<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/NCT02234622</url>
  </required_header>
  <id_info>
    <org_study_id>D1487-R</org_study_id>
    <nct_id>NCT02234622</nct_id>
  </id_info>
  <brief_title>Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms</brief_title>
  <acronym>RELIEVE</acronym>
  <official_title>Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given the limited effectiveness of current treatments and the burden PTSD places on Veterans,&#xD;
      civilians and clinicians, this research aims to compare the effects of a standardized,&#xD;
      traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and&#xD;
      relaxation practices) with a wellness program (wellness topics and physical activity) on PTSD&#xD;
      symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness&#xD;
      among Veterans. However, current PTSD treatments are not effective for all, and a significant&#xD;
      number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has&#xD;
      been increased interest within the military and VA in Complementary and Alternative Medicine&#xD;
      approaches, such as yoga, to improve symptoms without requiring direct verbal processing of&#xD;
      the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing&#xD;
      numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and&#xD;
      emotional well-being. Because of this unique approach to the biological, psychological, and&#xD;
      social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand&#xD;
      for more effective PTSD treatment options for Veterans. Recent research indicates that yoga&#xD;
      interventions can be delivered successfully to individuals who have PTSD and have the&#xD;
      potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and&#xD;
      anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved&#xD;
      small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there&#xD;
      is much variation among studies in the style and components of yoga interventions. Thus, a&#xD;
      randomized controlled trial of a standardized, traditional, holistic yoga intervention is&#xD;
      urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga&#xD;
      as an adjunct to currently available PTSD treatments.&#xD;
&#xD;
      OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic&#xD;
      Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related&#xD;
      symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the&#xD;
      interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions'&#xD;
      effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety,&#xD;
      pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga&#xD;
      Program and training process for experienced yoga teachers to deliver HYP to individuals who&#xD;
      have PTSD in order to facilitate future study and dissemination efforts.&#xD;
&#xD;
      METHODS: This study sample will include 212 outpatients with a clinician-confirmed diagnosis&#xD;
      of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental&#xD;
      health clinicians and military/Veterans' organizations, who will be randomly assigned to&#xD;
      receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will&#xD;
      involve a standardized 16-week intervention consisting of: 1) in-person group yoga class&#xD;
      taught by a yoga therapist (Yoga Alliance minimum 200 hour level) with trained&#xD;
      assistants.Classes will include (1) yoga postures, breathing practices, deep muscle&#xD;
      contraction practices, relaxation practices, and integration of scientific rational and yoga&#xD;
      philosophy within the instruction; (2) video and audio recordings for home practice; and 4) a&#xD;
      Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an&#xD;
      attention control comprised of low intensity walking and didactics about wellness topics that&#xD;
      will also encourage home practice and provide a Participant Handbook to reinforce concepts&#xD;
      taught during in-person sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2015</start_date>
  <completion_date type="Actual">August 9, 2018</completion_date>
  <primary_completion_date type="Actual">August 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinician Administered PTSD Scale (CAPS-5)</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSD Checklist</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory-II</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spielberger State-Trait Anxiety (STAI) - State Subscale</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Item #3</measure>
    <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
    <description>Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <arm_group>
    <arm_group_label>Holistic Yoga Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness Lifestyle Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Holistic Yoga Program</intervention_name>
    <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
    <arm_group_label>Holistic Yoga Program</arm_group_label>
    <other_name>HYP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Lifestyle Program</intervention_name>
    <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.</description>
    <arm_group_label>Wellness Lifestyle Program</arm_group_label>
    <other_name>WLP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Veterans and civilians will be eligible for inclusion if&#xD;
&#xD;
          -  they are age 18 or older,&#xD;
&#xD;
          -  have a Clinician Administered PTSD Scale-confirmed PTSD diagnosis,&#xD;
&#xD;
          -  and access to a working telephone for ease of contact during the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria will include:&#xD;
&#xD;
          -  severe medical conditions in which yoga is contraindicated;&#xD;
&#xD;
          -  active psychosis;&#xD;
&#xD;
          -  active suicidal intent;&#xD;
&#xD;
          -  moderate to severe cognitive impairment as determined by the short Mini-Mental State&#xD;
             Examination, a six-item screener (MMSE);&#xD;
&#xD;
          -  involvement in ongoing yoga classes and/or regular home practice of yoga in the&#xD;
             previous 3 months;&#xD;
&#xD;
          -  and receiving ongoing medical or psychological treatment that includes more than one&#xD;
             hour weekly of relaxation and mind-body based stress reduction strategies (related&#xD;
             directly to meditation and yoga).&#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>Louanne W Davis, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richard L. Roudebush VA Medical Center, Indianapolis, IN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Richard L. Roudebush VA Medical Center, Indianapolis, IN</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-2884</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>July 29, 2019</results_first_submitted>
  <results_first_submitted_qc>March 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Disorders, Post-Traumatic</keyword>
  <keyword>Yoga</keyword>
  <keyword>Veterans</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02234622/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Holistic Yoga Program</title>
          <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
        </group>
        <group group_id="P2">
          <title>Wellness Lifestyle Program</title>
