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/NCT05987592</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00079570</org_study_id>
      <secondary_id>R01AT011502</secondary_id>
      <nct_id>NCT05987592</nct_id>
    </id_info>
    <brief_title>Be WELL With Migraine: Brain Education and WELLness With Migraine</brief_title>
    <official_title>Be WELL With Migraine: Brain Education and WELLness With Migraine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized clinical trial is to evaluate two different non-drug, virtual&#xD;
        treatment options designed to improve the lives of patients with migraine. Both interventions&#xD;
        involve 8 weekly sessions and an online platform with additional content and learning.&#xD;
        Participants can stay on all their medications during this study. Information from this study&#xD;
        may help determine how to better treat migraine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study involves 8 weekly virtual sessions &amp; an online platform designed to improve the&#xD;
        lives of patients with migraine. Participants from across the United States with migraine may&#xD;
        be eligible to participate. This study does not require any in-person visits. All assessments&#xD;
        and surveys will be completed virtually and/or online. Participants will independently&#xD;
        complete an initial online screen. Participants will attend a scheduled phone or&#xD;
        videoconferencing call with a study team member to complete the baseline assessment and learn&#xD;
        how to use the online platform. Participants will keep an online daily headache log and&#xD;
        complete several online surveys throughout the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 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>Parallel Assignment</intervention_model>
      <intervention_model_description>Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments, will be blinded.&#xD;
  In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS (&quot;mMIDAS&quot;) reduces recall bias and improves validity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>PHQ-8 has equivalent diagnostic depression accuracy as PHQ-9 and will be used to assess depression. PHQ-8 scores range from 0 to 24. Each of the 9 items can be scored from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>This 13-item scale quantifies an individual's pain experience. Unlike other scales, this does not require for the person to be in pain while completing it. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>A 25-item scale that assesses patient's beliefs in their ability to prevent and/or appropriately manage their headaches and headache-related disability; it has been shown to be valid and reliable. This scale consists of 25 items rated on a 7-point scale that ranges from 1 strongly disagree to 7 strongly agree. Total scores range from 0-175, higher scores reflect more self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks</measure>
      <time_frame>Post-intervention at 20 weeks</time_frame>
      <description>Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS (&quot;mMIDAS&quot;) reduces recall bias and improves validity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks</measure>
      <time_frame>Post-intervention at 32 weeks</time_frame>
      <description>Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS (&quot;mMIDAS&quot;) reduces recall bias and improves validity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>This is a 7-item scale that quantifies and assess the severity of generalized anxiety disorder, over the past 2 weeks - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks</measure>
      <time_frame>Immediately post-intervention at 8 weeks</time_frame>
      <description>Participants will complete a daily headache log (&lt;10 items) that captures frequency, along with a 7-day recall headache log (&lt;10 items).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">286</enrollment>
    <condition>Migraine</condition>
    <arm_group>
      <arm_group_label>Brain Education and WELLness with Migraine Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 weekly virtual sessions plus online platform</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Brain Education and WELLness with Migraine Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 weekly virtual sessions plus online platform</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brain Education and WELLness with Migraine Group A</intervention_name>
      <description>Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning</description>
      <arm_group_label>Brain Education and WELLness with Migraine Group A</arm_group_label>
      <other_name>Migraine Group A</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brain Education and WELLness with Migraine Group B</intervention_name>
      <description>Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning</description>
      <arm_group_label>Brain Education and WELLness with Migraine Group B</arm_group_label>
      <other_name>Migraine Group B</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of migraine with or without aura by with headache frequency of 4-20&#xD;
               days/month&#xD;
  &#xD;
            -  At least 1 year of migraine&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Able to participate in 8 weekly online classes&#xD;
  &#xD;
            -  Willingness to complete baseline headache logs&#xD;
  &#xD;
            -  Headache-related disability (Headache Impact Test (HIT)-6) score &gt;50&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Completion of technology onboarding with the online platform&#xD;
  &#xD;
            -  Pregnant women who are less than or equal to 16 weeks gestation at enrollment are&#xD;
               allowed to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major unstable medical/psychiatric condition that could be unsafe for participants or&#xD;
               for the group environment.&#xD;
  &#xD;
            -  Medication overuse headache, with migraine treatment&#xD;
  &#xD;
            -  Pregnant women who are more than 16 weeks gestation at enrollment&#xD;
  &#xD;
            -  Unstable migraine treatment at enrollment: any preventive treatment (oral or&#xD;
               injectable medication or neuromodulatory device) started within 12 weeks OR acute&#xD;
               treatment within 4 weeks to ensure stability&#xD;
  &#xD;
            -  Unwillingness to maintain stable current medication dosages for study duration&#xD;
  &#xD;
            -  Failure to complete baseline headache logs&#xD;
  &#xD;
            -  Heavy alcohol and illicit drug use&#xD;
  &#xD;
            -  Participation in another intervention clinical trial or one that would interfere in&#xD;
               this study&#xD;
  &#xD;
            -  Experience with stress reduction training (daily meditation practice, regular use of a&#xD;
               mindfulness app, or prior experience with MBSR)&#xD;
  &#xD;
            -  Any, and all other diagnoses or conditions which, in the opinion of the site&#xD;
               investigator, would prevent the patient from being a suitable candidate for the study&#xD;
               or interfere with the medical care needs of the study participant: COVID-positive test&#xD;
               within 30 days of enrollment&#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>Rebecca E Wells, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Junelyn Floyd</last_name>
      <phone>336-713-5776</phone>
