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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01729026
• Collaborator: The University of Texas Health Science Center at San Antonio (Other)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Other: Shelter Dog Adoption	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up [Baseline and 3-month follow-up visit.]

   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

1. Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) [Baseline and 3-month follow-up]

   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).

2. Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score [Baseline and 3-month follow-up]

   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).

3. Change in Beck Depression Inventory - II (BDI-II) Score [Baseline and 3-month follow-up]

   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).

4. Change in Community Integration Questionnaire (CIQ) Total Score [Baseline and 3-month follow-up visit]

   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.

5. Change in Patient Health Questionnaire-9 (PHQ-9) Score [Baseline and 3-month follow-up]

   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).

6. Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ) [Baseline and 3-month follow-up]

   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.

7. Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A) [Baseline and 3-month follow-up]

   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).

8. Number of Participants With Improvement in Quality of Life After Dog Adoption [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]

   Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog

9. Change in Scores on the UCLA Loneliness Scale, Version 3 [Baseline and 3-month follow-up]

   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).

10. Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12) [Baseline and 3-month Follow-up]

    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).

11. Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS) [Baseline and 3-month follow-up]

    The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Texas Health Care System, San Antonio, TX	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• VA Office of Research and Development
• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Stephen L. Stern, MD BA, South Texas Health Care System, San Antonio, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01729026
• Other Study ID Numbers: D0809-P
• First Posted: Nov 20, 2012
• Last Update Posted: Jun 2, 2020
• Last Verified: May 1, 2020

• Keywords provided by VA Office of Research and Development: Veterans; Posttraumatic Stress Disorder; dog adoption; companion animal
• Additional relevant MeSH terms: Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	Enrollment opened in October 2013 and closed at the end of September 2014. Subjects learned about the study primarily from clinical staff or from posters and brochures that were distributed throughout the clinics of the South Texas Veterans Health Care System in San Antonio.
Pre-assignment Detail	Two of the 22 consented subjects were not randomized: one left before he was evaluated and the second did not meet entry criteria. A third subject was randomized to the Adoption group but subsequently found not to meet criteria for PTSD, leaving 9 in this group and 10 in the Wait-List group.

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Period Title: Randomization to 3-month Follow-up
STARTED	9	10
COMPLETED	7	8
NOT COMPLETED	2	2
Period Title: Randomization to 3-month Follow-up
STARTED	7	8
COMPLETED	6	6
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months	Total
Arm/Group 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. 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.	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. 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.	Total of all reporting groups
Overall Participants	9	10	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (13.8)	39.2 (11.4)	42.1 (12.6)
Sex: Female, Male (Count of Participants)
Female	3 33.3%	5 50%	8 42.1%
Male	6 66.7%	5 50%	11 57.9%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-15.20 (3.52)	-7.77 (3.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments	The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.141
	Comments	Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.
	Method	Mixed effects regression models
	Comments
Method of Estimation	Estimation Parameter	Effect size (Cohen's d)
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -1.85 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	1.4 (3.0)	1.5 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.982
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-0.5 (0.6)	0.7 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.160
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-6.41 (1.72)	-0.19 (1.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	-1.36
	Confidence Interval	(2-Sided) 95%; -2.49 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	2.9 (1.1)	2.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-4.07 (1.20)	0.71 (1.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	mixed effects regression models
	Estimated Value	-1.41
	Confidence Interval	(2-Sided) 95%; -2.50 to -0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Number [percent of participants]	40 444.4%	33 330%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-1.3 (1.4)	1.3 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.188
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who had a dog for 3 months.

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	6	4
Count of Participants [Participants]	5 55.6%	4 40%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-7.8 (3.5)	3.4 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	mixed effects regression models
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.	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. 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.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	6.01 (4.34)	2.30 (4.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.541
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; -0.80 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shelter Dog Adoption	Wait-list, Then Adoption After 3 Months
Arm/Group Description	Veterans will choose a dog from the San Antonio Humane Society with the help of a San Antonio 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 8 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 San Antonio 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 8 weeks of free obedience training by a veterinarian.
Measure Participants	9	10
Mean (Standard Error) [units on a scale]	-0.1 (0.7)	-1.6 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shelter Dog Adoption, Wait-list, Then Adoption After 3 Months
	Comments	Please note that a minus number indicates an increase in pain ratings.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.139
	Comments
	Method	effect size (Cohen's d)
	Comments
Method of Estimation	Estimation Parameter	effect size (Cohen's d)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Shelter Dog Adoption		Wait-list, Then Adoption After 3 Months
Arm/Group 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. 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.		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. 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.
All Cause Mortality
	Shelter Dog Adoption		Wait-list, Then Adoption After 3 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Shelter Dog Adoption		Wait-list, Then Adoption After 3 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Shelter Dog Adoption		Wait-list, Then Adoption After 3 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/9 (55.6%)		4/10 (40%)
Psychiatric disorders
Emotional distress - reasons given under Additional Description	5/9 (55.6%)	5	4/10 (40%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.