Has a history of moderate to severe traumatic brain injury
  • 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 physiatrist 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

Contacts
Contact: Ana Allegretti, PhD (210) 617-5300 ext 16079 AnaLuiza.Allegretti@va.gov
Contact: Sara E Stamets, BA (210) 562-6724 stamets@uthscsa.edu

Locations
United States, Texas
South Texas Health Care System, San Antonio, TX Recruiting
San Antonio, Texas, United States, 78229
Contact: Stephen L Stern, MD BA       stephen.stern@va.gov   
Principal Investigator: Stephen L. Stern, MD BA         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
San Antonio Humane Society
Investigators
Principal Investigator: Stephen L. Stern, MD BA South Texas Health Care System, San Antonio, TX
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01729026     History of Changes
Other Study ID Numbers: D0809-P
Study First Received: November 13, 2012
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Veterans
Posttraumatic Stress Disorder
dog adoption
companion animal

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014