          <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
      <group_list>
        <group group_id="B1">
          <title>Holistic Yoga Program</title>
          <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
        </group>
        <group group_id="B2">
          <title>Wellness Lifestyle Program</title>
          <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</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="108"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="209"/>
          </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="49.9" spread="12.6"/>
                    <measurement group_id="B2" value="51.2" spread="13.3"/>
                    <measurement group_id="B3" value="50.6" spread="12.9"/>
                  </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="38"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinician Administered PTSD Scale 5</title>
          <description>Scores range 0-80 with higher scores meaning a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.1" spread="8.7"/>
                    <measurement group_id="B2" value="36.0" spread="8.7"/>
                    <measurement group_id="B3" value="36.57" spread="8.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PTSD Checklist 5</title>
          <description>Scores range 0-80 with higher scores indicating worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.2" spread="12.1"/>
                    <measurement group_id="B2" value="45.1" spread="13.0"/>
                    <measurement group_id="B3" value="45.14" spread="12.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinician Administered PTSD Scale (CAPS-5)</title>
        <description>The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Administered PTSD Scale (CAPS-5)</title>
          <description>The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8" spread="12.1"/>
                    <measurement group_id="O2" value="31.0" spread="13.0"/>
                  </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>0.002</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.6</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.2</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PTSD Checklist</title>
        <description>PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Checklist</title>
          <description>PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="17.5"/>
                    <measurement group_id="O2" value="40.2" spread="15.2"/>
                  </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>0.005</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-6.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.3</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II</title>
        <description>Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when a retrospective audit of the Clinician Administered PTSD Scale revealed they did not meet diagnostic criteria for PTSD</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II</title>
          <description>Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.</description>
          <population>three participants were removed from the analysis when a retrospective audit of the Clinician Administered PTSD Scale revealed they did not meet diagnostic criteria for PTSD</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="21.2"/>
                    <measurement group_id="O2" value="55" spread="20.7"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.6</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.9</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a</title>
        <description>PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a</title>
          <description>PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="8.9"/>
                    <measurement group_id="O2" value="58.9" spread="9.2"/>
                  </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>0.482</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory-II</title>
        <description>Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory-II</title>
          <description>Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="12.2"/>
                    <measurement group_id="O2" value="18.7" spread="10.7"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.635</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.7</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spielberger State-Trait Anxiety (STAI) - State Subscale</title>
        <description>Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Spielberger State-Trait Anxiety (STAI) - State Subscale</title>
          <description>Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" spread="11"/>
                    <measurement group_id="O2" value="27.6" spread="11.6"/>
                  </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>0.367</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Item #3</title>
        <description>Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.</description>
        <time_frame>Change from baseline to 16 weeks (end of treatment)</time_frame>
        <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Holistic Yoga Program</title>
            <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
          </group>
          <group group_id="O2">
            <title>Wellness Lifestyle Program</title>
            <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Item #3</title>
          <description>Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.</description>
          <population>three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.7"/>
                    <measurement group_id="O2" value="4.9" 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>0.668</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>1.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Holistic Yoga Program</title>
          <description>The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.&#xD;
Holistic Yoga Program: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.</description>
        </group>
        <group group_id="E2">
          <title>Wellness Lifestyle Program</title>
          <description>The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity with didactics about wellness topics.&#xD;
Wellness Lifestyle Program: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity physical activity (walking) with didactics about wellness topics.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>All participants were from one large city in the Midwest. The yoga intervention was designed to address PTSD by a yoga therapist who trained the yoga teacher assistants and may not apply to all types of yoga classes.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Louanne Davis Psy.D.</name_or_title>
      <organization>Roudebush VA Medical Center</organization>
      <phone>317-710-1338</phone>
      <email>louannedavis52@gmail.com</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/NCT02234622
org study id: D1487-R
nct id: NCT02234622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Given the limited effectiveness of current treatments and the burden PTSD places on Veterans,
      civilians and clinicians, this research aims to compare the effects of a standardized,
      traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and
      relaxation practices) with a wellness program (wellness topics and physical activity) on PTSD
      symptoms.
Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness
      among Veterans. However, current PTSD treatments are not effective for all, and a significant
      number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has
      been increased interest within the military and VA in Complementary and Alternative Medicine
      approaches, such as yoga, to improve symptoms without requiring direct verbal processing of
      the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing
      numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and
      emotional well-being. Because of this unique approach to the biological, psychological, and
      social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand
      for more effective PTSD treatment options for Veterans. Recent research indicates that yoga
      interventions can be delivered successfully to individuals who have PTSD and have the
      potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and
      anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved
      small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there
      is much variation among studies in the style and components of yoga interventions. Thus, a
      randomized controlled trial of a standardized, traditional, holistic yoga intervention is
      urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga
      as an adjunct to currently available PTSD treatments.

      OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic
      Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related
      symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the
      interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions'
      effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety,
      pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga
      Program and training process for experienced yoga teachers to deliver HYP to individuals who
      have PTSD in order to facilitate future study and dissemination efforts.

      METHODS: This study sample will include 212 outpatients with a clinician-confirmed diagnosis
      of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental
      health clinicians and military/Veterans' organizations, who will be randomly assigned to
      receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will
      involve a standardized 16-week intervention consisting of: 1) in-person group yoga class
      taught by a yoga therapist (Yoga Alliance minimum 200 hour level) with trained
      assistants.Classes will include (1) yoga postures, breathing practices, deep muscle
      contraction practices, relaxation practices, and integration of scientific rational and yoga
      philosophy within the instruction; (2) video and audio recordings for home practice; and 4) a
      Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an
      attention control comprised of low intensity walking and didactics about wellness topics that
      will also encourage home practice and provide a Participant Handbook to reinforce concepts
      taught during in-person sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinician Administered PTSD Scale (CAPS-5)
time frame: Change from baseline to 16 weeks (end of treatment)
description: The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.
measure: PTSD Checklist
time frame: Change from baseline to 16 weeks (end of treatment)
description: PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.
measure: Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II
time frame: Change from baseline to 16 weeks (end of treatment)
description: Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.
measure: Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a
time frame: Change from baseline to 16 weeks (end of treatment)
description: PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100
measure: Beck Depression Inventory-II
time frame: Change from baseline to 16 weeks (end of treatment)
description: Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.
measure: Spielberger State-Trait Anxiety (STAI) - State Subscale
time frame: Change from baseline to 16 weeks (end of treatment)
description: Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.
measure: Brief Pain Inventory (BPI) Item #3
time frame: Change from baseline to 16 weeks (end of treatment)
description: Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.
arm group label: Holistic Yoga Program
arm group type: Experimental
description: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
arm group label: Wellness Lifestyle Program
arm group type: Active Comparator
description: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.
intervention type: Behavioral
intervention name: Holistic Yoga Program
description: The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
arm group label: Holistic Yoga Program
other name: HYP
intervention type: Behavioral
intervention name: Wellness Lifestyle Program
description: The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.
arm group label: Wellness Lifestyle Program
other name: WLP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Louanne W Davis, PsyD
role: Principal Investigator
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All participants were from one large city in the Midwest. The yoga intervention was designed to address PTSD by a yoga therapist who trained the yoga teacher assistants and may not apply to all types of yoga classes.
point of contact: 