[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486949":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":182,"collaborators":185,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":41,"eligibilityCriteria":210,"healthyVolunteers":206,"sex":211,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":41,"studyType":217,"phases":218,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":59,"whyStopped":41,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinic-based Cognitive Behavioral Therapy (CCBT)","ACTIVE_COMPARATOR","CCBT provides CBT for posttraumatic headache through 8 face-to-face, in-clinic sessions.",[13],"Behavioral: Cognitive Behavioral Therapy for Posttraumatic Headache",{"label":15,"type":10,"description":16,"interventionNames":17},"Telemedicine-based Cognitive Behavioral Therapy (TCBT)","TCBT provides 8-sessions of CBT for posttraumatic headache using telemedicine technology rather than attending in-office sessions. Additionally, TCBT includes instructions for each session specific to the mechanics of a telehealth encounter (e.g., asking participant for name, location, and accessible phone number for location in case of technical failure or crisis). All TCBT participants must be enrolled at the MTF or VA from which they were recruited, and the treatment facility will be notified that they are receiving TCBT in case a crisis arises and needs to be managed by the site.",[18],"Other: Telemedicine-based Cognitive Behavioral Therapy (TCBT)",{"label":20,"type":10,"description":21,"interventionNames":22},"Treatment As Usual","Participants will continue to engage in clinical care as usual for 8 weeks. Research staff will call the TAU participants weekly to assess for adverse events. Research staff at each site will be trained on standardized assessment of usual care activities using forms adapted from our single-site trial.",[23],"Other: Treatment as Usual",[25,32,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Cognitive Behavioral Therapy for Posttraumatic Headache","CBT for Posttraumatic Headaches consists of 8 sessions of cognitive behavioral therapy that focus on (1) discussions and exercises that increase awareness of what may be related to headaches, (2) relaxation techniques to manage physiological stress, and (3) problem-solving techniques to manage common stressors. Sessions are delivered weekly and can last between 45 to 75 minutes based on clinical content and patient response to the material.",[9],[31],"CCBT",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Treatment as Usual","Participants will continue to engage in medical care as usual for 8 weeks.",[20],[37],"TAU or TPU",{"type":6,"name":15,"description":39,"armGroupLabels":40,"otherNames":41},"Participants assigned to TCBT will receive 8 sessions of cognitive behavioral therapy using telemedicine rather than face-to face office visits.",[15],null,[43],{"name":44,"affiliation":5,"role":45},"Donald D McGeary, PhD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},"Nicole A Brackins, MS","CONTACT","210-450-8076","brackins@uthscsa.edu",{"name":53,"role":49,"phone":54,"phoneExt":41,"email":55},"Fermin A Carrizales","210-562-6724","carrizalesF@uthscsa.edu",[57,79,96,107,118,135,152,169],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"VA Greater Los Angeles Healthcare System","RECRUITING","Los Angeles","California","90073","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-118.24368,34.05223,{"lat":69,"lon":68},[72,77],{"name":73,"role":49,"phone":74,"phoneExt":75,"email":76},"Rocio Vallejo","310-478-3711","42647","rocio.vallejo@va.gov",{"name":78,"role":45,"phone":41,"phoneExt":41,"email":41},"Revati Mummaneni, MD",{"facility":80,"status":59,"city":81,"state":61,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"VA Palo Alto Health Care System","Palo Alto","94304",{"type":66,"coordinates":84},[85,86],-122.14302,37.44188,{"lat":86,"lon":85},[89,94],{"name":90,"role":49,"phone":91,"phoneExt":92,"email":93},"Marisol Duran, MA","650-493-5000","62846","marisol.duran@va.gov",{"name":95,"role":45,"phone":41,"phoneExt":41,"email":41},"Molly Timmerman, DO",{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":63,"countryCode":64,"cosmosGeoPoint":102,"geoPoint":106,"contacts":41},"Tripler Army Medical Center (Desmond Doss Health Clinic, Schofield Barracks)","ACTIVE_NOT_RECRUITING","Honolulu","Hawaii","96819",{"type":66,"coordinates":103},[104,105],-157.85833,21.30694,{"lat":105,"lon":104},{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":63,"countryCode":64,"cosmosGeoPoint":113,"geoPoint":117,"contacts":41},"Walter Reed National Military Medical