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Trial record 44 of 5439 for:    veterans

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01729026
Recruitment Status : Completed
First Posted : November 20, 2012
Results First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder (PTSD)
Intervention Other: Shelter Dog Adoption
Enrollment 19
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 Details 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
Hide 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
Reason Not Completed
Lost to Follow-up             2             2
Period Title: 3-month to 6-month (Final) Follow-up
Started 7 8
Completed 6 6
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title Shelter Dog Adoption Wait-list, Then Adoption After 3 Months Total
Hide 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 Number of Baseline Participants 9 10 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 19 participants
45.0  (13.8) 39.2  (11.4) 42.1  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Female
3
  33.3%
5
  50.0%
8
  42.1%
Male
6
  66.7%
5
  50.0%
11
  57.9%
1.Primary Outcome
Title Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
Hide Description PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
Time Frame Baseline and 3-month follow-up visit.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Shelter Dog Adoption Wait-list, Then Adoption After 3 Months
Hide 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.

Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: units on a scale
15.2  (3.5) 7.8  (3.3)
Show Statistical Analysis 1 Hide 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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1414
Comments Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.2 points on the PCL-5 compared to 7.8 points in the Wait-list group.
Method Mixed effects regression models
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size (Cohen's d)
Estimated Value 0.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinician-Administered PTSD Scale for DSM-5 (CAPS)
Hide Description The administration of the CAPS will ensure that participants meet criteria for current PTSD
Time Frame The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Alcohol Use Disorders Identification Test (AUDIT-C)
Hide Description Self-rating scale that assesses the frequency and extent of alcohol use
Time Frame Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Beck Depression Inventory - II (BDI-II)
Hide Description Self-rating scale that assesses the frequency and severity of common symptoms of depression
Time Frame Baseline and 1-month, 3-month, 4-month, and 6-month follow-up
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Community Integration Questionnaire (CIQ)
Hide Description Self-rating scale that assesses the extent of a subject's integration into her or his community
Time Frame Baseline and 3-month and 6-month follow-up visits
Outcome Measure Data Not Reported
6.Secondary Outcome
Title MINI International Neuropsychiatric Inventory (MINI)
Hide Description Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patient Health Questionnaire-9 (PHQ-9)
Hide Description Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode
Time Frame Baseline and 1-month, 3-month, 4-month, and 6-month follow-up
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Physical Activity Questionnaire (PAQ)
Hide Description Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.
Time Frame Baseline and 3-month and 6-month follow-up
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
Hide Description Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD
Time Frame Baseline and 3-month and 6-month follow-up
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Semi-Structured Interview
Hide 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 Not Reported
11.Secondary Outcome
Title UCLA Loneliness Scale, Version 3
Hide Description Self-rating scale to assess symptoms of loneliness
Time Frame Baseline and 1-month, 3-month, 4-month, and 6-month follow-up
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Veterans RAND 12-item Health Survey (VR-12)
Hide Description Self-rating scale that assess physical and mental aspects of health-related quality of life
Time Frame Baseline and 1-month, 3-month, 4-month, and 6-month follow-up
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Numeric Rating Scale for Pain Intensity
Hide Description Self-rating scale that assesses pain severity
Time Frame Baseline and 3-month and 6-month follow-up
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Shelter Dog Adoption Wait-list, Then Adoption After 3 Months
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Shelter Dog Adoption Wait-list, Then Adoption After 3 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Shelter Dog Adoption Wait-list, Then Adoption After 3 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/9 (55.56%)      4/10 (40.00%)    
Psychiatric disorders     
Emotional distress - reasons given under Additional Description  [1]  5/9 (55.56%)  5 4/10 (40.00%)  6
Indicates events were collected by systematic assessment
[1]
wished dog had more room to run, worried dog was at home alone, unhappy was assigned to wait-list, dog chewed up things, dog dug up yard, dog too energetic, dog smelled bad, dog growled (2), dog had medical problems (2)
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.
Results Point of Contact
Name/Title: Dr. Stephen Stern
Organization: South Texas Veterans Health Care System; University of Texas Health Science Center at San Antonio
Phone: 210-887-3754
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01729026     History of Changes
Other Study ID Numbers: D0809-P
First Submitted: November 13, 2012
First Posted: November 20, 2012
Results First Submitted: February 23, 2016
Results First Posted: April 27, 2016
Last Update Posted: April 27, 2016