[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611592":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":60,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prolonged Exposure","ACTIVE_COMPARATOR","Prolonged Exposure (PE) Arm:\n\nParticipants assigned to PE receive up to 12 weekly individual sessions delivered by trained clinicians following the standard PE manual. Treatment focuses on repeated, systematic confrontation with trauma-related memories (imaginal exposure) and avoided situations (in-vivo exposure) to reduce fear, distress, and maladaptive avoidance. Sessions include psychoeducation, breathing retraining, development of an exposure hierarchy, and structured review of homework assignments. Therapists monitor symptom fluctuations closely and coordinate with the OPUS clinical team. PE is provided in addition to participants' usual OPUS care, and all sessions follow predefined safety and fidelity procedures.",[13],"Behavioral: Prolonged Exposure",{"label":15,"type":10,"description":16,"interventionNames":17},"EMDR","Eye Movement Desensitization and Reprocessing (EMDR) Arm:\n\nParticipants assigned to EMDR receive up to 12 weekly individual sessions delivered by certified EMDR therapists using the standard eight-phase protocol. Treatment targets distressing trauma memories through brief, repeated exposure combined with bilateral stimulation (e.g., eye movements or tactile taps) to facilitate adaptive information processing. Sessions include history taking, identification of target memories, assessment of negative and positive cognitions, desensitization, installation, and body scan procedures. Therapists monitor symptom changes throughout and coordinate with OPUS clinicians as needed. EMDR is provided alongside usual OPUS care, with adherence ensured through protocol-based supervision and fidelity checks.",[18],"Behavioral: EMDR",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Distinguishing Features - Prolonged Exposure (PE) Arm\n\nThis intervention is distinguished by its exclusive reliance on systematic, therapist-guided exposure procedures grounded in emotional-processing theory. PE uses structured imaginal and in-vivo exposure to reduce avoidance and fear responses and does not employ bilateral stimulation, cognitive restructuring, or memory-processing elements characteristic of other trauma-focused approaches. The protocol follows a fixed sequence emphasizing habituation and extinction learning, making it operationally and mechanistically distinct from EMDR and from supportive or stabilization-oriented therapies used in similar clinical studies.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Distinguishing Features - EMDR Arm\n\nThis intervention is distinguished by its use of the standardized eight-phase EMDR protocol, which combines brief exposure to trauma memories with bilateral sensory stimulation to facilitate adaptive information processing. EMDR does not require prolonged or repeated imaginal exposure, fear-hierarchy construction, or systematic in-vivo exposure, differentiating it from PE and other exposure-based trauma treatments. Its mechanism centers on accelerating memory reprocessing rather than habituation, and the protocol includes unique components such as cognition rating, desensitization with bilateral stimulation, installation, and body scan procedures.",[15],[29],{"name":30,"affiliation":5,"role":31},"Nikolai Albert","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Nikolai Albert, MD, PhD","CONTACT","+45 29925014","nikolai.albert@regionh.dk",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Rikke Hilker, MD, PhD","+45 25775745","rikke.hilker@regionh.dk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":47,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Mental Health Centre Copenhagen","RECRUITING","Copenhagen","Denmark","2900","DK",{"type":51,"coordinates":52},"Point",[53,54],12.56553,55.67594,{"lat":54,"lon":53},[57,58,59],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},{"name":34,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":61,"investigatorFullName":30,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Associate professor","100611592","ps-trauma---development-of-trauma-treatment-for-patients-with-co-morbid-psychotic-disorders-and-traumas-100611592",false,"NCT07242586","PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas","PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.","PS-Trauma","Inclusion Criteria:\n\n* over 18 years of age Diagnosis within schizophrenia spectrum (ICD10 F2X) PTSD symptoms equivalent to above 31 on the PCL-5 Included in Early intervention services (OPUS) Talks and understands Danish\n\nExclusion Criteria:\n\n* Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month","ALL","18 Years","35 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"NA","Overview:\n\nPeople with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. This pilot study investigates whether two established trauma therapies can be delivered safely and acceptably to young adults with psychotic disorders receiving care in the OPUS early-intervention program.\n\nObjectives:\n\nThe main aim is to evaluate the feasibility and acceptability of two trauma-focused treatments-Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-in patients with psychotic disorders and post-traumatic stress symptoms. The study is not designed to test treatment efficacy but to determine whether a larger randomized controlled trial is practical.\n\nStudy Design:\n\nThis is a pilot and feasibility study. Twenty OPUS patients with a diagnosis within the schizophrenia spectrum and clinically relevant PTSD symptoms will be randomly assigned to either PE or EMDR. All participants continue their usual OPUS care while attending weekly trauma-focused therapy sessions.\n\nAssessments:\n\nAt baseline and follow-up, participants complete clinical interviews and questionnaires assessing trauma symptoms, psychotic symptoms, functioning, well-being, recovery experiences, and possible negative effects. Instruments include the PCL-5, CAPS-5, Mini-TALE, PANSS-6, PSP, WHO-5, Brief INSPIRE-O, NEQ, and CSQ.\n\nPrimary Feasibility Outcomes:\n\nRecruitment: At least 80% of the planned sample enrolled within 6 months.\n\nRetention: At least 70% completing ≥12 therapy sessions.\n\nAcceptability: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ).\n\nEligibility:\n\nInclusion:\n\nAge ≥18\n\nDiagnosis within the schizophrenia spectrum (ICD-10: F20-F29)\n\nPTSD symptom score \\>31 on PCL-5\n\nCurrent OPUS patient\n\nSufficient Danish language skills\n\nExclusion:\n\nSubstance use that prevents participation (e.g., attending sessions intoxicated)\n\nSevere cognitive impairment\n\nRecent changes in antipsychotic medication (within 1 month)\n\nRisks and Safety:\n\nTemporary increases in PTSD symptoms may occur when beginning trauma therapy; this pattern is well documented and typically followed by improvement. Previous studies show no higher risk of serious adverse events among patients with psychosis receiving trauma treatment compared with those who do not. Participants are closely monitored, and the study team works in continuous collaboration with OPUS clinicians. If a participant experiences significant clinical deterioration, the therapy can be paused or stopped, and supportive measures will be provided.\n\nPotential Benefits:\n\nParticipants may experience a reduction in trauma-related symptoms and gain access to a treatment that is not otherwise routinely offered to patients with psychotic disorders. The study may help improve future care for this underserved population.\n\nFunding:\n\nThe study is funded by the Nektar Foundation and conducted at the CORE Research Unit, Mental Health Services Copenhagen.",[82,83,84],"SCHIZOPHRENIA 1 (Disorder)","Schizotypal Disorder","Post Traumatic Stress Symptoms",[86,87,88,89,90,15],"First episode psychosis","Trauma","Schizophrenia","psychotherapy","prolonged exposure","2025-12-03",{"date":93,"type":94},"2025-12-10","ACTUAL",{"date":96,"type":94},"2025-10-02",{"date":98,"type":76},"2026-06-30",{"name":30,"class":6},1]