NCT06755710 Patient Engagement in PTSD Treatment (PEP)
| NCT ID | NCT06755710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 427 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2028-02-29 |
Trial Parameters
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Brief Summary
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. The main questions the study aims to answer are: * Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome? * 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? Participants 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. The treatment for all patients will last between 8-13 months.
Eligibility Criteria
In- and exclusion criteria of the randomised controlled trial for Psychotherapeutic Unit Inclusion Criteria: * Adults (18 years or older) * PTSD pursuant to the ICD-10 research criteria * Signed informed consent * patients referred to "Main Level" treatment Exclusion Criteria: * 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/or depression. * Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26). In- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry: Inclusion criteria: * Adult (18 years or older) * Refugees or persons who have been family reunified with a refugee * PTSD pursuant to the ICD-10 research criteria * Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or
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