PACE Versus PE for CPTSD (PACE Trial)

Starting soon · Not applicable

Conditions studied: Complex Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT07371156

Run by

Sofie Folke

People needed

228

Starts

2026-08-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospital Psychiatry — Aarhus, Denmark
• The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region of Denmark — Ballerup Municipality, Denmark
• Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117 — Birkerød, Denmark
• Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3 — Copenhagen, Denmark
• Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110 — Fredericia, Denmark
• Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1 — Holstebro, Denmark
• Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30 — Karup, Denmark
• Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34 — Nørresundby, Denmark
• Danish Veterans Centre - Ringsted: Ringsted Kaserne, Garnisonen 1 — Ringsted, Denmark
• Danish Veterans Centre - Slagelse: Antvorskov Kaserne, Charlottedal Allé 4 — Slagelse, Denmark

Full record on ClinicalTrials.gov

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