Early Phase 1
N=19
A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder (PTSD)
Bottom Line
View on ClinicalTrials.gov: NCT01729026 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up — -15.20; -7.77 units on a scale — p=0.141
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Shelter Dog Adoption (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up |
-15.20; -7.77 | 0.141 |
| SECONDARY Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) |
1.4; 1.5 | 0.982 |
| SECONDARY Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score |
-0.5; 0.7 | 0.160 |
| SECONDARY Change in Beck Depression Inventory - II (BDI-II) Score |
-6.41; -0.19 | 0.015 sig |
| SECONDARY Change in Community Integration Questionnaire (CIQ) Total Score |
2.9; 2.1 | 0.59 |
| SECONDARY Change in Patient Health Questionnaire-9 (PHQ-9) Score |
-4.07; 0.71 | 0.010 sig |
| SECONDARY Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ) |
40; 33 | 0.13 |
| SECONDARY Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) |
-1.3; 1.3 | 0.188 |
| SECONDARY Number of Participants With Improvement in Quality of Life After Dog Adoption |
5; 4 | — |
| SECONDARY Change in Scores on the UCLA Loneliness Scale, Version 3 |
-7.8; 3.4 | 0.031 sig |
| SECONDARY Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12) |
6.01; 2.30 | 0.541 |
| SECONDARY Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS) |
-0.1; -1.6 | 0.139 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01729026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.