      <email>jgfloyd@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cambridge Health Alliance - Center for Mindfulness and Compassion</name>
        <address>
          <city>Cambridge</city>
          <state>Massachusetts</state>
          <zip>02141</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alexandra Comeau</last_name>
        <email>acomeau@challiance.org</email>
      </contact>
      <investigator>
        <last_name>Paula Gardner, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zev Schuman-Oliver, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Junelyn Floyd</last_name>
        <phone>336-713-5776</phone>
        <email>jgfloyd@wakehealth.edu</email>
      </contact>
      <investigator>
        <last_name>Rebecca E Wells, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cincinnati Children's Hospital Medical Center</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45229-3039</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Leigh A Chamberlin</last_name>
        <email>LeighAnn.Chamberlin@cchmc.org</email>
      </contact>
      <investigator>
        <last_name>Scott Powers, PhD, ABPP</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>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Migraine</keyword>
    <keyword>Migraine without aura</keyword>
    <keyword>Migraine with aura</keyword>
    <keyword>behavioral</keyword>
    <keyword>mind-body</keyword>
    <keyword>integrative</keyword>
    <keyword>virtual</keyword>
    <keyword>online</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 data related to our outcome measures will be included in the IPD Sharing Statement (IPD) sharing plan, in addition to our study protocol, informed consent, and analytic plan.</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>After publication and within 12 months of completion of the analysis of study primary aims and ending within 36 months, anonymous and de-identified data will be made available on clinicaltrials.gov so that other investigators can verify or follow-up on the reported analyses.</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an IRB identified for this purpose - For individual participant data meta-analysis - Data will be made available on clinicaltrials.gov</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/NCT05987592
  org study id: IRB00079570
  secondary id: R01AT011502
  nct id: NCT05987592
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized clinical trial is to evaluate two different non-drug, virtual
        treatment options designed to improve the lives of patients with migraine. Both interventions
        involve 8 weekly sessions and an online platform with additional content and learning.
        Participants can stay on all their medications during this study. Information from this study
        may help determine how to better treat migraine.
  This study involves 8 weekly virtual sessions & an online platform designed to improve the
        lives of patients with migraine. Participants from across the United States with migraine may
        be eligible to participate. This study does not require any in-person visits. All assessments
        and surveys will be completed virtually and/or online. Participants will independently
        complete an initial online screen. Participants will attend a scheduled phone or
        videoconferencing call with a study team member to complete the baseline assessment and learn
        how to use the online platform. Participants will keep an online daily headache log and
        complete several online surveys throughout the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments, will be blinded.
  In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.
  measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
  measure: Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: PHQ-8 has equivalent diagnostic depression accuracy as PHQ-9 and will be used to assess depression. PHQ-8 scores range from 0 to 24. Each of the 9 items can be scored from 0 ("not at all") to 3 ("nearly every day"). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively.
  measure: Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: This 13-item scale quantifies an individual's pain experience. Unlike other scales, this does not require for the person to be in pain while completing it. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
  measure: Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: A 25-item scale that assesses patient's beliefs in their ability to prevent and/or appropriately manage their headaches and headache-related disability; it has been shown to be valid and reliable. This scale consists of 25 items rated on a 7-point scale that ranges from 1 strongly disagree to 7 strongly agree. Total scores range from 0-175, higher scores reflect more self-efficacy.
  measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
  time frame: Post-intervention at 20 weeks
  description: Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
  measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
  time frame: Post-intervention at 32 weeks
  description: Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
  measure: Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: This is a 7-item scale that quantifies and assess the severity of generalized anxiety disorder, over the past 2 weeks - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)
  measure: Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life
  measure: Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
  time frame: Immediately post-intervention at 8 weeks
  description: Participants will complete a daily headache log (<10 items) that captures frequency, along with a 7-day recall headache log (<10 items).
  arm group label: Brain Education and WELLness with Migraine Group A
  arm group type: Experimental
  description: 8 weekly virtual sessions plus online platform
  arm group label: Brain Education and WELLness with Migraine Group B
  arm group type: Experimental
  description: 8 weekly virtual sessions plus online platform
  intervention type: Behavioral
  intervention name: Brain Education and WELLness with Migraine Group A
  description: Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
  arm group label: Brain Education and WELLness with Migraine Group A
  other name: Migraine Group A
  intervention type: Behavioral
  intervention name: Brain Education and WELLness with Migraine Group B
  description: Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
  arm group label: Brain Education and WELLness with Migraine Group B
  other name: Migraine Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rebecca E Wells, MD, MPH
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Junelyn Floyd
  phone: 336-713-5776
  email: jgfloyd@wakehealth.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Migraine Disorders
  sharing ipd: Yes
  ipd description: De-identified data related to our outcome measures will be included in the IPD Sharing Statement (IPD) sharing plan, in addition to our study protocol, informed consent, and analytic plan.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: After publication and within 12 months of completion of the analysis of study primary aims and ending within 36 months, anonymous and de-identified data will be made available on clinicaltrials.gov so that other investigators can verify or follow-up on the reported analyses.
  ipd access criteria: Investigators whose proposed use of the data has been approved by an IRB identified for this purpose - For individual participant data meta-analysis - Data will be made available on clinicaltrials.gov