Patient Engagement in PTSD Treatment (PEP)

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.

NCT Number	NCT06755710
Lead Sponsor	Herlev and Gentofte Hospital
Conditions	PTSD, Depression Disorders, Patient Engagement
Enrollment	427 participants
Start Date	2025-01-02
Primary Completion	2028-02-29 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-14