[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574163":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":79,"collaborators":32,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":32,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":32,"overallStatus":63,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as usual (TAU)","ACTIVE_COMPARATOR","8-12 months of treatment Interventions: Behavioral: treamtent as usuan (TAU)",[13],"Behavioral: Treatment as Usual",{"label":15,"type":16,"description":17,"interventionNames":18},"Introductory PTSD module + TAU","EXPERIMENTAL","9-13 months of treatment An intervention with an introductory PTSD module consistent of four sessions focusing on motivation followed by TAU",[19,13],"Behavioral: Introductory PTSD module",{"label":21,"type":16,"description":22,"interventionNames":23},"Introductory PTSD module + one session of Shared Decision Making + individualised treatment","9-13 months of treatment Add-on introductory PTSD module and add-on patient-centred shared decision making session before continuing in the chosen standardised treatment.",[19,24,25],"Behavioral: Shared Decision Making","Behavioral: Standardised treatments",[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BEHAVIORAL","Introductory PTSD module","The Introductory PTSD module consist of four session focusing on motivation",[15,21],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Shared Decision Making","A patient-centred shared decision making session where one of four standardised treatments can be chosen",[21],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Treatment as Usual","Treatment as usual",[15,9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Standardised treatments","One of four treatments Treatment as ususal Sessions with psychologists Sessions with nurses Sessions with medical doctors",[21],[46],{"name":47,"affiliation":48,"role":49},"Jessica Carlsson","Mental Health Services in th Capital Region, Denmark","STUDY_CHAIR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Anna Bolette L. Nielsen, Medical Doctor","CONTACT","+4538646181","anna.bolette.lund.nielsen.03@regionh.dk",{"name":57,"role":53,"phone":58,"phoneExt":32,"email":59},"Laura E. Fonnesbaek, Authorised psychologist","+4538645010","laura.eybye.fonnesbaek@regionh.dk",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Mental Health Centre Ballerup","RECRUITING","Ballerup Municipality","Capital Region","2750","Denmark","DK",{"type":70,"coordinates":71},"Point",[72,73],12.36328,55.73165,{"lat":73,"lon":72},[76],{"name":77,"role":53,"phone":78,"phoneExt":32,"email":55},"Anna B.L. Nielsen, MD","+4538646180",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Anna Bolette Lund Nielsen","MD","100574163","patient-engagement-in-ptsd-treatment-pep-100574163",false,"NCT06755710","Patient Engagement in PTSD Treatment (PEP)","Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes","PEP","In- and exclusion criteria of the randomised controlled trial for Psychotherapeutic Unit\n\nInclusion Criteria:\n\n* Adults (18 years or older)\n* PTSD pursuant to the ICD-10 research criteria\n* Signed informed consent\n* patients referred to \"Main Level\" treatment\n\nExclusion Criteria:\n\n* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and\u002For depression.\n* Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).\n\nIn- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry:\n\nInclusion criteria:\n\n* Adult (18 years or older)\n* Refugees or persons who have been family reunified with a refugee\n* PTSD pursuant to the ICD-10 research criteria\n* Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.\n* Signed informed consent\n\nExclusion criteria:\n\n* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and\u002For depression.\n* Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).","ALL","18 Years",{"count":94,"type":95},427,"ESTIMATED","INTERVENTIONAL",[98],"NA","The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials.\n\nThe main questions the study aims to answer are:\n\n* Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome?\n* Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement?\n\nParticipants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will receive treatment as usual (TAU), one arm is the first intervention group where the participants will receive an Introductory PTSD module consisting of four sessions focusing on enhancing motivation for PTSD treatment, before continuing in TAU. The last arm is the second intervention group, which will only take place at CTP. Here the patient will receive the Introductory PTSD module followed by a session of Shared Decision Making, where the participant together with the MD decides which of four standardized treatment courses they will receive.\n\nThe treatment for all patients will last between 8-13 months.",[101,102,103],"PTSD","Depression Disorders","Patient Engagement","2025-04-08",{"date":106,"type":107},"2025-04-09","ACTUAL",{"date":109,"type":107},"2025-01-02",{"date":111,"type":95},"2028-08-31",{"name":5,"class":6},1]