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PACE Versus PE for CPTSD (PACE Trial)

NCT07371156 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-08-14

No results posted yet for this study

Summary

The objective of this pragmatic trial is to evaluate the beneficial and harmful effects of Patient-centred Modular Cognitive Behavioural Therapy (PACE) compared with the standard post-traumatic stress disorder (PTSD) treatment, Prolonged Exposure (PE), for adults with an ICD-11 diagnosis of Complex post-traumatic stress disorder (CPTSD).

Conditions

  • Complex Posttraumatic Stress Disorder

Interventions

OTHER

PACE

26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy).

OTHER

PE

25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).

Sponsors & Collaborators

  • Danish Veterans Centre

    collaborator OTHER_GOV

  • Aarhus University Hospital

    collaborator OTHER

  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Sofie Folke

    lead OTHER_GOV

Principal Investigators

  • Sofie Folke · Military Psychology Department, Danish Veterans Centre, part of Defence Command Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-03-31
Completion
2029-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371156 on ClinicalTrials.gov