[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632436":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":61,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BREATHE with Headache (BREATHE-HA)","EXPERIMENTAL","Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program",[13],"Behavioral: BREATHE with Headache (BREATHE-HA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced Standard-of-Care: Headache Education","ACTIVE_COMPARATOR","Headache education, delivered as a telehealth group program",[19],"Behavioral: Enhanced Standard-of-Care: Headache Education",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","BREATHE-HA is a 6-session group mindfulness-based intervention delivered via telehealth for adolescents with migraine. The intervention was adapted from an empirically-supported mindfulness-based intervention for adolescents (Learning to BREATHE; Broderick, 2021). Example activities include breath awareness, body scanning, mindful eating, loving-kindness practice, and mindful movement, as well as activities and discussion focused on improving distress tolerance and enhancing self-care, with examples related to living with migraine.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Enhanced Standard-of-Care is a 6-session group headache education program delivered via telehealth. It will be derived from a manual with fidelity as an attention-matched control in a behavioral trial for pediatric migraine. Headache education will include didactics and discussion on headache symptoms, medication, lifestyle factors for pain management, communication with providers, education on mood\u002Fstress, and impact of headaches on school and family.",[15],[30],{"name":31,"affiliation":5,"role":32},"Michelle A Clementi, Ph.D.","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","720-777-7487","michelle.clementi@childrenscolorado.org",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Michelle T Harmon, B.S.","720-777-4904","michelle.harmon@childrenscolorado.org",[43],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Children's Hospital Colorado","Aurora","Colorado","80045","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-104.83192,39.72943,{"lat":54,"lon":53},[57,58],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62,65],{"name":63,"class":64},"National Center for Complementary and Integrative Health (NCCIH)","NIH",{"name":66,"class":64},"National Institute of Neurological Disorders and Stroke (NINDS)","100632436","headache-education-and-awareness-vs-daily-mindfulness-strategies---understanding-pain-100632436",false,"NCT07513662","Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain","Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine","HEADS-UP","Inclusion Criteria:\n\n* Age 12 to 17 years old\n* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition\n* Patient report of at least 6 headache days per month\n* At least mild headache-related disability, as assessed by PedMIDAS score \\> 10\n* Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment\n* Adolescent participant fluent in English for the intervention content\n\nExclusion Criteria:\n\n* Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months\n* Current psychiatric crisis (e.g., active suicidal ideation)\n* Cognitive impairments or developmental delays that interfere with their ability to participate in the study\n* Inability to provide consent\u002Fassent","ALL","12 Years","17 Years",{"count":79,"type":80},72,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this study (supported by and included in the NIH HEAL Initiative: https:\u002F\u002Fheal.nih.gov\u002F) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:\n\n1. Telehealth group mindfulness-based intervention\n2. Telehealth group headache education",[86,87],"Migraine","Migraine in Adolescence",[89,90,91,86,92,93,94],"Adolescent","Mindfulness","Mindfulness Intervention","Headache","Headache Education","Randomized controlled trial","NOT_YET_RECRUITING","2026-03-30",{"date":98,"type":99},"2026-04-07","ACTUAL",{"date":101,"type":80},"2026-09",{"date":103,"type":80},"2028-08",{"name":5,"class":6},1]