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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

— VITAL  

Official title:

A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729026
• Other study ID #: D0809-P
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)	The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).	Baseline and 3-month follow-up
Secondary	Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score	Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).	Baseline and 3-month follow-up
Secondary	Change in Beck Depression Inventory - II (BDI-II) Score	The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).	Baseline and 3-month follow-up
Secondary	Change in Community Integration Questionnaire (CIQ) Total Score	Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.	Baseline and 3-month follow-up visit
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9) Score	The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).	Baseline and 3-month follow-up
Secondary	Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)	The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.	Baseline and 3-month follow-up
Secondary	Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)	Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).	Baseline and 3-month follow-up
Secondary	Number of Participants With Improvement in Quality of Life After Dog Adoption	Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog	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
Secondary	Change in Scores on the UCLA Loneliness Scale, Version 3	The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).	Baseline and 3-month follow-up
Secondary	Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)	The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).	Baseline and 3-month Follow-up
Secondary	Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)	The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)	Baseline and 3-month follow-up