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NCT06755710: PEP

Patient Engagement in PTSD Treatment (PEP)

Recruiting now NA Last updated 9 April 2025
What this trial tests

NA trial testing Introductory PTSD module in PTSD in 427 participants. Currently enrolling.

Timeline
2 January 2025
Primary endpoint
29 February 2028
31 August 2028

Quick facts

Lead sponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment427
Start date2 January 2025
Primary completion29 February 2028
Estimated completion31 August 2028
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

18 and older, any sex, with PTSD or Depression Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for PTSD

Currently open trials in the same condition.

Other Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06755710.

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