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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

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 17, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03777020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • Stress biomarker markers:cortisol [ Time Frame: 8 weeks ]
    salivary cortisol ug/dL; higher is more stress
  • Stress biomarkers: alpha amylase [ Time Frame: 8 weeks ]
    salivary alpha amylase U/mL; higher is more stress
  • Stress biomarkers: IgA [ Time Frame: 8 weeks ]
    salivary immunoglobulin A μg/mL; higher is less stress
  • 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
  • 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
  • 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
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 13, 2018)
Cellular Aging [ Time Frame: 8 weeks ]
total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Service Dog Training Program for Military Veterans With PTSD
Official Title  ICMJE Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Traumatic Stress Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Service Dog Training Program
  • 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.
    Intervention: Other: Dog Training Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deb Taber, BA 410-706-4233 dtaber@umaryland.edu
Contact: Erika Friedmann, PhD 4107060659 friedmann@umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03777020
Other Study ID Numbers  ICMJE HP-00083872
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erika Friedmann, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erika Friedmann, PhD University of Maryland School of Nursing
PRS Account University of Maryland, Baltimore
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP