[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558505":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":61,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Therapy for Insomnia","ACTIVE_COMPARATOR","6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.",[13],"Behavioral: Cognitive Behavioral Therapy for Insomnia",{"label":15,"type":10,"description":16,"interventionNames":17},"Brief Behavioral Therapy for Insomnia","4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.",[18],"Behavioral: Brief Behavioral Therapy for Insomnia",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL",[9],null,{"type":21,"name":15,"description":16,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"affiliation":5,"role":29},"Kristi E Pruiksma, PhD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Isabella McElwain, B.S.","CONTACT","254-226-6987","Isabella.l.mcelwain.ctr@health.mil",{"name":37,"role":33,"phone":38,"phoneExt":23,"email":39},"Kristi E. Pruiksma, Ph.D.","210 562 6700","pruiksma@uthscsa.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Carl R. Darnall Army Medical Center","RECRUITING","Fort Cavazos","Texas","76544","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-97.77561,31.13489,{"lat":53,"lon":52},[56,59],{"name":57,"role":33,"phone":58,"phoneExt":23,"email":23},"Scot D Engel, PsyD","(254) 287-7281",{"name":28,"role":33,"phone":60,"phoneExt":23,"email":39},"(210) 562-6700",{"type":29,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Kristi Pruiksma","Associate Professor",[65,68],{"name":66,"class":67},"Congressionally Directed Medical Research Programs","FED",{"name":69,"class":70},"Hope Health Research Institute","UNKNOWN","100558505","behavioral-insomnia-treatment-in-mild-traumatic-brain-injury-100558505",false,"NCT06551987","Behavioral Insomnia Treatment in Mild Traumatic Brain Injury","Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Active duty U.S. military service members.\n* At least 18 years of age.\n* Ability to provide informed consent and follow study-related instructions.\n* Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.\n* At least 2 postconcussive symptoms scored \\> 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.\n* Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)\\_No Split Week Self-Assessment of Sleep Survey (SASS-Y).\n* Minimum score of 15 on the Insomnia Severity Index (ISI).\n* Plans to be in the area for the next 3 months.\n* Stable on psychotropic and hypnotic medications for at least 1 month.\n* Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.\n\nExclusion Criteria:\n\n* Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.\n* Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.\n* Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.\n* Planned major surgery.\n* Pregnancy, assessed by self-report and review of medical record.","ALL","18 Years","45 Years",{"count":82,"type":83},160,"ESTIMATED","INTERVENTIONAL",[86],"NA","This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).",[89,90],"Insomnia","Mild Traumatic Brain Injury",[9,15,89,90,92],"Active Duty Military Personnel","2026-01-06",{"date":95,"type":96},"2026-01-07","ACTUAL",{"date":98,"type":96},"2024-12-03",{"date":100,"type":83},"2027-09-01",{"name":5,"class":6},1]