PACE Versus PE for CPTSD (PACE Trial)
Condition(s) studied
Investigational drug(s) / intervention(s)
PACE: 26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy).
PE: 25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
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).
Eligibility
Primary outcome measure(s)
- ITI — End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07371156 on ClinicalTrials.gov ↗ ← All trials in Denmark