<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/NCT03799211</url>
  </required_header>
  <id_info>
    <org_study_id>16-00937</org_study_id>
    <nct_id>NCT03799211</nct_id>
  </id_info>
  <brief_title>Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine</brief_title>
  <official_title>Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent&#xD;
      migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is&#xD;
      a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can&#xD;
      be implemented in the headache center setting to help improve initiation and adherence to&#xD;
      behavioral therapy for migraine. We will also assess patients' reasons for making/not making&#xD;
      the appointment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Who Made an Appointment for Behavioral Therapy</measure>
    <time_frame>3-6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Attended Appointments</measure>
    <time_frame>3-6 Months</time_frame>
    <description>Of those who initiated behavioral therapy, percentage who attended appointments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Initiated Appointments</measure>
    <time_frame>Month 3-4 post-recruitment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Reported Importance of Managing Migraine</measure>
    <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
    <description>Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Reported Confidence in Managing Migraines</measure>
    <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
    <description>Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Reported Confidence in Behavioral Therapy</measure>
    <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
    <description>Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing</intervention_name>
    <description>Phone call using motivational interviewing technique</description>
    <arm_group_label>Motivational Interviewing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>will receive a regular study phone call after three months</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Migraine diagnosis age 16+&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read the questionnaire, no phone number&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mia Minen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>June 26, 2020</results_first_submitted>
  <results_first_submitted_qc>July 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2020</results_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</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>Migraine Disorders</mesh_term>
  </condition_browse>
  <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 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03799211/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Motivational Interviewing</title>
          <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Treatment as Usual: will receive a regular study phone call after three months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Motivational Interviewing</title>
          <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Treatment as Usual: will receive a regular study phone call after three months</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="36"/>
            <count group_id="B2" value="40"/>
            <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="40.4" spread="12.3"/>
                    <measurement group_id="B2" value="38.1" spread="12.1"/>
                    <measurement group_id="B3" value="39.3" spread="12.2"/>
                  </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="32"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <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="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="66"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_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="36"/>
                    <measurement group_id="B2" value="40"/>
                    <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>Percentage of Patients Who Made an Appointment for Behavioral Therapy</title>
        <time_frame>3-6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Made an Appointment for Behavioral Therapy</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Attended Appointments</title>
        <description>Of those who initiated behavioral therapy, percentage who attended appointments</description>
        <time_frame>3-6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
          <group group_id="O2">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Attended Appointments</title>
          <description>Of those who initiated behavioral therapy, percentage who attended appointments</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                    <measurement group_id="O2" value="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Initiated Appointments</title>
        <time_frame>Month 3-4 post-recruitment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
          <group group_id="O2">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Initiated Appointments</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Reported Importance of Managing Migraine</title>
        <description>Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.</description>
        <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
          <group group_id="O2">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reported Importance of Managing Migraine</title>
          <description>Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.</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="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only one follow-up call was conducted for this arm</measurement>
                    <measurement group_id="O2" value="9.16" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.19" spread="1.3"/>
                    <measurement group_id="O2" value="9.22" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Reported Confidence in Managing Migraines</title>
        <description>Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.</description>
        <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
          <group group_id="O2">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reported Confidence in Managing Migraines</title>
          <description>Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.</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="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only one follow-up call was conducted for this arm</measurement>
                    <measurement group_id="O2" value="6.26" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.59" spread="2.26"/>
                    <measurement group_id="O2" value="6.62" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Reported Confidence in Behavioral Therapy</title>
        <description>Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.</description>
        <time_frame>First Follow-up Call (1 month post baseline) conducted only for the Arm/Group &quot;Motivational Interviewing&quot; and Last Follow-up Call (3-4 months post baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Treatment as Usual: will receive a regular study phone call after three months</description>
          </group>
          <group group_id="O2">
            <title>Motivational Interviewing</title>
            <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Reported Confidence in Behavioral Therapy</title>
          <description>Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.</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="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Only one follow-up call was conducted for this arm</measurement>
                    <measurement group_id="O2" value="4.83" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Last Follow-Up Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.35" spread="2.59"/>
                    <measurement group_id="O2" value="5.04" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious and other [non-serious] adverse events were not collected or assessed as part of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Motivational Interviewing</title>
          <description>Motivational Interviewing: Phone call using motivational interviewing technique</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Treatment as Usual: will receive a regular study phone call after three months</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Mia Minen, MD, MPH</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>212-263-7744</phone>
      <email>Mia.Minen@nyulangone.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/NCT03799211
org study id: 16-00937
nct id: NCT03799211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent
      migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is
      a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can
      be implemented in the headache center setting to help improve initiation and adherence to
      behavioral therapy for migraine. We will also assess patients' reasons for making/not making
      the appointment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients Who Made an Appointment for Behavioral Therapy
time frame: 3-6 Months
measure: Percentage of Participants Who Attended Appointments
time frame: 3-6 Months
description: Of those who initiated behavioral therapy, percentage who attended appointments
measure: Percentage of Participants Who Initiated Appointments
time frame: Month 3-4 post-recruitment
measure: Mean Reported Importance of Managing Migraine
time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
description: Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.
measure: Mean Reported Confidence in Managing Migraines
time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
description: Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.
measure: Mean Reported Confidence in Behavioral Therapy
time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
description: Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
arm group label: Motivational Interviewing
arm group type: Experimental
arm group label: Usual Care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Motivational Interviewing
description: Phone call using motivational interviewing technique
arm group label: Motivational Interviewing
intervention type: Behavioral
intervention name: Treatment as Usual
description: will receive a regular study phone call after three months
arm group label: Usual Care
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Mia Minen, MD
role: Principal Investigator
affiliation: NYU Langone
facility: 
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 