<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/NCT04500457</url>
  </required_header>
  <id_info>
    <org_study_id>HSC2019.27351</org_study_id>
    <nct_id>NCT04500457</nct_id>
  </id_info>
  <brief_title>Exposure-Based Treatment for Perfectionism</brief_title>
  <official_title>A Preliminary Evaluation of an Exposure-Based Treatment for Perfectionism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is examining the efficacy of a computerized, exposure-based, intervention for&#xD;
      perfectionism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to evaluate the effects of a two-week computerized&#xD;
      exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism&#xD;
      will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of&#xD;
      three tasks in which they will repeatedly make mistakes, repeated for five sessions over a&#xD;
      two-week period (one session every 3 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2019</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale</measure>
    <time_frame>Levels of perfectionism from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale (CES-D)</measure>
    <time_frame>Depression symptoms from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)</measure>
    <time_frame>Anxiety symptoms from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Phobia Inventory (SPIN)</measure>
    <time_frame>Social anxiety symptoms from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Attitudes Test (EAT-26)</measure>
    <time_frame>Eating disorder symptoms from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive-Compulsive Inventory- Revised (OCI-R)</measure>
    <time_frame>Obsessive-compulsiveness from baseline to post treatment (2 weeks)</time_frame>
    <description>Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Perfectionism</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this condition will not receive treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure-based Treatment for Perfectionism (ETP)</intervention_name>
    <description>Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Score of at least 29 on the Frost Multidimensional Perfectionism Scale- Concern over&#xD;
             Mistakes subscale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current moderate or severe substance use disorder, psychotic disorder, or bipolar&#xD;
             disorder&#xD;
&#xD;
          -  Current suicidal ideation (imminent risk)&#xD;
&#xD;
          -  Currently participating in psychotherapy&#xD;
&#xD;
          -  Any changes to psychotropic medications in the past four weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida State University, Department of Psychology</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <results_first_submitted>August 30, 2022</results_first_submitted>
  <results_first_submitted_qc>July 25, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2023</results_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Jesse Cougle</investigator_full_name>
    <investigator_title>Associate Professor of Psychology</investigator_title>
  </responsible_party>
  <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>October 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT04500457/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
        </group>
        <group group_id="P2">
          <title>Wait-List Control</title>
          <description>Participants in this condition will not receive treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
        </group>
        <group group_id="B2">
          <title>Wait-List Control</title>
          <description>Participants in this condition will not receive treatment.</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="39"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="76"/>
          </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="20.10" spread="6.09"/>
                    <measurement group_id="B2" value="18.89" spread="1.31"/>
                    <measurement group_id="B3" value="19.91" spread="4.47"/>
                  </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="37"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="39"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale</title>
        <description>Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale score.</description>
        <time_frame>Levels of perfectionism from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale</title>
          <description>Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale 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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.54" spread="4.10"/>
                    <measurement group_id="O2" value="35.76" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.97" spread="6.39"/>
                    <measurement group_id="O2" value="35.71" spread="4.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Center for Epidemiological Studies Depression Scale (CES-D)</title>
        <description>Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.</description>
        <time_frame>Depression symptoms from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Center for Epidemiological Studies Depression Scale (CES-D)</title>
          <description>Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.</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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.26" spread="8.33"/>
                    <measurement group_id="O2" value="22.97" spread="12.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.69" spread="8.12"/>
                    <measurement group_id="O2" value="23.77" spread="11.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)</title>
        <description>Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.</description>
        <time_frame>Anxiety symptoms from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)</title>
          <description>Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.</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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.33" spread="9.75"/>
                    <measurement group_id="O2" value="43.95" spread="12.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.19" spread="11.07"/>
