<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/NCT01729026</url>
  </required_header>
  <id_info>
    <org_study_id>D0809-P</org_study_id>
    <nct_id>NCT01729026</nct_id>
  </id_info>
  <brief_title>A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder (PTSD)</brief_title>
  <acronym>VITAL</acronym>
  <official_title>A Study of Dog Adoption in Veterans With Posttraumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide preliminary data on the feasibility and impact of&#xD;
      adopting a dog from an animal shelter as a supplement to usual care in Veterans with&#xD;
      Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic Stress Disorder, a common mental disorder among Veterans, is marked by painful&#xD;
      re-experiencing of a traumatic event, often together with depression, fearfulness, and social&#xD;
      isolation. Despite major advances in rehabilitation, many Veterans continue to be disabled by&#xD;
      PTSD. One possible new approach involves the use of shelter dogs, which might relieve&#xD;
      symptoms and aid reintegration into society by providing emotional support and a greater&#xD;
      sense of security. In this randomized controlled trial of 48 Veterans with chronic PTSD, we&#xD;
      will evaluate whether the half who adopt a dog from the San Antonio Humane Society show&#xD;
      greater improvement in their PTSD symptoms over the first three months than the half who are&#xD;
      assigned to a waiting list.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Early Phase 1</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up</measure>
    <time_frame>Baseline and 3-month follow-up visit.</time_frame>
    <description>The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory - II (BDI-II) Score</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Community Integration Questionnaire (CIQ) Total Score</measure>
    <time_frame>Baseline and 3-month follow-up visit</time_frame>
    <description>Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-9 (PHQ-9) Score</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Improvement in Quality of Life After Dog Adoption</measure>
    <time_frame>Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls</time_frame>
    <description>Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scores on the UCLA Loneliness Scale, Version 3</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)</measure>
    <time_frame>Baseline and 3-month Follow-up</time_frame>
    <description>The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)</measure>
    <time_frame>Baseline and 3-month follow-up</time_frame>
    <description>The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Posttraumatic Stress Disorder (PTSD)</condition>
  <arm_group>
    <arm_group_label>Shelter Dog Adoption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list, Then Adoption after 3 Months</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shelter Dog Adoption</intervention_name>
    <description>Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
    <arm_group_label>Shelter Dog Adoption</arm_group_label>
    <arm_group_label>Wait-list, Then Adoption after 3 Months</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition (DSM-5)&#xD;
             criteria for current PTSD as determined by the Clinician-Administered PTSD Scale for&#xD;
             DSM-5 (CAPS)&#xD;
&#xD;
          -  Scores 39 or greater on the PTSD Checklist for DSM-5 (PCL-5)&#xD;
&#xD;
          -  Feels able to afford to care for a dog after the anticipated annual costs of&#xD;
             approximately $750 are outlined&#xD;
&#xD;
          -  If married or cohabiting, spouse or significant other agrees with the decision to&#xD;
             adopt a dog&#xD;
&#xD;
          -  If not a homeowner, landlady or landlord agrees to allow the dog to reside on the&#xD;
             property&#xD;
&#xD;
          -  Agrees to keep the dog inside most of the time&#xD;
&#xD;
          -  Agrees to be the primary caretaker for the dog&#xD;
&#xD;
          -  Had a dog previously as a child or adult&#xD;
&#xD;
          -  Served during the Vietnam era or more recently&#xD;
&#xD;
          -  In active therapy for at least 1 month, with plans to remain in active therapy&#xD;
&#xD;
          -  Has been in a stable housing situation for the last 3 months&#xD;
&#xD;
          -  Case manager for any Veteran who is in the Housing and Urban Development/VA Subsidized&#xD;
             Housing (HUD/VASH) program has been consulted prior to study enrollment&#xD;
&#xD;
          -  Has a plan for someone else to take care of the dog if she or he can't&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had a dog or other companion animal within the past 12 months&#xD;
&#xD;
          -  Has current alcohol or drug abuse or dependence&#xD;
&#xD;
          -  Has a primary psychiatric diagnosis other than PTSD&#xD;
&#xD;
          -  Has had significant suicide/homicide risk in the past 3 months&#xD;
&#xD;
          -  Has had psychosis or mania in the past 3 months&#xD;
&#xD;
          -  Has had a psychiatric admission during the past 3 months&#xD;
&#xD;
          -  Has mental or physical impairments that would interfere with caring for the dog or&#xD;
             self&#xD;
&#xD;
          -  Has a history of moderate to severe traumatic brain injury (TBI) (subjects with&#xD;
             moderate TBI will be allowed to participate in the study if a Physical Medicine and&#xD;
             Rehabilitation physician determines it is acceptable)&#xD;
&#xD;
          -  Requires a puppy&#xD;
&#xD;
          -  Requires a breed that is uncommonly available for adoption at the San Antonio Humane&#xD;
             Society&#xD;
&#xD;
          -  Requires a pit bull or other fierce dog&#xD;
&#xD;
          -  Veteran's mental health clinician or Physical Medicine and Rehabilitation physician&#xD;
             reports a past history of animal cruelty or abuse or expresses concern about the&#xD;
             potential for such behavior&#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>Stephen L. Stern, MD BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>South Texas Health Care System, San Antonio, TX</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Texas Health Care System, San Antonio, TX</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>February 23, 2016</results_first_submitted>
  <results_first_submitted_qc>April 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 27, 2016</results_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Veterans</keyword>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>dog adoption</keyword>
  <keyword>companion animal</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment opened in October 2013 and closed at the end of September 2014. Subjects learned about the study primarily from clinical staff or from posters and brochures that were distributed throughout the clinics of the South Texas Veterans Health Care System in San Antonio.</recruitment_details>
      <pre_assignment_details>Two of the 22 consented subjects were not randomized: one left before he was evaluated and the second did not meet entry criteria. A third subject was randomized to the Adoption group but subsequently found not to meet criteria for PTSD, leaving 9 in this group and 10 in the Wait-List group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Shelter Dog Adoption</title>
          <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
        <group group_id="P2">
          <title>Wait-list, Then Adoption After 3 Months</title>
          <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization to 3-month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3-month to 6-month (Final) Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Shelter Dog Adoption</title>
          <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
        <group group_id="B2">
          <title>Wait-list, Then Adoption After 3 Months</title>
          <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.0" spread="13.8"/>
                    <measurement group_id="B2" value="39.2" spread="11.4"/>
                    <measurement group_id="B3" value="42.1" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up</title>
        <description>The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).</description>
        <time_frame>Baseline and 3-month follow-up visit.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up</title>
