Posttraumatic Stress Disorder (PTSD)Early Phase 1VITALNCT01729026
A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)
A Early Phase 1 study testing Shelter Dog Adoption in people with Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Shelter Dog Adoption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2015
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Shelter Dog Adoption
- Keywords
- Veterans, Posttraumatic Stress Disorder, dog adoption, companion animal
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shelter Dog AdoptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shelter Dog Adoption | Experimental | 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. Receives: Other: Shelter Dog Adoption |
| Wait-list, Then Adoption after 3 Months | Active comparator | 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. Receives: Other: Shelter Dog Adoption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 3-month follow-up visit.
Secondary outcomes (11)
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).
Measured: Baseline and 3-month follow-up
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).
Measured: Baseline and 3-month follow-up
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).
Measured: Baseline and 3-month follow-up
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.
Measured: Baseline and 3-month follow-up visit
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).
Measured: Baseline and 3-month follow-up
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.
Measured: Baseline and 3-month follow-up
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).
Measured: Baseline and 3-month follow-up
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
Measured: 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
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).
Measured: Baseline and 3-month follow-up
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).
Measured: Baseline and 3-month Follow-up
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)
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen L. Stern, MD BA, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729026
- Sponsor's protocol ID
- D0809-P
- Acronym
- VITAL
- Status last verified
- May 2020
- First submitted
- 13 Nov 2012
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01729026
- Acronym / sponsor ID
- VITAL / D0809-P
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Veterans, Posttraumatic Stress Disorder, dog adoption, companion animal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Posted 27 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shelter Dog Adoption | Experimental | Other: Shelter Dog AdoptionVeterans 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. |
| Wait-list, Then Adoption after 3 Months | Active comparator | Other: Shelter Dog AdoptionAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shelter Dog AdoptionVeterans 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. | Other | Shelter Dog Adoption, Wait-list, Then Adoption after 3 Months |
Primary outcome
Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
Time frame: 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).
11 secondary outcomes
Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
Time frame: Baseline and 3-month follow-up
Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score
Time frame: Baseline and 3-month follow-up
Change in Beck Depression Inventory - II (BDI-II) Score
Time frame: Baseline and 3-month follow-up
Change in Community Integration Questionnaire (CIQ) Total Score
Time frame: Baseline and 3-month follow-up visit
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and 3-month follow-up
Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)
Time frame: Baseline and 3-month follow-up
Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
Time frame: Baseline and 3-month follow-up
Number of Participants With Improvement in Quality of Life After Dog Adoption
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
Change in Scores on the UCLA Loneliness Scale, Version 3
Time frame: Baseline and 3-month follow-up
Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)
Time frame: Baseline and 3-month Follow-up
Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)
Time frame: Baseline and 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L. Stern, MD BA principal investigator
South Texas Health Care System, San Antonio, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Shelter Dog Adoption in people with Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up (time frame: Baseline and 3-month follow-up visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.