<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777020</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00083872</org_study_id>
    <nct_id>NCT03777020</nct_id>
  </id_info>
  <brief_title>Service Dog Training Program for Military Veterans With PTSD</brief_title>
  <official_title>Evaluating the Efficacy of a Service Dog Training Program for Military Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1&#xD;
      of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial&#xD;
      functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and&#xD;
      psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and&#xD;
      function within family and society. Alarming veteran PTSD rates and its insidious effects&#xD;
      demand empirically validated treatment programs. More than a million veterans receive new&#xD;
      diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of&#xD;
      veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training&#xD;
      a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise&#xD;
      in other populations. This project evaluates the efficacy of a service dog training program&#xD;
      (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with&#xD;
      PTSD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Veterans with PTSD attend 8 weekly sessions of either training a service dog or learning&#xD;
      about how to train a dog at the Warrior Canine Connection facility in Boyds MD. They complete&#xD;
      questionnaires prior to the start of the program and at the midpoint (after 4 sessions) and&#xD;
      end of the program (after 8 sessions). Participants also wear a monitor to record heart rate&#xD;
      variability during the 1st, 4th, and 8th sessions and provide saliva samples at these same&#xD;
      times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2019</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post traumatic stress symptom severity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress biomarker markers:cortisol</measure>
    <time_frame>8 weeks</time_frame>
    <description>salivary cortisol ug/dL; higher is more stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress biomarkers: alpha amylase</measure>
    <time_frame>8 weeks</time_frame>
    <description>salivary alpha amylase U/mL; higher is more stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress biomarkers: IgA</measure>
    <time_frame>8 weeks</time_frame>
    <description>salivary immunoglobulin A μg/mL; higher is less stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress biomarkers: HRV</measure>
    <time_frame>8 weeks</time_frame>
    <description>Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress marker: Perceived Stress</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Positive Affect</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Health Related Quality of Life</measure>
    <time_frame>8 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Resilience</measure>
    <time_frame>8 weeks</time_frame>
    <description>Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Relationship with Friends and Family</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Quality of Individual's Relationships</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Satisfaction with Social Activities</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Companionship</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health:Depression</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Anxiety</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Health: Suicidal Ideation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cellular Aging</measure>
    <time_frame>8 weeks</time_frame>
    <description>total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Service Dog Training Program (SDTP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dog Training Education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Service Dog Training Program</intervention_name>
    <description>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.</description>
    <arm_group_label>Service Dog Training Program (SDTP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dog Training Education</intervention_name>
    <description>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.</description>
    <arm_group_label>Dog Training Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Accepted into the Warrior Canine Connection Service Dog Training Program. Their&#xD;
             inclusion criteria are:&#xD;
&#xD;
               1. military veteran;&#xD;
&#xD;
               2. diagnosis of PTSD;&#xD;
&#xD;
               3. able to give informed consent; and&#xD;
&#xD;
               4. able to understand English; And&#xD;
&#xD;
          2. Military Veteran&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Excluded from the Warrior Canine Connection Service Dog Training Program. Their criteria&#xD;
        are:&#xD;
&#xD;
          1. fear of dogs;&#xD;
&#xD;
          2. allergy to pet dander;&#xD;
&#xD;
          3. active substance abuse;&#xD;
&#xD;
          4. active psychosis, or&#xD;
&#xD;
          5. history of animal abuse&#xD;
&#xD;
          6. Excluded by the WCC from participation in their Service Dog Training Program because&#xD;
             they have:&#xD;
&#xD;
        fear of dogs; allergy to pet dander; active substance abuse; active psychosis, history of&#xD;
        animal abuse or physically unable to complete tasks required to train dogs&#xD;
&#xD;
        .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erika Friedmann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Warrior Canine Connections</name>
      <address>
        <city>Boyds</city>
        <state>Maryland</state>
        <zip>20841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Erika Friedmann</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>human-animal interaction</keyword>
  <keyword>service dog</keyword>
  <keyword>stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 30, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777020
org study id: HP-00083872
nct id: NCT03777020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post traumatic stress symptom severity
time frame: 8 weeks
description: Post traumatic stress disorder checklist for DSM-5 range of scores 0-80; higher score is worse (more PTSD)
measure: Stress biomarker markers:cortisol
time frame: 8 weeks
description: salivary cortisol ug/dL; higher is more stress
measure: Stress biomarkers: alpha amylase
time frame: 8 weeks
description: salivary alpha amylase U/mL; higher is more stress
measure: Stress biomarkers: IgA
time frame: 8 weeks
description: salivary immunoglobulin A μg/mL; higher is less stress
measure: Stress biomarkers: HRV
time frame: 8 weeks
description: Heart rate variability Polar H7 heart rate sensor worn around the chest and matching Polar V800 GPS Sports Watch, higher is better
measure: Stress marker: Perceived Stress
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Positive Affect
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Health Related Quality of Life
time frame: 8 weeks
description: 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).
measure: Psychosocial Health: Resilience
time frame: 8 weeks
description: Connor-Davidson Resilience Scale (CD-RISC-10), scores range from 0 to 40, higher score is more resilient
measure: Psychosocial Health: Relationship with Friends and Family
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Quality of Individual's Relationships
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Satisfaction with Social Activities
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Companionship
time frame: 8 weeks
description: 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
measure: Psychosocial Health:Depression
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Anxiety
time frame: 8 weeks
description: 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
measure: Psychosocial Health: Suicidal Ideation
time frame: 8 weeks
description: Beck Scale for Suicide Ideation (BSSI), raw scores range from 0 to 38, higher score is greater suicidal ideation
measure: Cellular Aging
time frame: 8 weeks
description: total telomere length (kilobase pairs, from saliva sample) longer telomere length is less cellular aging
arm group label: Service Dog Training Program (SDTP)
arm group type: Experimental
description: 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.
arm group label: Dog Training Education
arm group type: Other
description: 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 type: Behavioral
intervention name: Service Dog Training Program
description: 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.
arm group label: Service Dog Training Program (SDTP)
intervention type: Other
intervention name: Dog Training Education
description: 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.
arm group label: Dog Training Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erika Friedmann, PhD
role: Principal Investigator
affiliation: University of Maryland, School of Nursing
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Erika Friedmann
investigator title: Professor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
submitted: May 30, 2023