[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053319":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":110,"collaborators":112,"id":116,"slug":24,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":24,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":24,"enrollmentInfo":124,"targetDuration":24,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":142,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive behavioral therapy for insomnia (CBT-I)","ACTIVE_COMPARATOR","CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.",[13],"Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)",{"label":15,"type":10,"description":16,"interventionNames":17},"Mindfulness-based treatment for insomnia (MBTI)","MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).",[18],"Behavioral: Mindfulness-based treatment for insomnia (MBTI)",[20,25],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia",[15],null,{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.",[9],[29],{"name":30,"affiliation":31,"role":32},"Luis Buenaver, PhD","Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Luis Buenaver, PHD","CONTACT","4105507986","lbuenav1@jhmi.edu",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Elizabeth Wysocki, MS","ewysock2@jhu.edu",[43,61,68,82,96],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Intrepid Spirit Center - Eglin Air Force Base","RECRUITING","Eglin Air Force Base","Florida","32542","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.55026,30.45907,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":24,"email":24},"Mary Fergus","240-204-1573",{"facility":62,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Naval School Explosive Ordance Disposal - Eglin Air Force Base",{"type":52,"coordinates":64},[54,55],{"lat":55,"lon":54},[67],{"name":59,"role":36,"phone":60,"phoneExt":24,"email":24},{"facility":69,"status":45,"city":70,"state":71,"zip":72,"country":49,"countryCode":50,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Walter Reed National Medical Military Center","Bethesda","Maryland","20814",{"type":52,"coordinates":74},[75,76],-77.10026,38.98067,{"lat":76,"lon":75},[79],{"name":80,"role":36,"phone":81,"phoneExt":24,"email":24},"Seyi Gbade-Alabi","301-550-0350",{"facility":83,"status":45,"city":84,"state":85,"zip":86,"country":49,"countryCode":50,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Womack Army Medical Center","Fort Bragg","North Carolina","28310",{"type":52,"coordinates":88},[89,90],-79.00603,35.139,{"lat":90,"lon":89},[93],{"name":94,"role":36,"phone":95,"phoneExt":24,"email":24},"Katherine Dermers","301-550-0352",{"facility":97,"status":45,"city":98,"state":99,"zip":100,"country":49,"countryCode":50,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Madigan Army Medical Center","Fort Lewis","Washington","98431",{"type":52,"coordinates":102},[103,104],-122.58344,47.06171,{"lat":104,"lon":103},[107],{"name":108,"role":36,"phone":109,"phoneExt":24,"email":24},"Rachel Satter","301-550-0353",{"type":111,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[113],{"name":114,"class":115},"Congressionally Directed Medical Research Programs","FED","100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":125,"type":126},360,"ESTIMATED","INTERVENTIONAL",[129],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[132,133,134,135,136,137,138,139,140,141],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[132,133,143,134,144,140,145,146,147],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","2026-07-10",{"date":150,"type":151},"2026-07-13","ACTUAL",{"date":153,"type":151},"2024-05-10",{"date":155,"type":126},"2027-06",{"name":5,"class":6},5]