Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06755710

Patient Engagement in PTSD Treatment (PEP)

Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2025-04-09

427

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Patient Engagement in PTSD Treatment (PEP)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • PTSD diagnosis according to ICD-10 research criteria
  • Signed informed consent
  • For Psychotherapeutic Unit: patients referred to "Main Level" treatment
  • For Competence Centre of Transcultural Psychiatry: refugees or persons reunified with refugees
  • For Competence Centre of Transcultural Psychiatry: psychological trauma experienced outside Denmark including imprisonment, torture, organized violence, political persecution, war, or civil war experiences
Not Eligible

You will not qualify if you...

  • Severe psychotic disorder diagnosed as ICD-10 F2x or F30.1-F31.9 unless psychotic symptoms are part of PTSD or depression
  • Active dependence and use of drugs or alcohol (ICD-10 F1x.24-F1x.26)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mental Health Centre Ballerup

Ballerup Municipality, Capital Region, Denmark, 2750

Actively Recruiting

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Research Team

A

Anna Bolette L. Nielsen, Medical Doctor

CONTACT

L

Laura E. Fonnesbaek, Authorised psychologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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