xml: <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/NCT05979337</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00237000</org_study_id>
      <secondary_id>7K23NS125004-02</secondary_id>
      <nct_id>NCT05979337</nct_id>
    </id_info>
    <brief_title>Brief Interventions in Chronic Migraine</brief_title>
    <official_title>Brief Behavioral Interventions for Adults With Chronic Migraine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        People with chronic migraine headaches face many challenges, including high levels of daily&#xD;
        pain, disturbances to everyday activities and sleep, and problems with mood such as&#xD;
        depression or anxiety. This trial is being completed to study whether changing an&#xD;
        individual's behaviors may have an impact as a treatment for migraine headaches.&#xD;
  &#xD;
        Eligible participants will be randomized to one of the four arms. This study will be&#xD;
        conducted remotely without in-person contact.&#xD;
  &#xD;
        Study Hypothesis:&#xD;
  &#xD;
          -  There is a main effect of attending either the Empowered Relief and Health Education&#xD;
             intervention on reductions in migraine-related disability 1 month after completing&#xD;
             either intervention&#xD;
  &#xD;
          -  There is a main effect of Empowered Relief and Health Education interventions on&#xD;
             reducing pain-related catastrophizing and migraine symptom severity 1 month after&#xD;
             completing either intervention (secondary hypothesis)&#xD;
  &#xD;
          -  The expected reductions in migraine-related disability, pain catastrophizing, and&#xD;
             migraine symptom severity will be maintained at secondary time points (2 months, 3&#xD;
             months, and 6 months after completing either intervention) (secondary hypothesis)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</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>Factorial Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Migraine Disability Assessment Test (MIDAS) Scores</measure>
      <time_frame>Baseline, 1 month</time_frame>
      <description>The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Disability Assessment Test (MIDAS) Scores</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Disability Assessment Test (MIDAS) Scores</measure>
      <time_frame>Baseline, 3 months</time_frame>
      <description>The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Disability Assessment Test (MIDAS) Scores</measure>
      <time_frame>Baseline, 6 months</time_frame>
      <description>The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change Migraine Symptom Severity Scale (MSSS)</measure>
      <time_frame>Baseline, 1 month</time_frame>
      <description>A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change Migraine Symptom Severity Scale (MSSS)</measure>
      <time_frame>Baseline, 2 month</time_frame>
      <description>A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change Migraine Symptom Severity Scale (MSSS)</measure>
      <time_frame>Baseline, 3 month</time_frame>
      <description>A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change Migraine Symptom Severity Scale (MSSS)</measure>
      <time_frame>Baseline, 6 month</time_frame>
      <description>A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Catastrophizing Scale (PCS)</measure>
      <time_frame>Baseline, 1 month</time_frame>
      <description>The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Catastrophizing Scale (PCS)</measure>
      <time_frame>Baseline, 2 month</time_frame>
      <description>The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Catastrophizing Scale (PCS)</measure>
      <time_frame>Baseline, 3 month</time_frame>
      <description>The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Catastrophizing Scale (PCS)</measure>
      <time_frame>Baseline, 6 month</time_frame>
      <description>The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Chronic Migraine</condition>
    <arm_group>
      <arm_group_label>Empowered Relief (ER) class</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Daily Diaries</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health Education (HE) class</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Empowered Relief (ER) class and Health Education (HE) class</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If randomized to both classes, the HE class will occur first with a week break in between to the ER class.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Empowered Relief</intervention_name>
      <description>This is a single-session (2-hour) behavioral intervention utilizing pain psychology principles (cognitive-behavioral therapy for pain, pain neuroscience education).&#xD;
  Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions.&#xD;
  Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes.&#xD;
  In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life.</description>
