<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/NCT03831347</url>
  </required_header>
  <id_info>
    <org_study_id>1801001977 Open</org_study_id>
    <secondary_id>R34AT009886</secondary_id>
    <nct_id>NCT03831347</nct_id>
  </id_info>
  <brief_title>Treatments for Improving Mood in Depressed Teens-2</brief_title>
  <acronym>TeenThrive</acronym>
  <official_title>Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Butler Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test&#xD;
      the adapted hatha yoga intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week&#xD;
      adapted hatha yoga intervention.&#xD;
&#xD;
      the investigators will enroll 12 adolescents in the open pilot trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">August 29, 2019</completion_date>
  <primary_completion_date type="Actual">August 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Post intervention (month 3)</time_frame>
    <description>Acceptability assessed based on number of participants who remained in the intervention (retention).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale</measure>
    <time_frame>Week 1</time_frame>
    <description>Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>Post intervention (month 3)</time_frame>
    <description>Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Home Practice Questionnaire</measure>
    <time_frame>Post intervention (month 3)</time_frame>
    <description>Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)</measure>
    <time_frame>Post intervention (month 3)</time_frame>
    <description>Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)</measure>
    <time_frame>post intervention (month 3)</time_frame>
    <description>Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Hatha Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hatha Yoga</intervention_name>
    <description>12 weeks of Hatha Yoga</description>
    <arm_group_label>Hatha Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adolescents must have elevated depressive symptoms, defined by a score of 11 or higher&#xD;
             on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating&#xD;
             (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.&#xD;
&#xD;
          2. Other treatment for depression must be stable at baseline. Adolescents do not have to&#xD;
             be in other treatment for depression, but, if they are, it must be stable for the past&#xD;
             12 weeks.&#xD;
&#xD;
          3. Adolescents must be aged 13-18.&#xD;
&#xD;
          4. Adolescents must be medically cleared for moderate physical activity by their primary&#xD;
             care physician. This criterion may be met by a current (dated in the past year)&#xD;
             statement from their pediatrician that the adolescent may participate in school or&#xD;
             camp programs including physical education.&#xD;
&#xD;
          5. Adolescents must be able to read and write English sufficient to complete informed&#xD;
             consent and engage in interventions.&#xD;
&#xD;
          6. Adolescents aged 13-17 must assent to be in the study, and their parent or legal&#xD;
             guardian must consent to their participation. Adolescents aged 18 must consent to be&#xD;
             in the study.&#xD;
&#xD;
          7. Able to attend one of the class times.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not&#xD;
             severely depressed.&#xD;
&#xD;
          2. Adolescents who meet criteria for:&#xD;
&#xD;
               -  Current (past year) autism spectrum disorder (AS), if of sufficient severity to&#xD;
                  interfere with study treatment per clinician judgment;&#xD;
&#xD;
               -  Schizophrenia;&#xD;
&#xD;
               -  Bipolar disorder;&#xD;
&#xD;
               -  Clinically significant psychotic symptoms in the past month;&#xD;
&#xD;
               -  Anorexia or Bulimia in past 3 months&#xD;
&#xD;
               -  Substance use disorders in the past 12 months and symptoms are of sufficient&#xD;
                  severity to interfere with study treatment per clinician judgment These will be&#xD;
                  assessed with the Mini-International Neuropsychiatric Interview (MINI).&#xD;
&#xD;
          3. Adolescents may not have current suicide ideation or behavior that warrants immediate&#xD;
             treatment. They may have passive ideation (i.e., thoughts that life is not worth&#xD;
             living), but may not have active suicide ideation, intent, plan, or an attempt within&#xD;
             the previous 6 months.&#xD;
&#xD;
          4. Adolescents cannot currently be engaged in or yoga classes, as this is the study&#xD;
             intervention.&#xD;
&#xD;
          5. Adolescents cannot be pregnant as yoga should be modified for pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Uebelacker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Butler Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shirley Yen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Butler Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>October 26, 2021</results_first_submitted>
  <results_first_submitted_qc>February 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2022</results_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD underlying publication if required by journal.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>One year after study collection.</ipd_time_frame>
    <ipd_access_criteria>Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.</ipd_access_criteria>
  </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>December 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03831347/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03831347/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hatha Yoga</title>
          <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hatha Yoga</title>
          <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="15.8" spread="1.8"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial and Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acceptability</title>
        <description>Acceptability assessed based on number of participants who remained in the intervention (retention).</description>
        <time_frame>Post intervention (month 3)</time_frame>
        <population>Entire sample</population>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>Acceptability assessed based on number of participants who remained in the intervention (retention).</description>
          <population>Entire sample</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale</title>
        <description>Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale</title>
          <description>Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.</description>
          <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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale</title>
        <description>Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale</title>
          <description>Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.</description>
          <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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Client Satisfaction Questionnaire (CSQ-8)</title>
        <description>Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.</description>
        <time_frame>Post intervention (month 3)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>The Client Satisfaction Questionnaire (CSQ-8)</title>
          <description>Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Home Practice Questionnaire</title>
        <description>Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.</description>
        <time_frame>Post intervention (month 3)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Home Practice Questionnaire</title>
          <description>Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)</title>
        <description>Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.</description>
        <time_frame>Post intervention (month 3)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)</title>
          <description>Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.</description>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)</title>
        <description>Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.</description>
        <time_frame>post intervention (month 3)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</description>
          </group>
        </group_list>
        <measure>
          <title>Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)</title>
          <description>Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hatha Yoga</title>
          <description>12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.&#xD;
Hatha Yoga: 12 weeks of Hatha Yoga</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="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </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="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Celiac</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>GI distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Gynecological issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Lisa Uebelacker</name_or_title>
      <organization>Butler Hospital</organization>
      <phone>401-455-6200</phone>
      <email>LUebelacker@butler.org</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/NCT03831347
org study id: 1801001977 Open
secondary id: R34AT009886
nct id: NCT03831347
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test
      the adapted hatha yoga intervention
In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week
      adapted hatha yoga intervention.

      the investigators will enroll 12 adolescents in the open pilot trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability
time frame: Post intervention (month 3)
description: Acceptability assessed based on number of participants who remained in the intervention (retention).
measure: Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
time frame: Week 1
description: Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are scored on a range of 0-1. Higher scores indicate greater credibility.
measure: Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
time frame: Week 1
description: Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 with higher scores indicating greater expectations.
measure: The Client Satisfaction Questionnaire (CSQ-8)
time frame: Post intervention (month 3)
description: Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
measure: Home Practice Questionnaire
time frame: Post intervention (month 3)
description: Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
measure: Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
time frame: Post intervention (month 3)
description: Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
measure: Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
time frame: post intervention (month 3)
description: Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
arm group label: Hatha Yoga
arm group type: Experimental
description: 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.
intervention type: Behavioral
intervention name: Hatha Yoga
description: 12 weeks of Hatha Yoga
arm group label: Hatha Yoga
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lisa Uebelacker, PhD
role: Principal Investigator
affiliation: Butler Hospital
last name: Shirley Yen, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Yes
ipd description: All IPD underlying publication if required by journal.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: One year after study collection.
ipd access criteria: Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 