RecruitingNot ApplicableNCT06755710

Patient Engagement in PTSD Treatment (PEP)

Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes


Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Enrollment

427 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an approach to improving patient engagement and personalization in PTSD (post-traumatic stress disorder) treatment programs — including both a standard psychiatric unit and a specialized center serving refugees and trauma survivors. **You may be eligible if...** - You are 18 or older with a diagnosed PTSD condition - You have signed informed consent - You are being referred to the main-level treatment program (standard group) - OR you are a refugee or family-reunified person who has experienced torture, organized violence, war, or political persecution (specialized group), with trauma occurring outside Denmark **You may NOT be eligible if...** - You have a severe, independent psychotic disorder (such as schizophrenia) - You have active alcohol or drug dependence Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntroductory PTSD module

The Introductory PTSD module consist of four session focusing on motivation

BEHAVIORALShared Decision Making

A patient-centred shared decision making session where one of four standardised treatments can be chosen

BEHAVIORALTreatment as Usual

Treatment as usual

BEHAVIORALStandardised treatments

One of four treatments Treatment as ususal Sessions with psychologists Sessions with nurses Sessions with medical doctors


Locations(1)

Mental Health Centre Ballerup

Ballerup Municipality, Capital Region, Denmark

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NCT06755710


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