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PACE Versus PE for CPTSD (PACE Trial)

NCT07371156 · tracked via the Priya Life Science Denmark tracker
Sponsor
Sofie Folke
Phase
Not applicable
Started
2026-10-01
Last updated
2026-09-09

Condition(s) studied

Complex Posttraumatic Stress Disorder

Investigational drug(s) / intervention(s)

PACEPE

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Please note that participants need to be invited in order to take part in the trial.

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)

FacilityCityRegionStatus
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
Official registry record

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