[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497572":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":61,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)","EXPERIMENTAL","B-Tf-CBT shares key features with Internet-based CBT (I-CBT) in that it is based on a digital support accessible to the patient. This digital support equips blended treatment with the same proposed advantages as I-CBT in terms of improving treatment accessibility, adherence, and reducing therapist-time. In addition, incorporating 6 biweekly face-to-face sessions to facilitate and augment delivery of more demanding components of TF-CBT such as memory exposure.",[13],"Behavioral: Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Prolonged exposure","ACTIVE_COMPARATOR","Gold standard Tf-CBT Prolonged exposure will constitute the control condition. Prolonged exposure will be delivered by trained therapists under supervision adhering to the evidence based manual delivered face-to-face over 9-15 weeks.",[19],"Behavioral: Prolonged exposure",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A gold standard trauma-focused CBT delivered with face-to-face sessions with a therapist.",[15],[30],{"name":31,"affiliation":32,"role":33},"Sigrid Salomonsson, PhD","Karolinska institute, clinical neuroscience","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","0708442283","Sigrid.salomonsson@ki.se",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Johan Lundin, PhD student","Johan.lundin.1@ki.se",[43],{"facility":5,"status":44,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Stockholm","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],18.06871,59.32938,{"lat":52,"lon":51},[55,57],{"name":31,"role":36,"phone":56,"phoneExt":25,"email":38},"+46708442283",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Sigrid Salomonsson","Principal investigator, PhD",[62,64,66],{"name":63,"class":6},"Capio Group",{"name":65,"class":6},"Stockholm University",{"name":67,"class":68},"Region Stockholm","OTHER_GOV","100497572","blended-treatment-fr-ptsd-a-new-format-of-computer-assisted-trauma-focused-cognitive-behavioral-therapy-100497572",false,"NCT05758987","Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy","Evaluation of Blended CBT for PTSD in Regular Care: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy: A Randomized Controlled Non-inferiority Trial","Inclusion Criteria:\n\n* PTSD according to Diagnostic and Statistical Manual of mental disorders 5 as primary problem\n* ≥ 18 years\n* Basic knowledge of speaking and writing Swedish\n* No other psychological treatment at the same time\n* No ongoing threats or violence\n* If antidepressant medication, stable dose 6 weeks before starting treatment\n* Have access to the internet and a computer\n* Willingness\u002Fability to participate after receiving information about what participation entails\n\nExclusion Criteria:\n\n* Other diagnosis or problem is assessed as primary to PTSD\n* Moderate to severe suicidal risk\n* PTSD from childhood trauma that the person cannot remember","ALL","18 Years",{"count":79,"type":80},160,"ESTIMATED","INTERVENTIONAL",[83],"NA","A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE).\n\nResearch question and hypothesis\n\nPrimary\n\n1. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 post-treatment?\n\n   Secondary:\n2. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 at 6 and 12 months follow up?\n3. Are there significant differences between bTF-CT and PE when delivered in routine clinical care in terms of depression, anxiety, insomnia, functionality, complex PTSD, other PTSD-measures and treatment satisfaction post-treatment and at 6 and 12 months follow up?\n\nThe study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.",[86,87],"PTSD","CBT","2025-12-19",{"date":90,"type":91},"2025-12-26","ACTUAL",{"date":93,"type":91},"2023-03-10",{"date":95,"type":80},"2027-10-10",{"name":5,"class":6},1]