Post Traumatic Stress DisorderNCT03777020
Service Dog Training Program for Military Veterans With PTSD
A study testing Service Dog Training Program and Dog Training Education in people with Post Traumatic Stress Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Service Dog Training Program and Dog Training Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 28 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:
- military veteran;
- diagnosis of PTSD;
- able to give informed consent; and
- able to understand English; And
- Military Veteran
Who cannot join
- Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:
- fear of dogs;
- allergy to pet dander;
- active substance abuse;
- active psychosis, or
- history of animal abuse
Show all 9Show fewer
- Excluded by the WCC from participation in their Service Dog Training Program because they have:
- fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of animal abuse or physically unable to complete tasks required to train dogs
- .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD
Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.
Read the detailed description
Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Service Dog Training Program, Dog Training Education
- Keywords
- human-animal interaction, service dog, stress
- 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 Dog Training ProgramBehavioural
Participate in 8 weekly dog training sessions using a positive reinforcement method and curriculum under the direct supervision of trainer at the Warrior Canine Connection facility in Boyds (Montgomery County) MD.
Dog Training EducationOther
Learn about training dogs by watching 8 weekly dog training online modules programs at the Warrior Canine Connection facility in Boyds (Montgomery County) MD. After completing this education the participants will participate in the service dog training program.
| Study group | Role | What they receive |
|---|---|---|
| Service Dog Training Program (SDTP) | Experimental | Veterans randomized to the SDTP will be paired with an experienced Warrior Canine Connection (WCC) Mission Based Trauma Recovery (MBTR)-Trainer (MBRT-T) and a service dog (SD). One hour training modules will be scheduled once a week for 8 weeks. Participants will come to WCC for all the weekly training modules. Participants will be paired with the same SD for the duration of the SDTP unless an unforeseen circumstance arises and the SD needs to be removed from the SDTP. The MBTR-T will deliver the prescribed SDTP modules created by WCC. Each session will be fully supervised by a WCC MBTR-T to address any concerns or safety issues that may arise. Receives: Behavioral: Service Dog Training Program |
| Dog Training Education | Other | Veterans randomized to Dog Training Education will participate in one hour online SD training modules (https://e-trainingfordogs.com) scheduled once a week for 8 weeks. The online training modules are delivered by experienced SD trainers and will employ parallel content to the WCC SDTP. Participants will come to the WCC site for all the weekly online training modules. Members of the WLCI group will have education about dog training, but NO interaction with a SD. The online training modules for the DTE group are intended to keep the veterans who are not immediately assigned to the SDTP engaged in the study. They will participate in the SDTP after conclusion of participation in the 8 week study. Receives: Other: Dog Training Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress Symptom Severity
Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)
Measured: Baseline, 8 weeks
Secondary outcomes (15)
Stress Biomarker Markers:Cortisol
salivary cortisol ug/dL; higher is more stress
Measured: Baseline, 8 weeks
Stress Biomarkers: Alpha Amylase
salivary alpha amylase U/mL; higher is more stress
Measured: Baseline, 8 weeks
Stress Biomarkers: IgA
salivary immunoglobulin A μg/mL; higher is less stress
Measured: Baseline, 8 weeks
Stress Biomarkers: HRV
Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better
Measured: baseline, 8 weeks
Stress Marker: Perceived Stress
Patient Reported Outcomes Measurement Information System (PROMIS) Perceived Stress; PROMIS PS, score range 10 to 50, T scores range from 22.7 to 87.1, higher is more stress perceived
Measured: Baseline, 8 weeks
Psychosocial Health: Positive Affect
PROMIS Positive Affect Short Form 15 (PA 152), raw scores range from 15 to 75 they are converted to T scores range of 14.4 to 69.9 with a mean of 50 and SD or 10, higher is greater positive affect
Measured: Baseline, 8 weeks
Psychosocial Health: Health Related Quality of Life
Veterans RAND 12 Item Health Survey (VR-12); physical health and mental health subscales; scales are calculated with an algorithm with a mean of 50 as the 50th percentile of the U.S. population; higher score is better (higher quality of life).
