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Service Dog Training Program for Military Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT03777020
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Erika Friedmann, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Service Dog Training Program Other: Dog Training Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Service Dog Training Program
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 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.
Other: Dog Training Education
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Stress biomarker markers:cortisol [ Time Frame: 8 weeks ]
    salivary cortisol ug/dL; higher is more stress

  2. Stress biomarkers: alpha amylase [ Time Frame: 8 weeks ]
    salivary alpha amylase U/mL; higher is more stress

  3. Stress biomarkers: IgA [ Time Frame: 8 weeks ]
    salivary immunoglobulin A μg/mL; higher is less stress

  4. 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

  5. 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

  6. 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

  7. 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. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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


Other Outcome Measures:
  1. Cellular Aging [ Time Frame: 8 weeks ]
    total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Accepted into the Warrior Canine Connection Service Dog Training Program. Their inclusion criteria are:

    1. military veteran;
    2. diagnosis of PTSD;
    3. able to give informed consent; and
    4. able to understand English; And
  2. Served in military on or after 9/11/2001.

Exclusion Criteria:

Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria are:

  1. fear of dogs;
  2. allergy to pet dander;
  3. active substance abuse;
  4. active psychosis, or
  5. history of animal abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777020


Contacts
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Contact: Deb Taber, BA 410-706-4233 dtaber@umaryland.edu
Contact: Erika Friedmann, PhD 4107060659 friedmann@umaryland.edu

Locations
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United States, Maryland
Warrior Canine Connections Recruiting
Boyds, Maryland, United States, 20841
Contact: Erika Friedmann, PhD    410-706-0659    friedmann@umaryland.edu   
Contact: Cheryl Krause-Parello, RN, PhD       ckrausep@health.fau.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Erika Friedmann, PhD University of Maryland School of Nursing

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Responsible Party: Erika Friedmann, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03777020     History of Changes
Other Study ID Numbers: HP-00083872
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erika Friedmann, University of Maryland, Baltimore:
human-animal interaction
service dog
stress
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders