Not Yet RecruitingNot Applicable

PACE Versus PE for CPTSD (PACE Trial)

Denmark228 participantsStarted 2026-08-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: ≥18 years. * Referred to PTSD treatment (which requires absence of severe psychiatric comorbidity dominating the clinical presentation, hindering trauma-focused psychotherapy, assessed by the referring clinician at point of referral (e.g. major depressive disorder, ADHD, autism spectrum disorders, personality disorders, psychotic disorders, alcohol- or substance use, and aggressive behaviours)). * Diagnosis of CPTSD according to ICD-11, assessed by the interviewing investigator using the ITI interview. * Written informed consent. Exclusion Criteria: * Current self-harm or severe suicidality defined as at least one self-harm episode or one suicide-attempt the last three months, as assessed by the interviewing investigator. * Any other condition that markedly compromises the participant's ability to adhere to the treatment programme or follow-up, such IQ \< 70 based on clinical judgement. * Currently involved in legal proceedings concerning work accident compensation related to PTSD, or trial regarding child custody. * Does not understand Danish or needs an interpreter.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ITI

Timeframe: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)

Trial details

NCT IDNCT07371156

SponsorSofie Folke

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

Sofie Folke

+45 7216 3251 VETC-KTP-PACE@mil.dk

View on ClinicalTrials.gov More Complex Posttraumatic Stress Disorder trials