Patient Engagement in PTSD Treatment (PEP)

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.

Conditions

• PTSD
• Depression Disorders
• Patient Engagement

Interventions

BEHAVIORAL

Introductory PTSD module

The Introductory PTSD module consist of four session focusing on motivation

BEHAVIORAL

Shared Decision Making

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

BEHAVIORAL

Treatment as Usual

Treatment as usual

BEHAVIORAL

Standardised treatments

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

Sponsors & Collaborators

• Mental Health Services in the Capital Region, Denmark

  lead OTHER

Principal Investigators

• Jessica Carlsson · Mental Health Services in th Capital Region, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-02

Primary Completion

2028-02-29

Completion

2028-08-31

Countries

• Denmark

Study Locations