An interventional study of PACE and PE in Complex Posttraumatic Stress Disorder, sponsored by Sofie Folke. Not yet recruiting at 10 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Sofie Folke · Not applicable, Interventional, and Treatment
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).
This trial is designed as an investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial of PACE versus standard PTSD treatment, PE, for ICD-11 CPTSD. The total sample size will be 228 participants. The trial will take place at the Danish Veteran Centre and two clinics in the Mental Health Services in Denmark. The participants will be adult military veterans and psychiatric outpatients with ICD-11 CPTSD. After giving their consent, participants will be randomly assigned (1:1) to receive either PACE or PE.
The experimental intervention will be 26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy). The control intervention will be 25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
Outcome assessors, data managers, statisticians, and conclusion drawers will be blinded to group allocation. The primary outcome will be clinician-rated ICD-11 CPTSD symptom severity assessed with the International Trauma Interview (ITI) at 9 months after randomisation. Secondary outcomes include serious adverse events, suicide attempts, symptoms of depression, stress, and anxiety, alcohol use problems, mental well-being, and functional impairment assessed at 9 months after randomisation.
This is the only study on the registry with Sofie Folke as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Please note that participants need to be invited in order to take part in the trial.
Patient-centred Modular Cognitive Behavioural Therapy
Other: PACE
Prolonged Exposure therapy
Other: PE
26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy).
25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
ITI
CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
SAE
Proportion of participants with at least one serious adverse event (SAE) during the intervention period, assessed via patient medical records by a blinded outcome adjudication committee. SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalisation or prolonging of existing hospitalisation, and resulted in persistent or significant disability or jeopardised the participant.
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Suicides and suicide attempts
Proportion of participants with a suicide- or a suicide attempt during the intervention period, assessed via patient medical records by a blinded outcome adjudication committee.
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, depression
Symptoms of depression, assessed using the depression subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of depression symptoms).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, anxiety
Symptoms of anxiety, assessed using the anxiety subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of anxiety symptoms).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
AUDIT
Alcohol use problems, assessed using the Alcohol Use Disorders Identification Test (AUDIT), (scale from 0-40, higher scores indicate greater risk).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
WHO-5
Mental well-being, assessed using the World Health Organization-Five Well-Being Index (WHO-5), (percentage score from 0-100, higher scores indicate better well-being).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
SDS
Level of functioning, assessed using the Sheehan Disability Scale (SDS), (scale ranging from 0 (unimpaired) to 30 (highly impaired)).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
ITQ
Symptoms of ICD-11 complex PTSD, assessed with the International Trauma Questionnaire (ITQ), (a total symptom severity score will be calculated by summing PTDS items (P1-P6) and Disturbances in Self-Organization (items C1-C6) symptoms, yielding a score ranging from 0-48, with higher scores indicating greater CPTSD symptom severity)
Time frame: 3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
TIQ
Trauma-related identity, assessed with the Trauma Identity Questionnaire, (scale ranging from 0 to 105 with higher scores representing presence of negative identity characteristics associated with traumatic experiences).
Time frame: 3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
ETMQ
Sensory and cognitive-emotional qualities of traumatic memories, assessed with the Experiences of Traumatic Memories Questionnaire (ETMQ), (scores range from 0-32 with higher scores reflecting more intense sensation-based trauma memories).
Time frame: 3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
CSS
Level of perceived social support, assessed with the Crisis Support Scale (CSS), (scale ranging from 6-42, higher scores indicate greater perceived social support).
Time frame: 3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
EQ-5D-5L
Health-related quality of life, assessed using the European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L). Index score (score between -1 and 1, higher scores indicate better health).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DSS
Dissociative symptoms, assessed using the Dissociative Symptoms Scale (DSS), Scale ranging from 0 to 80, higher scores indicate greater dissociative symptom severity).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
MIOS
Moral injury-related distress, assessed using the Moral Injury Outcome Scale (MIOS), (scale ranging from 0 to 56, higher scores indicate greater moral injury-related distress).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
ISI
Insomnia severity, assessed using the Insomnia Severity Index (ISI), (scale ranging from 0 (no problem) to 28 (severe insomnia)).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, stress
Symptoms of stress, assessed using the stress subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of stress symptoms).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DUDIT
Drug use problems, assessed using the Drug Use Disorders Identification Test (DUDIT), (scale from 0-44, higher scores indicate greater risk of drug-related disorders).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.