                    <measurement group_id="O2" value="43.95" spread="11.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Phobia Inventory (SPIN)</title>
        <description>Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.</description>
        <time_frame>Social anxiety symptoms from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Social Phobia Inventory (SPIN)</title>
          <description>Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.</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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.15" spread="13.08"/>
                    <measurement group_id="O2" value="30.08" spread="17.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.58" spread="12.79"/>
                    <measurement group_id="O2" value="32.31" spread="16.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eating Attitudes Test (EAT-26)</title>
        <description>Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.</description>
        <time_frame>Eating disorder symptoms from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Eating Attitudes Test (EAT-26)</title>
          <description>Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.</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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.82" spread="9.09"/>
                    <measurement group_id="O2" value="12.03" spread="9.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.05" spread="9.46"/>
                    <measurement group_id="O2" value="14.34" spread="11.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Obsessive-Compulsive Inventory- Revised (OCI-R)</title>
        <description>Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.</description>
        <time_frame>Obsessive-compulsiveness from baseline to post treatment (2 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
          </group>
          <group group_id="O2">
            <title>Wait-List Control</title>
            <description>Participants in this condition will not receive treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Obsessive-Compulsive Inventory- Revised (OCI-R)</title>
          <description>Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.</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="36"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.89" spread="13.18"/>
                    <measurement group_id="O2" value="26.68" spread="13.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.34" spread="13.95"/>
                    <measurement group_id="O2" value="25.54" spread="13.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).&#xD;
Exposure-based Treatment for Perfectionism (ETP): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.</description>
        </group>
        <group group_id="E2">
          <title>Wait-List Control</title>
          <description>Participants in this condition will not receive treatment.</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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </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>Jesse Cougle</name_or_title>
      <organization>Florida State University</organization>
      <phone>8506458729</phone>
      <email>cougle@psy.fsu.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/NCT04500457
org study id: HSC2019.27351
nct id: NCT04500457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is examining the efficacy of a computerized, exposure-based, intervention for
      perfectionism.
The primary aim of this study is to evaluate the effects of a two-week computerized
      exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism
      will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of
      three tasks in which they will repeatedly make mistakes, repeated for five sessions over a
      two-week period (one session every 3 days).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale
time frame: Levels of perfectionism from baseline to post treatment (2 weeks)
description: Self-report questionnaire examining levels of perfectionism. The concern over mistakes sub-scale of the Frost Multidimensional Perfectionism Scale includes 9 items with scores on the sub-scale ranging from 9 to 45 (higher scores signify higher levels of concern over mistakes). The concern over mistakes sub-scale includes the following items from the Frost Multidimensional Perfectionism Scale: 9, 10, 13, 14, 18, 21, 23, 25, 24. Item scores are summed for a total sub-scale score.
measure: Center for Epidemiological Studies Depression Scale (CES-D)
time frame: Depression symptoms from baseline to post treatment (2 weeks)
description: Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.
measure: State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
time frame: Anxiety symptoms from baseline to post treatment (2 weeks)
description: Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
measure: Social Phobia Inventory (SPIN)
time frame: Social anxiety symptoms from baseline to post treatment (2 weeks)
description: Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
measure: Eating Attitudes Test (EAT-26)
time frame: Eating disorder symptoms from baseline to post treatment (2 weeks)
description: Self-report scale that measures eating disorder symptoms. Scores range from 0 to 78 with higher scores indicating higher levels of eating disorder symptoms.
measure: Obsessive-Compulsive Inventory- Revised (OCI-R)
time frame: Obsessive-compulsiveness from baseline to post treatment (2 weeks)
description: Self-report scale that measures obsessive-compulsiveness. Scores range from 0 to 72 with higher scores indicating higher levels of obsessive-compulsiveness.
arm group label: Intervention
arm group type: Experimental
description: This arm consists of a 2-week computerized, exposure-based intervention. Treatment sessions are completed every 3 days at home (5 treatment sessions total).
arm group label: Wait-List Control
arm group type: No Intervention
description: Participants in this condition will not receive treatment.
intervention type: Behavioral
intervention name: Exposure-based Treatment for Perfectionism (ETP)
description: Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Jesse Cougle
investigator title: Associate Professor of Psychology
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 