[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652032":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Written Exposure Therapy","EXPERIMENTAL","Participants assigned to this arm will complete five weekly Written Exposure Therapy sessions. In each session, participants will complete structured writing exercises focused on a traumatic experience. EEG, actigraphy, and clinical assessments will be collected at scheduled time points before treatment, during the five-week intervention period, and after treatment.",[13],"Behavioral: Written Exposure Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Neutral Writing Condition","ACTIVE_COMPARATOR","Participants assigned to this arm will complete five weekly neutral writing sessions that do not involve trauma-focused exposure. EEG, actigraphy, and clinical assessments will be collected at scheduled time points before the intervention, during the five-week intervention period, and after the intervention.",[19],"Behavioral: Neutral Writing Condition",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Written Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Mohammad Sendi, PhD","CONTACT","617-855-4236","msendi@mclean.harvard.edu",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Oaks Building","Belmont","Massachusetts","02478","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-71.17867,42.39593,{"lat":47,"lon":46},{"type":50,"investigatorFullName":31,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Assistant Neuroscientist","100652032","eeg-and-actigraphy-biomarkers-of-written-exposure-therapy-for-posttraumatic-stress-disorder-100652032",false,"NCT07766798","EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder","Trauma Recovery Via EEG and Actigraphy Tracking (TREAT): Biomarkers of Written Exposure Therapy in PTSD","TREAT","Inclusion Criteria:\n\n1. Age between 18 and 65\n2. History of trauma, with current elevated PTSD symptoms\n3. Ability to understand and sign informed consent\n4. Ability to read and write in English\n5. Stable psychotropic medications for at least six weeks prior to enrollment\n\nExclusion Criteria:\n\n1. Metal in the head\u002Fneck\n2. Current unstable medical conditions\n3. Head injury with prolonged loss of consciousness (over 30 minutes) within the past 10 years\n4. History of major neurological illness\n5. History of seizures\n6. History of central nervous system (CNS) tumors\n7. History of stroke\n8. History of cerebral aneurysm\n9. Currently receiving trauma-focused therapy\n10. Current benzodiazepine use\n11. Currently receiving non-pharmacological treatment e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)\n12. Current moderate or severe substance use disorder\n13. Lifetime Bipolar I or primary psychotic illness\n14. Pregnancy","ALL","18 Years","65 Years",{"count":64,"type":65},200,"ESTIMATED","INTERVENTIONAL",[68],"NA","Posttraumatic stress disorder, or PTSD, can affect emotional health, sleep, daily functioning, and quality of life. Written Exposure Therapy is a brief trauma-focused psychotherapy in which participants complete structured writing exercises about a traumatic experience. However, it is not yet clear which changes in brain activity and sleep occur over the course of treatment or whether these measures can help predict who is most likely to benefit.\n\nThis study will enroll approximately 200 adults with PTSD. Participants will be randomly assigned to either Written Exposure Therapy or a neutral writing condition and will complete five weekly writing sessions. The study will collect electroencephalography, or EEG, recordings and actigraphy-based sleep and activity measures at scheduled time points before treatment, during the five-week intervention period, and after treatment. Participants will also complete clinical assessments of PTSD symptoms and related outcomes.\n\nThe primary goals are to identify EEG and sleep-related biomarkers associated with improvement in PTSD symptoms, determine how early these biomarkers change during treatment, and evaluate whether baseline measures can help predict individual treatment response.",[71],"Posttraumatic Stress Disorder (PTSD)",[9,73,74,75,76],"Electroencephalography","Actigraphy","Treatment Response","Biomarkers","NOT_YET_RECRUITING","2026-08-10",{"date":80,"type":81},"2026-08-17","ACTUAL",{"date":83,"type":65},"2026-09-01",{"date":85,"type":65},"2031-09-30",{"name":5,"class":6},1]