protocolSection identificationModule nctId: NCT06318195, orgStudyIdInfo id: 2023-06821-01, briefTitle: Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care., acronym: CiPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska Universitetssjukhuset, descriptionModule briefSummary: The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Acute Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Condensed Internet delivered prolonged exposure (CIPE), outcomesModule primaryOutcomes measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5), secondaryOutcomes measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress., otherOutcomes measure: Participants satisfaction with treatment., otherOutcomes measure: Adverse events related to treatment., otherOutcomes measure: Number of completed treatment modules, otherOutcomes measure: Number of messages sent and received in the digital platform, otherOutcomes measure: Number of completed home work assignments by the participant during the treatment period, otherOutcomes measure: The proportion of participants that conducts the weekly measures and further assessment points, otherOutcomes measure: The proportion of participants that go through the entire treatment period, otherOutcomes measure: Number of drop-outs from treatment, otherOutcomes measure: Rates of inclusion to the study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin, city: Stockholm, country: Sweden, contacts name: Charlotte Gentili, PhD, role: CONTACT, phone: +46760482895, email: charlotte.s.gentili@regionstockholm.se, contacts name: Mike Kemani, PhD, role: CONTACT, email: mike.kemani@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False