<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/NCT03831360</url>
  </required_header>
  <id_info>
    <org_study_id>1801001977</org_study_id>
    <secondary_id>R34AT009886</secondary_id>
    <nct_id>NCT03831360</nct_id>
  </id_info>
  <brief_title>Treatments for Improving Mood in Depressed Teens-3</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>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Butler Hospital</agency>
      <agency_class>Other</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 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT)&#xD;
      for adolescents with depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of&#xD;
      12 weeks of hatha yoga vs. 12 weeks of group CBT.&#xD;
&#xD;
      Participants will be adolescents with depression. Parents will also be invited to participate&#xD;
      in assessments regarding their child.&#xD;
&#xD;
      Study B, which will run concurrent to Phase 3, will be for participants who did not meet the&#xD;
      depression inclusion criteria or had recent changes in therapy or medications that make them&#xD;
      ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group&#xD;
      participation.&#xD;
&#xD;
      Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT.&#xD;
      Parents will also be invited to participate in assessments regarding their child.&#xD;
&#xD;
      * Due to social distancing requirements related to COVID-19, all interventions have been&#xD;
      delivered remotely via video-based platforms as of late March 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2019</start_date>
  <completion_date type="Actual">September 29, 2021</completion_date>
  <primary_completion_date type="Actual">September 29, 2021</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>Acceptability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.</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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 and the mean of those scores are analyzed, 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>Baseline to post intervention (month 3)</time_frame>
    <description>Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. 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>2</number_of_arms>
  <enrollment type="Actual">30</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 hatha yoga</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of group CBT</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Hatha yoga for depressed adolescents</description>
    <arm_group_label>Hatha Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group CBT</intervention_name>
    <description>Group cognitive behavioral therapy for depressed adolescents</description>
    <arm_group_label>Group CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical,&#xD;
        with the exception that, for Phase 3/ Study B, we will not require elevated depressive&#xD;
        symptoms (a) or stable treatment (b).&#xD;
&#xD;
          1. Adolescents must have elevated depressive symptoms, defined by a score of 10 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;
             8 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;
        Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.&#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 may not meet criteria for the following:&#xD;
&#xD;
               -  Autism spectrum disorder &quot;cannot be ruled out&quot;, and symptoms are of sufficient&#xD;
                  severity to interfere with study treatment per clinician judgement&#xD;
&#xD;
               -  Current psychotic disorder&#xD;
&#xD;
               -  Lifetime history of a manic episode&#xD;
&#xD;
               -  Anorexia or Bulimia in past 3 months&#xD;
&#xD;
               -  Substance use disorders in 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 suicide ideation so severe it will interfere with study&#xD;
             participation.&#xD;
&#xD;
          4. Adolescents cannot currently be engaged in 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>May 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>March 29, 2022</results_first_submitted>
  <results_first_submitted_qc>May 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2022</results_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 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>IPD will be made available to other researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>upon study completion</ipd_time_frame>
    <ipd_access_criteria>PIs will review requests for IPD.</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/60/NCT03831360/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>December 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03831360/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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
        </group>
        <group group_id="P2">
          <title>Group CBT</title>
          <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Hatha Yoga</title>
          <description>12 weeks of hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
        </group>
        <group group_id="B2">
          <title>Group CBT</title>
          <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </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="15.00" spread="1.41"/>
                    <measurement group_id="B2" value="15.00" spread="1.46"/>
                    <measurement group_id="B3" value="15.00" spread="1.40"/>
                  </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="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" 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="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acceptability</title>
        <description>Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.</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="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread=".18"/>
                    <measurement group_id="O2" value="0.71" spread=".17"/>
                  </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 and the mean of those scores are analyzed, 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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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 and the mean of those scores are analyzed, 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="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread=".20"/>
                    <measurement group_id="O2" value="0.55" spread=".24"/>
                  </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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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 group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="4.18"/>
                    <measurement group_id="O2" value="26.1" spread="5.00"/>
                  </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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </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 hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </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>Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.</description>
        <time_frame>Baseline to post intervention (month 3)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hatha Yoga</title>
            <description>12 weeks of hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
          </group>
          <group group_id="O2">
            <title>Group CBT</title>
            <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</description>
          </group>
        </group_list>
        <measure>
          <title>Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)</title>
          <description>Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. 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="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="5.20"/>
                    <measurement group_id="O2" value="8.23" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Three months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hatha Yoga</title>
          <description>12 weeks of hatha yoga&#xD;
Yoga: Hatha yoga for depressed adolescents</description>
        </group>
        <group group_id="E2">
          <title>Group CBT</title>
          <description>12 weeks of group CBT&#xD;
Group CBT: Group cognitive behavioral therapy for depressed adolescents</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>flu</sub_title>
                <description>flu or mild COVID related symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Lisa Uebelacker</name_or_title>
      <organization>Butler Hospital</organization>
      <phone>401-455-6381</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/NCT03831360
org study id: 1801001977
secondary id: R34AT009886
nct id: NCT03831360
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT)
      for adolescents with depression.
In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of
      12 weeks of hatha yoga vs. 12 weeks of group CBT.

      Participants will be adolescents with depression. Parents will also be invited to participate
      in assessments regarding their child.

      Study B, which will run concurrent to Phase 3, will be for participants who did not meet the
      depression inclusion criteria or had recent changes in therapy or medications that make them
      ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group
      participation.

      Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT.
      Parents will also be invited to participate in assessments regarding their child.

      * Due to social distancing requirements related to COVID-19, all interventions have been
      delivered remotely via video-based platforms as of late March 2020.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Acceptability
time frame: 12 weeks
description: Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
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 each scored on a range of 0-1, and the mean of thise is used in analyses. 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 and the mean of those scores are analyzed, 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: Baseline to post intervention (month 3)
description: Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. 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 hatha yoga
arm group label: Group CBT
arm group type: Experimental
description: 12 weeks of group CBT
intervention type: Behavioral
intervention name: Yoga
description: Hatha yoga for depressed adolescents
arm group label: Hatha Yoga
intervention type: Behavioral
intervention name: Group CBT
description: Group cognitive behavioral therapy for depressed adolescents
arm group label: Group CBT
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: IPD will be made available to other researchers upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: upon study completion
ipd access criteria: PIs will review requests for IPD.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 