Measured: Baseline, 8 weeks
Psychosocial Health: Resilience
Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
Measured: Baseline, 8 weeks
Psychosocial Health: Relationship With Friends and Family
Relationship Scale Questionnaire (RSQ) , 4 subscales are created from average of items: Secure scale is the average of 3, 9(Reverse),10, 15, 28(Reverse). Fearful scale is the average of 1, 5, 12, 24. Preoccupied scale is the average of 6(Reverse), 8, 16, 25. Dismissing scale is the average of 2, 6, 19, 22, 26. Subscale scores range from 1 to 5. Higher scores are poorer relationships
Measured: Baseline, 8 weeks
Psychosocial Health: Quality of Individual's Relationships
PROMIS Satisfaction with Social Roles and Activities (SSRA)-Short Form 4a (PROMIS-SSRA), raw scores range from 4 to 20, T scores range from 27.9 to 63.8, higher score is more satisfaction
Measured: Baseline, 8 weeks
Psychosocial Health: Satisfaction With Social Activities
PROMIS Short Form v1.0- Satisfaction with Participation in Discretionary Social Activities- Short Form 7a (PROMIS SPDSA) raw scores range from 7 to 35, T scores range from 28.7 to 67.3, higher score is more satisfaction
Measured: Baseline, 8 weeks
Psychosocial Health: Companionship
PROMIS Companionship - Short Form 4a (PROMIS-C) raw scores range from 4 to 20, T scores range from 25.2 to 65.3, higher score is more companionship
Measured: Baseline, 8 weeks
Psychosocial Health:Depression
PROMIS Depression Short-Form 8a (PROMIS-D), raw scores range from 8 to 40, T scores range from 0-100, higher score is more depression
Measured: baseline, 8 weeks
Psychosocial Health: Anxiety
PROMIS Anxiety Short-Form 8a (PROMIS-A) raw scores range from 8 to 40, T scores range from 0-100, higher score is more anxiety
Measured: baseline, 8 weeks
Psychosocial Health: Suicidal Ideation
Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start22 Aug 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Friedmann, University of Maryland, Baltimore
- Investigators
- Erika Friedmann, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777020
- Sponsor's protocol ID
- HP-00083872
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2018
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03777020
- Acronym / sponsor ID
- HP-00083872
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- human-animal interaction, service dog, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.
Detailed description
Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and end of the program (after 8 sessions). Participants also wear a monitor to record heart rate variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Service Dog Training Program (SDTP) | Experimental | Behavioral: Service Dog Training ProgramVeterans randomized to the SDTP will be paired with an experienced Warrior Canine Connection (WCC) Mission Based Trauma Recovery (MBTR)-Trainer (MBRT-T) and a service dog (SD). One hour training modules will be scheduled once a week for 8 weeks. Participants will come to WCC for all the weekly training modules. Participants will be paired with the same SD for the duration of the SDTP unless an unforeseen circumstance arises and the SD needs to be removed from the SDTP. The MBTR-T will deliver the prescribed SDTP modules created by WCC. Each session will be fully supervised by a WCC MBTR-T to address any concerns or safety issues that may arise. |
| Dog Training Education | Other | Other: Dog Training EducationVeterans randomized to Dog Training Education will participate in one hour online SD training modules (https://e-trainingfordogs.com) scheduled once a week for 8 weeks. The online training modules are delivered by experienced SD trainers and will employ parallel content to the WCC SDTP. Participants will come to the WCC site for all the weekly online training modules. Members of the WLCI group will have education about dog training, but NO interaction with a SD. The online training modules for the DTE group are intended to keep the veterans who are not immediately assigned to the SDTP engaged in the study. They will participate in the SDTP after conclusion of participation in the 8 week study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:
- Military Veteran
Key exclusion criteria (9 listed)
- Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:
- fear of dogs;
- allergy to pet dander;
- active substance abuse;
- active psychosis, or
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 Dog Training ProgramParticipate in 8 weekly dog training sessions using a positive reinforcement method and curriculum under the direct supervision of trainer at the Warrior Canine Connection facility in Boyds (Montgomery County) MD. | Behavioural | Service Dog Training Program (SDTP) |
| Dog Training EducationLearn about training dogs by watching 8 weekly dog training online modules programs at the Warrior Canine Connection facility in Boyds (Montgomery County) MD. After completing this education the participants will participate in the service dog training program. | Other | Dog Training Education |
Primary outcome
Post Traumatic Stress Symptom Severity
Time frame: Baseline, 8 weeks
Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)
15 secondary outcomes
Stress Biomarker Markers:Cortisol
Time frame: Baseline, 8 weeks
Stress Biomarkers: Alpha Amylase
Time frame: Baseline, 8 weeks
Stress Biomarkers: IgA
Time frame: Baseline, 8 weeks
Stress Biomarkers: HRV
Time frame: baseline, 8 weeks
Stress Marker: Perceived Stress
Time frame: Baseline, 8 weeks
Psychosocial Health: Positive Affect
Time frame: Baseline, 8 weeks
Psychosocial Health: Health Related Quality of Life
Time frame: Baseline, 8 weeks
Psychosocial Health: Resilience
Time frame: Baseline, 8 weeks
Psychosocial Health: Relationship With Friends and Family
Time frame: Baseline, 8 weeks
Psychosocial Health: Quality of Individual's Relationships
Time frame: Baseline, 8 weeks
Psychosocial Health: Satisfaction With Social Activities
Time frame: Baseline, 8 weeks
Psychosocial Health: Companionship
Time frame: Baseline, 8 weeks
Psychosocial Health:Depression
Time frame: baseline, 8 weeks
Psychosocial Health: Anxiety
Time frame: baseline, 8 weeks
Psychosocial Health: Suicidal Ideation
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Erika Friedmann, PhD principal investigator
University of Maryland, Baltimore
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 Training Program and Dog Training Education in people with Post Traumatic Stress Disorder, run by University of Maryland, Baltimore 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 6 inclusion and 9 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 26 Jul 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 26 Jul 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?
Post Traumatic Stress Symptom Severity (time frame: Baseline, 8 weeks). 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 26 Jul 2024.