Clinical trial NCT01729026: A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)
Official title: A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Veterans
Posttraumatic Stress Disorder
dog adoption
companion animal
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2012-11-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
timeFrame: Baseline and 3-month follow-up visit.
Secondary outcomes:
measure: Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
timeFrame: Baseline and 3-month follow-up
measure: Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score
timeFrame: Baseline and 3-month follow-up
measure: Change in Beck Depression Inventory - II (BDI-II) Score
timeFrame: Baseline and 3-month follow-up
measure: Change in Community Integration Questionnaire (CIQ) Total Score
timeFrame: Baseline and 3-month follow-up visit
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Baseline and 3-month follow-up
measure: Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)
timeFrame: Baseline and 3-month follow-up
measure: Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
timeFrame: Baseline and 3-month follow-up
measure: Number of Participants With Improvement in Quality of Life After Dog Adoption
timeFrame: 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
measure: Change in Scores on the UCLA Loneliness Scale, Version 3
timeFrame: Baseline and 3-month follow-up
measure: Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)
timeFrame: Baseline and 3-month Follow-up
measure: Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: South Texas Health Care System, San Antonio, TX
name: Stephen L. Stern, MD BA
role: PRINCIPAL_INVESTIGATOR
References: