<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/NCT03245814</url>
  </required_header>
  <id_info>
    <org_study_id>1R21HD091896-01</org_study_id>
    <secondary_id>R21HD091896-01</secondary_id>
    <nct_id>NCT03245814</nct_id>
  </id_info>
  <brief_title>Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD</brief_title>
  <official_title>Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marguerite O'Haire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to quantify the therapeutic efficacy and role of trained service&#xD;
      dogs on socio-emotional functioning among military veterans with posttraumatic stress&#xD;
      disorder (PTSD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-term research goal is to evaluate the safety and efficacy of service dogs as a&#xD;
      complementary intervention to enhance biopsychosocial functioning in special populations. The&#xD;
      objective is to conduct a methodologically rigorous trial to quantify the therapeutic&#xD;
      efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on&#xD;
      preliminary findings and qualitative reports, the central hypothesis is that military&#xD;
      veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms&#xD;
      related to socio-emotional functioning and arousal modulation. The rationale for this&#xD;
      research is that its successful completion will provide an evidence-based demonstration of&#xD;
      the efficacy and role of an increasingly used yet poorly tested complementary intervention.&#xD;
      The completion of this project is expected to established an initial demonstration of the&#xD;
      therapeutic efficacy of service dogs in this population, as well as possible mechanisms of&#xD;
      action via specific biological pathways and human-canine interaction profiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 4, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Clinician Administered PTSD Scale for DSM-V (CAPS-5) assessments will be completed via telephone by a trained CAPS-5 rater who will be masked to the intervention and treatment arm of each participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD severity and symptoms via self-report</measure>
    <time_frame>3 months</time_frame>
    <description>Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSD severity and symptoms via clinician rating</measure>
    <time_frame>3 months</time_frame>
    <description>Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social isolation</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Companionship</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to participate in social activities</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological well-being</measure>
    <time_frame>3 months</time_frame>
    <description>Bradburn Scale of Psychological Wellbeing (BSPW)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>Satisfaction with Life Scale (SLS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>3 months</time_frame>
    <description>Connor-Davidson Resilience Scale (CDRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anger</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily socio-emotional experiences</measure>
    <time_frame>3 months</time_frame>
    <description>Ecological momentary assessment (EMA)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Work and activity participation</measure>
    <time_frame>3 months</time_frame>
    <description>Work Productivity and Activity Impairment Questionnaire (WPAIQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Suicidal ideation</measure>
    <time_frame>3 months</time_frame>
    <description>Columbia Suicide Severity Rating Scale (CSSRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep quality</measure>
    <time_frame>3 months</time_frame>
    <description>Pittsburgh Sleep Quality Assessment (PSQI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep disturbance</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep actigraphy</measure>
    <time_frame>3 months</time_frame>
    <description>Actiwatch 2 (Philips Respironics)</description>
  </other_outcome>
  <other_outcome>
    <measure>Salivary cortisol awakening response</measure>
    <time_frame>3 months</time_frame>
    <description>Passive drool method (Salimetrics)</description>
  </other_outcome>
  <other_outcome>
    <measure>Electrodermal activity (skin conductance)</measure>
    <time_frame>3 months</time_frame>
    <description>Embrace wristband (Empatica, Inc.)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Service Dog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Service Dog</intervention_name>
    <description>A service dog trained to perform tasks that are specific to PTSD</description>
    <arm_group_label>Service Dog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for veterans into the study will include:&#xD;
&#xD;
          -  Applied for and approved to receive a dog from K9s For Warriors&#xD;
&#xD;
          -  Military service on or after September 11, 2001&#xD;
&#xD;
          -  Honorable discharge or current honorable service&#xD;
&#xD;
          -  Diagnosis of PTSD&#xD;
&#xD;
          -  No conviction of any crimes against animals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marguerite O'Haire, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Marguerite O'Haire</investigator_full_name>
    <investigator_title>Assistant Professor of Human-Animal Interaction</investigator_title>
  </responsible_party>
  <keyword>service dogs</keyword>
  <keyword>human-animal interaction</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>
  <!-- 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/NCT03245814
org study id: 1R21HD091896-01
secondary id: R21HD091896-01
nct id: NCT03245814
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to quantify the therapeutic efficacy and role of trained service
      dogs on socio-emotional functioning among military veterans with posttraumatic stress
      disorder (PTSD).
The long-term research goal is to evaluate the safety and efficacy of service dogs as a
      complementary intervention to enhance biopsychosocial functioning in special populations. The
      objective is to conduct a methodologically rigorous trial to quantify the therapeutic
      efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on
      preliminary findings and qualitative reports, the central hypothesis is that military
      veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms
      related to socio-emotional functioning and arousal modulation. The rationale for this
      research is that its successful completion will provide an evidence-based demonstration of
      the efficacy and role of an increasingly used yet poorly tested complementary intervention.
      The completion of this project is expected to established an initial demonstration of the
      therapeutic efficacy of service dogs in this population, as well as possible mechanisms of
      action via specific biological pathways and human-canine interaction profiles.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Clinician Administered PTSD Scale for DSM-V (CAPS-5) assessments will be completed via telephone by a trained CAPS-5 rater who will be masked to the intervention and treatment arm of each participant.
measure: PTSD severity and symptoms via self-report
time frame: 3 months
description: Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
measure: PTSD severity and symptoms via clinician rating
time frame: 3 months
description: Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5)
measure: Depression
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a
measure: Anxiety
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a
measure: Social isolation
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a
measure: Companionship
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a
measure: Ability to participate in social activities
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a
measure: Mental health quality of life
time frame: 3 months
description: Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component
measure: Psychological well-being
time frame: 3 months
description: Bradburn Scale of Psychological Wellbeing (BSPW)
measure: Life satisfaction
time frame: 3 months
description: Satisfaction with Life Scale (SLS)
measure: Resilience
time frame: 3 months
description: Connor-Davidson Resilience Scale (CDRS)
measure: Anger
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a
measure: Daily socio-emotional experiences
time frame: 3 months
description: Ecological momentary assessment (EMA)
measure: Work and activity participation
time frame: 3 months
description: Work Productivity and Activity Impairment Questionnaire (WPAIQ)
measure: Suicidal ideation
time frame: 3 months
description: Columbia Suicide Severity Rating Scale (CSSRS)
measure: Sleep quality
time frame: 3 months
description: Pittsburgh Sleep Quality Assessment (PSQI)
measure: Sleep disturbance
time frame: 3 months
description: Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a
measure: Sleep actigraphy
time frame: 3 months
description: Actiwatch 2 (Philips Respironics)
measure: Salivary cortisol awakening response
time frame: 3 months
description: Passive drool method (Salimetrics)
measure: Electrodermal activity (skin conductance)
time frame: 3 months
description: Embrace wristband (Empatica, Inc.)
arm group label: Service Dog
arm group type: Experimental
description: Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.
arm group label: Waitlist Control
arm group type: No Intervention
description: Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.
intervention type: Behavioral
intervention name: Service Dog
description: A service dog trained to perform tasks that are specific to PTSD
arm group label: Service Dog
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marguerite O'Haire, Ph.D.
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Purdue University
investigator full name: Marguerite O'Haire
investigator title: Assistant Professor of Human-Animal Interaction
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No