Service Dog Training Program for Military Veterans With PTSD

NCT03777020 | Completed Results

• 1 other identifier: HP-00083872
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Traumatic Stress Disorder

Keywords

human-animal interaction; service dog; stress

Outcome Measures

Primary Outcomes (1)

• Post Traumatic Stress Symptom Severity

  Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)

  Baseline, 8 weeks

Secondary Outcomes (15)

• Stress Biomarker Markers:Cortisol

  Baseline, 8 weeks

• Stress Biomarkers: Alpha Amylase

  Baseline, 8 weeks

• Stress Biomarkers: IgA

  Baseline, 8 weeks

• Stress Biomarkers: HRV

  baseline, 8 weeks

• Stress Marker: Perceived Stress

  Baseline, 8 weeks

Other Outcomes (1)

• Cellular Aging

  Baseline, 8 weeks

Study Arms (2)

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.

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.

Other: Dog Training Education

Interventions

Service Dog Training Program BEHAVIORAL

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.

Service Dog Training Program (SDTP)

Dog Training Education OTHER

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.

Dog Training Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• military veteran;
• diagnosis of PTSD;
• able to give informed consent; and
• able to understand English; And
• Military Veteran

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Warrior Canine Connections

Boyds, Maryland, 20841, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Erika Friedmann
• Organization: University of Maryland School of Nursing

friedmann@umaryland.edu

410 706 0659

Study Officials

• Erika Friedmann, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: August 22, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)