protocolSection identificationModule nctId: NCT06279598, orgStudyIdInfo id: UniversityGroningen, briefTitle: PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD, acronym: PT-STRESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2031-05-20, completionDateStruct date: 2032-08-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Groningen, class: OTHER, collaborators name: Dimence, descriptionModule briefSummary: The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.Key questions:1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?Secondary goals:* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;* Investigating how much the quality of the therapeutic alliance influences outcomes.Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom., conditionsModule conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 442, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged Exposure therapy, interventions name: Eye Movement Desensitization Reprocessing (EMDR), interventions name: Interpersonal Psychotherapy (IPT), outcomesModule primaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), secondaryOutcomes measure: International Trauma Questionnaire (ITQ), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Mental Health Continuum Short Form (MHC-SF), secondaryOutcomes measure: Positive and Negative Experiences of Psychotherapy questionnaire (PNEP), otherOutcomes measure: Age, otherOutcomes measure: Gender, otherOutcomes measure: Education, otherOutcomes measure: Employment, otherOutcomes measure: Marital status, otherOutcomes measure: Ethnicity/race, otherOutcomes measure: Medication use, otherOutcomes measure: Treatment history, otherOutcomes measure: Mini-Schedules for Clinical Assessment in Neuropsychiatry (mini-SCAN), otherOutcomes measure: Life Events Checklist for DSM-5 (LEC-5), otherOutcomes measure: The Childhood Trauma Questionnaire-Short Form (CTQ-SF), otherOutcomes measure: Symptom Checklist-90 (SCL-90), Hostility subscale, otherOutcomes measure: Experiences in Close Relationships-Relationship Structures (ECR-RS), otherOutcomes measure: The Brief Experiental Avoidance Questionnaire (BEAQ), otherOutcomes measure: Improving Access to Psychological Therapies (IAPT), otherOutcomes measure: Posttraumatic Cognitions Inventory (PTCI), otherOutcomes measure: Trauma Related Guilt Inventory (TRGI), otherOutcomes measure: Trauma Related Shame Iventory (TRSI), otherOutcomes measure: Working Alliance Questionnaire shortened version (WAV-12), otherOutcomes measure: Expectancy rating (patients and therapists), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dimence, status: RECRUITING, city: Deventer, country: Netherlands, contacts name: Maarten K van Dijk, PhD, role: CONTACT, phone: +31 0570-604000, email: m.vandijk@dimence.nl, contacts name: Dominique Jonkers, Master, role: CONTACT, phone: +31 038-4692300, email: d.jonkers@dimence.nl, geoPoint lat: 52.255, lon: 6.16389, hasResults: False