NCT07371156

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Dec 2029

First Submitted

Initial submission to the registry

January 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

January 19, 2026

Last Update Submit

January 19, 2026

Conditions

Complex Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • ITI

    CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)

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

Secondary Outcomes (7)

  • SAE

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

  • Suicides and suicide attempts

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

  • DASS-21, depression

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

  • DASS-21, anxiety

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

  • AUDIT

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

  • +2 more secondary outcomes

Other Outcomes (10)

  • ITQ

    3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)

  • TIQ

    3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)

  • ETMQ

    3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)

  • +7 more other outcomes

Study Arms (2)

PACE

EXPERIMENTAL

Patient-centred Modular Cognitive Behavioural Therapy

Other: PACE

PE

ACTIVE COMPARATOR

Prolonged Exposure therapy

Other: PE

Interventions

PACEOTHER

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

PACE
PEOTHER

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

PE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospital Psychiatry

Aarhus, 8200, Denmark

Location

The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region of Denmark

Ballerup Municipality, 2750, Denmark

Location

Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117

Birkerød, 3460, Denmark

Location

Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3

Copenhagen, 2100, Denmark

Location

Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110

Fredericia, 7000, Denmark

Location

Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1

Holstebro, 7500, Denmark

Location

Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30

Karup, 7470, Denmark

Location

Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34

Nørresundby, 9400, Denmark

Location

Danish Veterans Centre - Ringsted: Ringsted Kaserne, Garnisonen 1

Ringsted, 4100, Denmark

Location

Danish Veterans Centre - Slagelse: Antvorskov Kaserne, Charlottedal Allé 4

Slagelse, 4200, Denmark

Location

Study Officials

  • Sofie Folke

    Military Psychology Department, Danish Veterans Centre, part of Defence Command Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Folke

CONTACT

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

Sofie Folke

CONTACT

VETC-MPA43@mil.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors, data managers, statisticians, and conclusion drawers will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Psychologist, Senior Researcher

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 27, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

After the results have been published, we aim to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When the results have been published.
Access Criteria
Researchers with a protocol for their planned study.

Locations

DK(10)