[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05663034":3,"trial-entities:NCT05663034":140,"trial-summary:NCT05663034":145},{"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":29,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":52,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":125,"overall_officials":133,"references":138,"see_also_links":139},"NCT05663034","IRB00356930","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","RECRUITING","2027-06","2026-07","2026-07-13","2024-05-10","Johns Hopkins University","OTHER",true,"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).","This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia. A cohort of n=360 adults with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia will be randomized to receive either telemedicine-delivered CBT-I or MBTI. Consistent with previous scientific literature, the interventions will be standardized and six sessions in length. All participants will wear an actigraph wrist monitor throughout the course of the project. All participants will also complete electronic sleep diaries throughout the course of the project. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, ambulatory EEG sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment (12- and 24-weeks post randomization, respectively). The primary outcome is insomnia severity (ISI) and secondary outcomes are pre-sleep arousal, and depressive symptoms (PSAS; Patient Health Questionnaire (PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).",[19,20,21,22,23,24,25,26,27,28],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[19,20,30,21,31,27,32,33,34],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","INTERVENTIONAL","TREATMENT",[38],"NA",{"count":40,"type":41},360,"ESTIMATED",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47},"BEHAVIORAL","Mindfulness-based treatment for insomnia (MBTI)","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",[45],{"type":44,"name":49,"description":50,"armGroupLabels":51},"Cognitive behavioral therapy for insomnia (CBT-I)","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.",[49],[53],{"measure":54,"description":55,"timeFrame":56},"Change in Insomnia severity as assessed by the insomnia severity index (ISI)","Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms","At the end of treatment, and 2-, 6- and 12-weeks post treatment",[],"ALL","18 Years",null,false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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.",[67,68],"ADULT","OLDER_ADULT",[70,84,89,101,113],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":81},"Intrepid Spirit Center - Eglin Air Force Base","Eglin Air Force Base","Florida","32542","United States",[77],{"name":78,"role":79,"phone":80},"Mary Fergus","CONTACT","240-204-1573",{"lat":82,"lon":83},30.45907,-86.55026,{"facility":85,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":86,"geoPoint":88},"Naval School Explosive Ordance Disposal - Eglin Air Force Base",[87],{"name":78,"role":79,"phone":80},{"lat":82,"lon":83},{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":75,"contacts":94,"geoPoint":98},"Walter Reed National Medical Military Center","Bethesda","Maryland","20814",[95],{"name":96,"role":79,"phone":97},"Seyi Gbade-Alabi","301-550-0350",{"lat":99,"lon":100},38.98067,-77.10026,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":75,"contacts":106,"geoPoint":110},"Womack Army Medical Center","Fort Bragg","North Carolina","28310",[107],{"name":108,"role":79,"phone":109},"Katherine Dermers","301-550-0352",{"lat":111,"lon":112},35.139,-79.00603,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":75,"contacts":118,"geoPoint":122},"Madigan Army Medical Center","Fort Lewis","Washington","98431",[119],{"name":120,"role":79,"phone":121},"Rachel Satter","301-550-0353",{"lat":123,"lon":124},47.06171,-122.58344,[126,130],{"name":127,"role":79,"phone":128,"email":129},"Luis Buenaver, PHD","4105507986","lbuenav1@jhmi.edu",{"name":131,"role":79,"email":132},"Elizabeth Wysocki, MS","ewysock2@jhu.edu",[134],{"name":135,"affiliation":136,"role":137},"Luis Buenaver, PhD","Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":141,"biomarkers":144},[21,20,142,143],"Posttraumatic state","Traumatic Encephalopathy",[],{"nct_id":4,"found":15,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a randomized controlled trial with two groups, meaning participants will be randomly assigned to receive either CBT-I or MBTI. It is a single-blind study, so you won't know which treatment you're getting. The study plans to enroll 360 participants.","completed","CBT-I vs. MBTI for TBI-Related Insomnia and PTSD Symptoms","This study is comparing two types of therapy for people who have trouble sleeping (insomnia) and post-traumatic stress symptoms (PTSS) after a traumatic brain injury (TBI). The therapies are Cognitive Behavioral Therapy for Insomnia (CBT-I) and Mindfulness-Based Treatment for Insomnia (MBTI). Both are 6-week programs delivered remotely. Researchers want to see which therapy is more effective at improving sleep and reducing symptoms of depression. You might be able to join if you are a current or former member of the uniform services, had a TBI and insomnia for more than 90 days, and have an Insomnia Severity Index (ISI) score above 10. The study aims to enroll 360 participants.","Participants will be followed for 12 weeks after treatment (or 24 weeks after randomization) to assess changes in insomnia severity and other symptoms.",109,"You will participate in a 6-week therapy program delivered remotely. You will also complete questionnaires, neurocognitive tests, sleep diaries, and wear a wrist monitor. Assessments will happen at the start, end of treatment, and at 2, 6, and 12 weeks after treatment.","Not stated in the trial record.",[45,49],"v2"]