      <arm_group_label>Empowered Relief (ER) class</arm_group_label>
      <arm_group_label>Empowered Relief (ER) class and Health Education (HE) class</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Education (HE)</intervention_name>
      <description>This is a single-session (2-hour) health education class reviewing principles of medically indicated self-management of migraine headaches (e.g., consistent dietary and hydration habits, exercise, understanding of and adherence to medical treatment regimens).&#xD;
  Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions.&#xD;
  Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes.&#xD;
  In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life.</description>
      <arm_group_label>Empowered Relief (ER) class and Health Education (HE) class</arm_group_label>
      <arm_group_label>Health Education (HE) class</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as Usual</intervention_name>
      <description>Participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life. In addition, participants will complete daily diaries for 28 days.&#xD;
  If participants are interested in attending classes that were not part of this group assignment, participants will be invited to do so after completing the 6-month follow-up questionnaire.</description>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-reported neurologist diagnosis of chronic migraine&#xD;
  &#xD;
            -  Meets diagnostic criteria for chronic migraine according to the Identify Chronic&#xD;
               Migraine (IDCM) self-reported instrument&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone&#xD;
               or computer) in the home&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently receiving cognitive-behavioral therapy for pain or migraine&#xD;
  &#xD;
            -  Open litigation regarding a medical condition, as assessed in preliminary study&#xD;
               screening&#xD;
  &#xD;
            -  Inability to provide informed consent and complete study procedures (e.g., indications&#xD;
               of suspected major cognitive impairment via observations of study staff during&#xD;
               consenting) that would preclude comprehension or participation in study protocols&#xD;
  &#xD;
            -  Failure to complete at least 7 out of 14 pre-intervention daily diaries&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Sturgeon, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anthony Fauser</last_name>
      <phone>734-998-7034</phone>
      <email>fausera@umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anthony Fauser</last_name>
        <phone>734-998-7034</phone>
        <email>fausera@umich.edu</email>
      </contact>
      <investigator>
        <last_name>John Sturgeon, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>John Sturgeon</investigator_full_name>
      <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>Health Education</keyword>
    <keyword>Migraine-related disability</keyword>
    <keyword>Empowered Relief</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Migraine Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified datasets including participant self-report data (baseline, follow-up and daily diary-based assessments) will be maintained and made available to external researchers upon request via the Inter-University Consortium for Political and Social Research (ICPSR) data repository at University of Michigan.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>De-identified datasets will be made available after publication of the primary study results and/or at the conclusion of the National Institute of Neurological Disorders and Stroke (NINDS)-funded grant study period (currently December 2026, barring any no-cost extension. Data will remain available for at least 3 years beyond the end date of the study.</ipd_time_frame>
      <ipd_access_criteria>Data may be shared with other investigators interested in learning more about the nature of behavioral interventions for individuals with chronic migraine. All datasets will be de-identified and shared only after interested researchers contact ICPSR and complete a restricted data use agreement.&#xD;
  The data and associated documentation will be made available to users only under a restricted data-sharing agreement through ICPSR that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI and ICPSR through the University of Michigan.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979337
  org study id: HUM00237000
  secondary id: 7K23NS125004-02
  nct id: NCT05979337
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  People with chronic migraine headaches face many challenges, including high levels of daily
        pain, disturbances to everyday activities and sleep, and problems with mood such as
        depression or anxiety. This trial is being completed to study whether changing an
        individual's behaviors may have an impact as a treatment for migraine headaches.
  
