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NCT06755710: PEP
Patient Engagement in PTSD Treatment (PEP)
NA trial testing Introductory PTSD module in PTSD in 427 participants. Currently enrolling.
29 February 2028
Quick facts
| Lead sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 427 |
| Start date | 2 January 2025 |
| Primary completion | 29 February 2028 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Introductory PTSD module
- Shared Decision Making
- Treatment as Usual
- Standardised treatments
Conditions studied
- PTSD — all drugs for PTSD →
- Depression Disorders — all drugs for Depression Disorders →
- Patient Engagement — all drugs for Patient Engagement →
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.
Verify or expand the search:
- PubMed search for NCT06755710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06755710 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Last refreshed: 9 April 2025
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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