- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777020
Service Dog Training Program for Military Veterans With PTSD
May 3, 2023 updated by: Erika Friedmann, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deb Taber, BA
- Phone Number: 410-706-4233
- Email: dtaber@umaryland.edu
Study Contact Backup
- Name: Erika Friedmann, PhD
- Phone Number: 4107060659
- Email: friedmann@umaryland.edu
Study Locations
-
-
Maryland
-
Boyds, Maryland, United States, 20841
- Warrior Canine Connections
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
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
Exclusion Criteria:
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
- 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
.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Service Dog Training Program (SDTP)
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.
|
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.
|
Other: Dog Training Education
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post traumatic stress symptom severity
Time Frame: 8 weeks
|
Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress biomarker markers:cortisol
Time Frame: 8 weeks
|
salivary cortisol ug/dL; higher is more stress
|
8 weeks
|
Stress biomarkers: alpha amylase
Time Frame: 8 weeks
|
salivary alpha amylase U/mL; higher is more stress
|
8 weeks
|
Stress biomarkers: IgA
Time Frame: 8 weeks
|
salivary immunoglobulin A μg/mL; higher is less stress
|
8 weeks
|
Stress biomarkers: HRV
Time Frame: 8 weeks
|
Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better
|
8 weeks
|
Stress marker: Perceived Stress
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Positive Affect
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Health Related Quality of Life
Time Frame: 8 weeks
|
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).
|
8 weeks
|
Psychosocial Health: Resilience
Time Frame: 8 weeks
|
Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
|
8 weeks
|
Psychosocial Health: Relationship with Friends and Family
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Quality of Individual's Relationships
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Satisfaction with Social Activities
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Companionship
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health:Depression
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Anxiety
Time Frame: 8 weeks
|
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
|
8 weeks
|
Psychosocial Health: Suicidal Ideation
Time Frame: 8 weeks
|
Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cellular Aging
Time Frame: 8 weeks
|
total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2019
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
December 10, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 17, 2018
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00083872
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Traumatic Stress Disorder
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University of California, Los AngelesRecruitingPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
Clinical Trials on Service Dog Training Program
-
Henry M. Jackson Foundation for the Advancement...Walter Reed National Military Medical Center; Uniformed Services University...UnknownTraumatic Brain Injury | Posttraumatic Stress Disorder | Post-traumatic Stress DisorderUnited States
-
Linkoeping UniversityMinistry of Health and Social Affairs, SwedenCompletedEpilepsy | Diabetes | Impairment
-
University of ArizonaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPost Traumatic Stress DisorderUnited States
-
University of AarhusRecruitingStress, Emotional | Sleep Disorders, Circadian Rhythm | Physiological ResponsesDenmark
-
University of ArizonaEunice Kennedy Shriver National Institute of Child Health and Human Development...Enrolling by invitationStress Disorders, Post-Traumatic | Combat Stress Disorders | Animal-Human BondingUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...Recruiting
-
University of ValenciaCompletedHeart TransplantationSpain
-
Chang Gung Memorial HospitalMinistry of Science and Technology, Taiwan; Chang Gung University of Science...Active, not recruiting
-
Oregon State UniversityRecruitingPhysical Activity | Social WellbeingUnited States
-
University of Massachusetts, AmherstCompleted