<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/NCT03790878</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00089935</org_study_id>
    <secondary_id>1F31MH117830-01A1</secondary_id>
    <nct_id>NCT03790878</nct_id>
  </id_info>
  <brief_title>Emotion Regulation and Emotion Perception</brief_title>
  <acronym>EREP</acronym>
  <official_title>Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mind and Life Institute, Hadley, Massachusetts</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of a brief, emotion regulation intervention&#xD;
      on the ability to perceive other people's emotions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Decision to close enrollment was made on January 2, 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment</measure>
    <time_frame>During the laboratory experiment (week 1)</time_frame>
    <description>Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment</measure>
    <time_frame>After the one week of phone-based intervention</time_frame>
    <description>Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)</measure>
    <time_frame>Beginning of Week one laboratory experiment, End of Week one laboratory experiment</time_frame>
    <description>SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)</measure>
    <time_frame>Laboratory assessment, up to one week</time_frame>
    <description>Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Emotions</condition>
  <arm_group>
    <arm_group_label>Mindful Breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Habituation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Breathing</intervention_name>
    <description>Training in a mindful breathing skill that reduces emotional distress</description>
    <arm_group_label>Mindful Breathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Habituation</intervention_name>
    <description>An exposure procedure that reduces emotional distress through habituation</description>
    <arm_group_label>Habituation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>No emotion regulation intervention, placebo</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages 18-55;&#xD;
&#xD;
          2. have a smartphone and agree to receive text-messages;&#xD;
&#xD;
          3. have difficulty with their relationships or social interactions;&#xD;
&#xD;
          4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation&#xD;
             Scale (DERS)(Gratz &amp; Roemer, 2004) with scores over 90.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current mania;&#xD;
&#xD;
          2. Meets full criteria for any current psychotic disorder;&#xD;
&#xD;
          3. Currently/chronically homeless;&#xD;
&#xD;
          4. Current suicidal ideation;&#xD;
&#xD;
          5. Psychiatric hospitalization within past 6 months;&#xD;
&#xD;
          6. Unable to read, blind or deaf. Our previous study recruited only participants who were&#xD;
             currently in treatment, but this study will include both participants who are&#xD;
             currently in treatment, as well as those who are not in treatment.&#xD;
&#xD;
          7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient&#xD;
             (Auyeung &amp; Baron-Cohen, 2012).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Z Rosenthal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <results_first_submitted>December 17, 2020</results_first_submitted>
  <results_first_submitted_qc>February 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 24, 2021</results_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emotion Dysregulation</keyword>
  <keyword>Empathy</keyword>
  <keyword>Emotion Perception</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.</ipd_description>
  </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>July 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03790878/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>11 participants were considered screen failures</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mindful Breathing</title>
          <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
        </group>
        <group group_id="P2">
          <title>Habituation</title>
          <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
        </group>
        <group group_id="P3">
          <title>Control</title>
          <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mindful Breathing</title>
          <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
        </group>
        <group group_id="B2">
          <title>Habituation</title>
          <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
        </group>
        <group group_id="B3">
          <title>Control</title>
          <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</description>
        </group>
        <group group_id="B4">
          <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="26"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="27"/>
            <count group_id="B4" value="80"/>
          </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="27.56" spread="7.56"/>
                    <measurement group_id="B2" value="23.77" spread="7.03"/>
                    <measurement group_id="B3" value="23.77" spread="20"/>
                    <measurement group_id="B4" value="25" spread="6.77"/>
                  </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="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="16"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="70"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="25"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment</title>
        <description>Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.</description>
        <time_frame>During the laboratory experiment (week 1)</time_frame>
        <population>Baseline data for one participant was not completed appropriately and was omitted from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindful Breathing</title>
            <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
          </group>
          <group group_id="O2">
            <title>Habituation</title>
            <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</description>
          </group>
        </group_list>
        <measure>
          <title>The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment</title>
          <description>Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.</description>
          <population>Baseline data for one participant was not completed appropriately and was omitted from the analysis.</population>
          <units>Percent of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.31" spread="14.36"/>
                    <measurement group_id="O2" value="81.93" spread="17.94"/>
                    <measurement group_id="O3" value="84.85" spread="16"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.018</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment</title>
        <description>Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.</description>
        <time_frame>After the one week of phone-based intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindful Breathing</title>
            <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
          </group>
          <group group_id="O2">
            <title>Habituation</title>
            <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment</title>
          <description>Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.</description>
          <units>units 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="26"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.19" spread="2.57"/>
                    <measurement group_id="O2" value="5.3" spread="2.54"/>
                    <measurement group_id="O3" value="5.23" spread="2.59"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.396</p_value>
            <method>Multilevel modeling</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)</title>
        <description>SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score.</description>
        <time_frame>Beginning of Week one laboratory experiment, End of Week one laboratory experiment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindful Breathing</title>
            <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
          </group>
          <group group_id="O2">
            <title>Habituation</title>
            <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)</title>
          <description>SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score.</description>
          <units>units 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="26"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="1.21"/>
                    <measurement group_id="O2" value="0.61" spread="0.9"/>
                    <measurement group_id="O3" value="0.56" spread="0.95"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Multilevel modeling</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)</title>
        <description>Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal.</description>
        <time_frame>Laboratory assessment, up to one week</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 weeks. Adverse events were assessed at intake, training session, and exit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mindful Breathing</title>
          <description>Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.&#xD;
Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress</description>
        </group>
        <group group_id="E2">
          <title>Habituation</title>
          <description>Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.&#xD;
Habituation: An exposure procedure that reduces emotional distress through habituation</description>
        </group>
        <group group_id="E3">
          <title>Control</title>
          <description>Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.&#xD;
Control: No emotion regulation intervention, placebo</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
              </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>Katherine (Kibby) McMahon</name_or_title>
      <organization>Duke University</organization>
      <phone>917-880-1551</phone>
      <email>Kibby.McMahon@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03790878
org study id: Pro00089935
secondary id: 1F31MH117830-01A1
nct id: NCT03790878
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the impact of a brief, emotion regulation intervention
      on the ability to perceive other people's emotions.
Decision to close enrollment was made on January 2, 2020.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment
time frame: During the laboratory experiment (week 1)
description: Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy.
measure: Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment
time frame: After the one week of phone-based intervention
description: Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence.
measure: Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)
time frame: Beginning of Week one laboratory experiment, End of Week one laboratory experiment
description: SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score.
measure: Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)
time frame: Laboratory assessment, up to one week
description: Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal.
arm group label: Mindful Breathing
arm group type: Experimental
description: Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.
arm group label: Habituation
arm group type: Active Comparator
description: Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.
arm group label: Control
arm group type: Placebo Comparator
description: Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.
intervention type: Behavioral
intervention name: Mindful Breathing
description: Training in a mindful breathing skill that reduces emotional distress
arm group label: Mindful Breathing
intervention type: Behavioral
intervention name: Habituation
description: An exposure procedure that reduces emotional distress through habituation
arm group label: Habituation
intervention type: Behavioral
intervention name: Control
description: No emotion regulation intervention, placebo
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Z Rosenthal, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 