Center","WITHDRAWN","Bethesda","Maryland","20889",{"type":66,"coordinates":114},[115,116],-77.10026,38.98067,{"lat":116,"lon":115},{"facility":119,"status":59,"city":120,"state":121,"zip":122,"country":63,"countryCode":64,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Minneapolis VA Health Care System","Minneapolis","Minnesota","55417",{"type":66,"coordinates":124},[125,126],-93.26384,44.97997,{"lat":126,"lon":125},[129,133],{"name":130,"role":49,"phone":131,"phoneExt":41,"email":132},"Chay'La Hart","612-467-2924","Chay'La.Hart@va.gov",{"name":134,"role":45,"phone":41,"phoneExt":41,"email":41},"Rebecca Vogsland, DPT",{"facility":136,"status":59,"city":137,"state":138,"zip":139,"country":63,"countryCode":64,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Carl R. Darnall Army Medical Center (Fort Cavazos)","Killeen","Texas","76544",{"type":66,"coordinates":141},[142,143],-97.7278,31.11712,{"lat":143,"lon":142},[146,150],{"name":147,"role":49,"phone":148,"phoneExt":41,"email":149},"Paul Fowler","254-288-1638","Fowlerp@UTHSCSA.edu",{"name":151,"role":45,"phone":41,"phoneExt":41,"email":41},"Scot Engel, PsyD",{"facility":153,"status":59,"city":154,"state":138,"zip":155,"country":63,"countryCode":64,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"South Texas Veterans Health Care System","San Antonio","78229",{"type":66,"coordinates":157},[158,159],-98.49363,29.42412,{"lat":159,"lon":158},[162,167],{"name":163,"role":49,"phone":164,"phoneExt":165,"email":166},"Alex Carrizales","210-617-5300","114539","carrizalesf@uthscsa.edu",{"name":168,"role":45,"phone":41,"phoneExt":41,"email":41},"Ashley Lujan, DO",{"facility":170,"status":59,"city":154,"state":138,"zip":171,"country":63,"countryCode":64,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Brooke Army Medical Center","78234",{"type":66,"coordinates":173},[158,159],{"lat":159,"lon":158},[176,180],{"name":177,"role":49,"phone":178,"phoneExt":41,"email":179},"Moraima Rodriguez Guerrero","210-562-6709","rodriguezgue@uthscsa.edu",{"name":181,"role":45,"phone":41,"phoneExt":41,"email":41},"Alexis Nelson, MD",{"type":45,"investigatorFullName":183,"investigatorTitle":184,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Donald McGeary","Professor",[186,188,190,193,195,196,197,198,200,202],{"name":170,"class":187},"FED",{"name":189,"class":187},"C.R.Darnall Army Medical Center",{"name":191,"class":192},"Desmond Doss Health Clinic, Schofield Barracks","UNKNOWN",{"name":194,"class":187},"Minneapolis Veterans Affairs Medical Center",{"name":153,"class":187},{"name":80,"class":187},{"name":108,"class":187},{"name":199,"class":6},"Harvard University",{"name":201,"class":6},"University of California, Los Angeles",{"name":203,"class":187},"United States Department of Defense","100486949","multisite-advancement-of-research-on-chronic-posttraumatic-headache-100486949",false,"NCT05620719","Multisite Advancement of Research on Chronic Posttraumatic Headache","Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache","Inclusion Criteria:\n\n* Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with mild or moderate TBI whose headache began or exacerbated within 3 months of a head or neck injury.\n* Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent headache within the past 2 weeks).\n* At least moderate to severe headache-related disability based on a HIT-6 score greater than 50.\n* Participant is stable on headache medication at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks or study physician clinical judgement confirms stability; this includes botulinum toxin injections and devices like Cefaly).\n* Participant has a phone where they can receive reminders and complete the on-line Headache Diaries.\n* Participant speaks and reads\u002Funderstands English well enough to fully participate in the intervention and to reliably complete assessment measures.\n\nExclusion Criteria:\n\n* Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms.\n* Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment.\n* Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confirmed by a clinician through screening or review of clinical notes.\n* Participant demonstrates significant cognitive impairment that could impact treatment adherence\u002Fbenefit.","ALL","18 Years","70 Years",{"count":215,"type":216},525,"ESTIMATED","INTERVENTIONAL",[219],"NA","Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers\\* and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.\n\n\\*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.",[222],"Posttraumatic Headache",[224,225,226,227,228,229],"Cognitive Behavioral Therapy","Telehealth","Veterans","Military Service Members","Chronic Pain","Headaches","2026-06-22",{"date":232,"type":233},"2026-06-26","ACTUAL",{"date":235,"type":233},"2023-08-24",{"date":237,"type":216},"2027-08",{"name":5,"class":6},8]