Post Traumatic Stress DisorderNCT03245814
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
A study testing Service Dog in people with Post Traumatic Stress Disorder, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Service Dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 4 Jun 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria for veterans into the study will include:
- Applied for and approved to receive a dog from K9s For Warriors
- Military service on or after September 11, 2001
- Honorable discharge or current honorable service
- Diagnosis of PTSD
- No conviction of any crimes against animals.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).
Read the detailed description
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Service Dog
- Keywords
- service dogs, human-animal interaction
- Medical subject headings
- Stress Disorders, Post-Traumatic, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service DogBehavioural
A service dog trained to perform tasks that are specific to PTSD
| Study group | Role | What they receive |
|---|---|---|
| Service Dog | Experimental | Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog. Receives: Behavioral: Service Dog |
| Waitlist Control | No intervention | Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Severity and Symptoms Via Self-report
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.
Measured: 3 months
PTSD Severity and Symptoms Via Clinician Rating
Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome.
Measured: 3 months
Depression
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Measured: 3 months
Anxiety
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Measured: 3 months
Secondary outcomes (9)
Social Isolation
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Measured: 3 months
Companionship
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome
Measured: 3 months
Ability to Participate in Social Activities
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome.
Measured: 3 months
Mental Health Quality of Life
Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome.
Measured: 3 months
Psychological Well-being
Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.
Measured: 3 months
Life Satisfaction
Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome.
Measured: 3 months
Resilience
Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome.
Measured: 3 months
Anger
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Measured: 3 months
Daily Socio-emotional Experiences
Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Jul 2017
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Maggie O'Haire, University of Arizona
- Investigators
- Marguerite O'Haire, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245814
- Sponsor's protocol ID
- 1R21HD091896-01
- Other IDs
- R21HD091896-01
- Status last verified
- Oct 2024
- First submitted
- 5 Jul 2017
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Baus JJ, Ashbeck EL, Brown EA, Mehl MR, Taylor DJ, van Marle K, Schwichtenberg AJ, Bedrick EJ, O'Haire ME. Sleep-wake dynamics in veteran-service dog dyads: an exploration of overnight concordance. Sleep. 2025 Nov 10;48(11):zsaf177. doi: 10.1093/sleep/zsaf177.
PubMed 40580066Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Davis LW, Ashbeck EL, Bedrick EJ, O'Haire ME. Service Dogs for Veterans and Military Members With Posttraumatic Stress Disorder: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414686. doi: 10.1001/jamanetworkopen.2024.14686.
PubMed 38833250Leighton SC, Rodriguez KE, Zhuang R, Jensen CL, Miller EA, Sabbaghi A, O'Haire ME. Psychiatric service dog placements are associated with better daily psychosocial functioning for military veterans with posttraumatic stress disorder. Psychol Trauma. 2024 Dec;16(Suppl 3):S707-S717. doi: 10.1037/tra0001543. Epub 2023 Jul 6.
PubMed 37410417
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03245814
- Acronym / sponsor ID
- 1R21HD091896-01
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- service dogs, human-animal interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 23 Oct 2024
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 quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).
Detailed description
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Service Dog | Experimental | Behavioral: Service DogParticipants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog. |
| Waitlist Control | No intervention | –Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Service DogA service dog trained to perform tasks that are specific to PTSD | Behavioural | Service Dog |
Primary outcome
PTSD Severity and Symptoms Via Self-report
Time frame: 3 months
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.
PTSD Severity and Symptoms Via Clinician Rating
Time frame: 3 months
Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome.
Depression
Time frame: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Anxiety
Time frame: 3 months
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
9 secondary outcomes
Social Isolation
Time frame: 3 months
Companionship
Time frame: 3 months
Ability to Participate in Social Activities
Time frame: 3 months
Mental Health Quality of Life
Time frame: 3 months
Psychological Well-being
Time frame: 3 months
Life Satisfaction
Time frame: 3 months
Resilience
Time frame: 3 months
Anger
Time frame: 3 months
Daily Socio-emotional Experiences
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40580066Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Baus JJ, Ashbeck EL, Brown EA, Mehl MR, Taylor DJ, van Marle K, Schwichtenberg AJ, Bedrick EJ, O'Haire ME. Sleep-wake dynamics in veteran-service dog dyads: an exploration of overnight concordance. Sleep. 2025 Nov 10;48(11):zsaf177. doi: 10.1093/sleep/zsaf177.
- Derived from this study: PubMed 38833250Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Davis LW, Ashbeck EL, Bedrick EJ, O'Haire ME. Service Dogs for Veterans and Military Members With Posttraumatic Stress Disorder: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414686. doi: 10.1001/jamanetworkopen.2024.14686.
- Derived from this study: PubMed 37410417Leighton SC, Rodriguez KE, Zhuang R, Jensen CL, Miller EA, Sabbaghi A, O'Haire ME. Psychiatric service dog placements are associated with better daily psychosocial functioning for military veterans with posttraumatic stress disorder. Psychol Trauma. 2024 Dec;16(Suppl 3):S707-S717. doi: 10.1037/tra0001543. Epub 2023 Jul 6.
- Individual participant dataSharing planned: No
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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.
Marguerite O'Haire, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service Dog in people with Post Traumatic Stress Disorder, run by University of Arizona 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?
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 23 Oct 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). 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?
PTSD Severity and Symptoms Via Self-report (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245814, which also lists 3 linked publications.
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 23 Oct 2024.