        Eligible participants will be randomized to one of the four arms. This study will be
        conducted remotely without in-person contact.
  
        Study Hypothesis:
  
          -  There is a main effect of attending either the Empowered Relief and Health Education
             intervention on reductions in migraine-related disability 1 month after completing
             either intervention
  
          -  There is a main effect of Empowered Relief and Health Education interventions on
             reducing pain-related catastrophizing and migraine symptom severity 1 month after
             completing either intervention (secondary hypothesis)
  
          -  The expected reductions in migraine-related disability, pain catastrophizing, and
             migraine symptom severity will be maintained at secondary time points (2 months, 3
             months, and 6 months after completing either intervention) (secondary hypothesis)
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Migraine Disability Assessment Test (MIDAS) Scores
  time frame: Baseline, 1 month
  description: The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.
  measure: Change in Migraine Disability Assessment Test (MIDAS) Scores
  time frame: Baseline, 2 months
  description: The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.
  measure: Change in Migraine Disability Assessment Test (MIDAS) Scores
  time frame: Baseline, 3 months
  description: The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.
  measure: Change in Migraine Disability Assessment Test (MIDAS) Scores
  time frame: Baseline, 6 months
  description: The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability.
  measure: Change Migraine Symptom Severity Scale (MSSS)
  time frame: Baseline, 1 month
  description: A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.
  measure: Change Migraine Symptom Severity Scale (MSSS)
  time frame: Baseline, 2 month
  description: A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.
  measure: Change Migraine Symptom Severity Scale (MSSS)
  time frame: Baseline, 3 month
  description: A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.
  measure: Change Migraine Symptom Severity Scale (MSSS)
  time frame: Baseline, 6 month
  description: A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed.
  measure: Change in Pain Catastrophizing Scale (PCS)
  time frame: Baseline, 1 month
  description: The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.
  measure: Change in Pain Catastrophizing Scale (PCS)
  time frame: Baseline, 2 month
  description: The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.
  measure: Change in Pain Catastrophizing Scale (PCS)
  time frame: Baseline, 3 month
  description: The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.
  measure: Change in Pain Catastrophizing Scale (PCS)
  time frame: Baseline, 6 month
  description: The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.
  arm group label: Empowered Relief (ER) class
  arm group type: Experimental
  description: Daily Diaries
  arm group label: Health Education (HE) class
  arm group type: Experimental
  arm group label: Empowered Relief (ER) class and Health Education (HE) class
  arm group type: Experimental
  description: If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
  arm group label: Treatment as Usual (TAU)
  arm group type: Other
  intervention type: Behavioral
  intervention name: Empowered Relief
  description: This is a single-session (2-hour) behavioral intervention utilizing pain psychology principles (cognitive-behavioral therapy for pain, pain neuroscience education).
  Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions.
  Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes.
  In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life.
  arm group label: Empowered Relief (ER) class
  arm group label: Empowered Relief (ER) class and Health Education (HE) class
  intervention type: Behavioral
  intervention name: Health Education (HE)
  description: This is a single-session (2-hour) health education class reviewing principles of medically indicated self-management of migraine headaches (e.g., consistent dietary and hydration habits, exercise, understanding of and adherence to medical treatment regimens).
  Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions.
  Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes.
  In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life.
  arm group label: Empowered Relief (ER) class and Health Education (HE) class
  arm group label: Health Education (HE) class
  intervention type: Behavioral
  intervention name: Treatment as Usual
  description: Participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life. In addition, participants will complete daily diaries for 28 days.
  If participants are interested in attending classes that were not part of this group assignment, participants will be invited to do so after completing the 6-month follow-up questionnaire.
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John Sturgeon, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Anthony Fauser
  phone: 734-998-7034
  email: fausera@umich.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: John Sturgeon
  investigator title: Assistant Professor of Anesthesiology
  mesh term: Migraine Disorders
  sharing ipd: Yes
  ipd description: De-identified datasets including participant self-report data (baseline, follow-up and daily diary-based assessments) will be maintained and made available to external researchers upon request via the Inter-University Consortium for Political and Social Research (ICPSR) data repository at University of Michigan.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: De-identified datasets will be made available after publication of the primary study results and/or at the conclusion of the National Institute of Neurological Disorders and Stroke (NINDS)-funded grant study period (currently December 2026, barring any no-cost extension. Data will remain available for at least 3 years beyond the end date of the study.
  ipd access criteria: Data may be shared with other investigators interested in learning more about the nature of behavioral interventions for individuals with chronic migraine. All datasets will be de-identified and shared only after interested researchers contact ICPSR and complete a restricted data use agreement.
  The data and associated documentation will be made available to users only under a restricted data-sharing agreement through ICPSR that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI and ICPSR through the University of Michigan.