          <description>The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.20" spread="3.52"/>
                    <measurement group_id="O2" value="-7.77" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.141</p_value>
            <p_value_desc>Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.</p_value_desc>
            <method>Mixed effects regression models</method>
            <param_type>Effect size (Cohen's d)</param_type>
            <param_value>-0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.85</ci_lower_limit>
            <ci_upper_limit>0.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)</title>
        <description>The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)</title>
          <description>The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="3.0"/>
                    <measurement group_id="O2" value="1.5" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.982</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>-0.0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score</title>
        <description>Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score</title>
          <description>Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.6"/>
                    <measurement group_id="O2" value="0.7" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.160</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>-0.5</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Beck Depression Inventory - II (BDI-II) Score</title>
        <description>The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Beck Depression Inventory - II (BDI-II) Score</title>
          <description>The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.41" spread="1.72"/>
                    <measurement group_id="O2" value="-0.19" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.015</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>-1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.49</ci_lower_limit>
            <ci_upper_limit>-0.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Community Integration Questionnaire (CIQ) Total Score</title>
        <description>Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.</description>
        <time_frame>Baseline and 3-month follow-up visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Community Integration Questionnaire (CIQ) Total Score</title>
          <description>Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.1"/>
                    <measurement group_id="O2" value="2.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.59</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>0.2</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Health Questionnaire-9 (PHQ-9) Score</title>
        <description>The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Health Questionnaire-9 (PHQ-9) Score</title>
          <description>The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.07" spread="1.20"/>
                    <measurement group_id="O2" value="0.71" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>mixed effects regression models</param_type>
            <param_value>-1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.50</ci_lower_limit>
            <ci_upper_limit>-0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)</title>
        <description>The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)</title>
          <description>The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.</description>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)</title>
        <description>Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)</title>
          <description>Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="1.4"/>
                    <measurement group_id="O2" value="1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.188</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>0.9</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Improvement in Quality of Life After Dog Adoption</title>
        <description>Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog</description>
        <time_frame>Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls</time_frame>
        <population>Participants who had a dog for 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improvement in Quality of Life After Dog Adoption</title>
          <description>Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog</description>
          <population>Participants who had a dog for 3 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Scores on the UCLA Loneliness Scale, Version 3</title>
        <description>The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Scores on the UCLA Loneliness Scale, Version 3</title>
          <description>The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="3.5"/>
                    <measurement group_id="O2" value="3.4" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031</p_value>
            <method>mixed effects regression models</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>1.2</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)</title>
        <description>The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).</description>
        <time_frame>Baseline and 3-month Follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)</title>
          <description>The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.01" spread="4.34"/>
                    <measurement group_id="O2" value="2.30" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.541</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)</title>
        <description>The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)</description>
        <time_frame>Baseline and 3-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shelter Dog Adoption</title>
            <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a San Antonio Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog.&#xD;
Following adoption, Veterans and their dogs will receive 8 weeks of free obedience training provided by a veterinarian,</description>
          </group>
          <group group_id="O2">
            <title>Wait-list, Then Adoption After 3 Months</title>
            <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a San Antonio Humane Society adoption counselor and study staff and take it home to live with them The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive 8 weeks of free obedience training by a veterinarian.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)</title>
          <description>The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.7"/>
                    <measurement group_id="O2" value="-1.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Please note that a minus number indicates an increase in pain ratings.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.139</p_value>
            <method>effect size (Cohen's d)</method>
            <param_type>effect size (Cohen's d)</param_type>
            <param_value>0.6</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Shelter Dog Adoption</title>
          <description>Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
        <group group_id="E2">
          <title>Wait-list, Then Adoption After 3 Months</title>
          <description>After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.&#xD;
Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Emotional distress - reasons given under Additional Description</sub_title>
                <description>wished dog had more room to run, worried dog was at home alone, unhappy was assigned to wait-list, dog chewed up things, dog dug up yard, dog too energetic, dog smelled bad, dog growled (2), dog had medical problems (2)</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Stephen Stern</name_or_title>
      <organization>South Texas Veterans Health Care System; University of Texas Health Science Center at San Antonio</organization>
      <phone>210-887-3754</phone>
      <email>stephen.stern@va.gov; sterns@uthscsa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01729026
org study id: D0809-P
nct id: NCT01729026
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to provide preliminary data on the feasibility and impact of
      adopting a dog from an animal shelter as a supplement to usual care in Veterans with
      Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.
