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

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Shelter Dog Adoption
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring Veterans, Posttraumatic Stress Disorder, dog adoption, companion animal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Texas Health Care System, San Antonio, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shelter Dog Adoption

Wait-list, Then Adoption after 3 Months

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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.
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).
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.
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).
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
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).
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).
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)

Full Information

First Posted
November 13, 2012
Last Updated
May 26, 2020
Sponsor
VA Office of Research and Development
Collaborators
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT01729026
Brief Title
A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)
Acronym
VITAL
Official Title
A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
Veterans, Posttraumatic Stress Disorder, dog adoption, companion animal

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shelter Dog Adoption
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list, Then Adoption after 3 Months
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Shelter Dog Adoption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
Description
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).
Time Frame
Baseline and 3-month follow-up visit.
Secondary Outcome Measure Information:
Title
Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Change in Beck Depression Inventory - II (BDI-II) Score
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Change in Community Integration Questionnaire (CIQ) Total Score
Description
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.
Time Frame
Baseline and 3-month follow-up visit
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)
Description
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.
Time Frame
Baseline and 3-month follow-up
Title
Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Number of Participants With Improvement in Quality of Life After Dog Adoption
Description
Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog
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
Title
Change in Scores on the UCLA Loneliness Scale, Version 3
Description
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).
Time Frame
Baseline and 3-month follow-up
Title
Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)
Description
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).
Time Frame
Baseline and 3-month Follow-up
Title
Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)
Description
The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)
Time Frame
Baseline and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L. Stern, MD BA
Organizational Affiliation
South Texas Health Care System, San Antonio, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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