[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06170281":3,"trial-entities:NCT06170281":108,"trial-summary:NCT06170281":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":73,"locations":76,"central_contacts":91,"overall_officials":93,"references":96,"see_also_links":107},"NCT06170281","24-006447","Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial","A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention","NOT_YET_RECRUITING","2028-12-01","2026-06","2026-06-16","2026-12","Mayo Clinic","OTHER",false,"This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.","After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -\n\n* Choice Arm: allowed to choose from a menu of migraine behavioral treatment options\n* Random: randomized to migraine behavioral treatment options.\n\nAfter 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.",[19,20,21,22],"Migraine","Headache","Chronic Migraine","Headache Disorders",[24,25,26],"migraine","headache","behavioral intervention","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},24,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Migraine Behavioral Treatment","Migraine Behavioral Treatment involving daily activities",[40,41,42,43,44,45],"Choice - ME","Choice - MS","Choice - SE","Random - ME","Random - MS","Random - SE",[47],{"measure":48,"description":49,"timeFrame":50},"Feasibility in terms of recruitment and adherence rates","recruitment rate, adherence rate","12 weeks",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Migraine Frequency","migraine day frequency","at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization",{"measure":57,"description":58,"timeFrame":55},"Headache Self-efficacy","headache self-efficacy measured using validated headache self-efficacy questionnaire",{"measure":60,"description":61,"timeFrame":55},"Migraine Intensity","migraine intensity, self-reported","ALL","18 Years",null,{"inclusion":66,"exclusion":69,"raw_text":72},[67,68],"have chronic migraine for a minimum of 1-year","aged 18 years and older",[70,71],"secondary headache disorders","children younger than 18 years old","Inclusion Criteria:\n\n* have chronic migraine for a minimum of 1-year\n* aged 18 years and older\n\nExclusion Criteria:\n\n* secondary headache disorders\n* children younger than 18 years old",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":13,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Phoenix","Arizona","85054","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Yohannes W. Woldeamanuel, MD","CONTACT","480-342-1385","Woldeamanuel.YohannesWoubishet@mayo.edu",{"lat":89,"lon":90},33.44838,-112.07404,[92],{"name":84,"role":85,"phone":86,"email":87},[94],{"name":84,"affiliation":13,"role":95},"PRINCIPAL_INVESTIGATOR",[97,101,104],{"pmid":98,"type":99,"citation":100},"32071349","BACKGROUND","Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038\u002Fs41598-020-59738-1.",{"pmid":102,"type":99,"citation":103},"26810728","Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007\u002Fs00415-016-8031-5. Epub 2016 Jan 25.",{"pmid":105,"type":99,"citation":106},"34357593","Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002\u002Fcncr.33844. Epub 2021 Aug 6.",[],{"nct_id":4,"conditions":109,"biomarkers":110},[21],[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study with 24 planned participants. After a screening period, you would be assigned to either choose your behavioral treatment or have one randomly assigned.","completed","Migraine Behavioral Treatment Study","This study is exploring different combinations of Migraine Behavioral Treatment to find the most effective approach for people with chronic migraine. It also looks at whether being able to choose your treatment affects how well it works. To join, you must be at least 18 years old and have experienced chronic migraine for at least one year. The study aims to see if it's practical to recruit participants and if they stick with the treatments, with success measured by how many people complete the 12-week study. The current recruitment status is unclear.","Your migraine frequency will be compared between groups at the end of the 12-week study period.",92,"You would participate in a 4-week screening period, followed by 12 weeks of Migraine Behavioral Treatment delivered virtually. Your migraine frequency would be assessed after 6 weeks and again at 12 weeks.","Not stated in the trial record.",[37],"v2"]