Posttraumatic Stress Disorder, a common mental disorder among Veterans, is marked by painful
      re-experiencing of a traumatic event, often together with depression, fearfulness, and social
      isolation. Despite major advances in rehabilitation, many Veterans continue to be disabled by
      PTSD. One possible new approach involves the use of shelter dogs, which might relieve
      symptoms and aid reintegration into society by providing emotional support and a greater
      sense of security. In this randomized controlled trial of 48 Veterans with chronic PTSD, we
      will evaluate whether the half who adopt a dog from the San Antonio Humane Society show
      greater improvement in their PTSD symptoms over the first three months than the half who are
      assigned to a waiting list.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up
time frame: Baseline and 3-month follow-up visit.
description: The PCL-5 is a self-rating scale based on the DSM-5 diagnostic criteria for Posttraumatic Stress Disorder. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
measure: Change in Total Score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS)
time frame: Baseline and 3-month follow-up
description: The Clinician-Administered PTSD Scale for DSM-5 (CAPS) is a semi-structured interview that assesses the severity of current symptoms for Posttraumatic Stress Disorder (PTSD). The total score ranges from 0 (no symptoms) to 80 (maximal symptoms).
measure: Change in Alcohol Use Disorders Identification Test (AUDIT-C) Total Score
time frame: Baseline and 3-month follow-up
description: Self-rating scale that assesses the frequency and extent of hazardous drinking. The range of the scale is from 0 (no hazardous drinking) to 12 (extremely hazardous drinking).
measure: Change in Beck Depression Inventory - II (BDI-II) Score
time frame: Baseline and 3-month follow-up
description: The Beck Depression Inventory - II is a self rating scale that assesses the severity of depressive symptoms. The range of the scale is from 0 (no symptoms) to 63 (maximal symptoms).
measure: Change in Community Integration Questionnaire (CIQ) Total Score
time frame: Baseline and 3-month follow-up visit
description: Self-rating scale that assesses the extent of a subject's integration into her or his community. The range of the scale is from 0 (minimal integration) to 29 (maximal integration). A positive change indicates an improvement in integration.
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
time frame: Baseline and 3-month follow-up
description: The Patient Health Questionnaire-9 (PHQ-9) is a self-rating scale that assesses the severity of the symptoms of a major depressive episode. Scores range from 0 (no symptoms) to 27 (maximal symptoms).
measure: Percent of Subjects Reporting More Frequent Physical Activity Sessions on the Physical Activity Questionnaire (PAQ)
time frame: Baseline and 3-month follow-up
description: The PAQ is a self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months. The percent reporting increased frequency of physical activity sessions can range from 0 to 100.
measure: Change in the Global Score on the Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)
time frame: Baseline and 3-month follow-up
description: Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD. Scores range from 0 (excellent sleep quality) to 42 (very poor sleep quality).
measure: Number of Participants With Improvement in Quality of Life After Dog Adoption
time frame: Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls
description: Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog
measure: Change in Scores on the UCLA Loneliness Scale, Version 3
time frame: Baseline and 3-month follow-up
description: The UCLA Loneliness Scale, Version 3 is a self-rating scale that measures the severity of symptoms of loneliness. The range of the scale if from 20 (no symptoms) to 80 (maximal symptoms).
measure: Changes in the Mental Component Score of the Veterans RAND 12-item Health Survey (VR-12)
time frame: Baseline and 3-month Follow-up
description: The VR-12 is a12-item self-rating scale that assess health-related quality of life. The results are expressed as two scores, a Mental Component Score and a Physical Component Score. The Mental Component Score measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health), while the Physical Component Score measures physical aspects of quality of life and also ranges from 0 (extremely poor physical health) to 100 (extremely good physical health).
measure: Changes in Current Pain Ratings on the Numeric Rating Scale for Pain Intensity (NPS)
time frame: Baseline and 3-month follow-up
description: The NPS asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain)
arm group label: Shelter Dog Adoption
arm group type: Experimental
description: Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
arm group label: Wait-list, Then Adoption after 3 Months
arm group type: Active Comparator
description: After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
intervention type: Other
intervention name: Shelter Dog Adoption
description: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
arm group label: Shelter Dog Adoption
arm group label: Wait-list, Then Adoption after 3 Months
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen L. Stern, MD BA
role: Principal Investigator
affiliation: South Texas Health Care System, San Antonio, TX
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 