Complex Posttraumatic Stress DisorderPACENCT07371156
PACE Versus PE for CPTSD (PACE Trial)
A study testing PACE and PE in people with Complex Posttraumatic Stress Disorder, run by Sofie Folke at 10 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Posttraumatic Stress Disorder
- What is being tested?
- PACE and PE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 10 sitesDenmark
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sofie Folke contact
10 sites in 1 country
Denmark10 sites
The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospital Psychiatry
Aarhus, 8200
Mikkel Arendt
The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region of Denmark
Ballerup Municipality, 2750
Clas Winding
Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117
Birkerød, 3460
Sofie Folke
Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3
Copenhagen, 2100
Sofie Folke
Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110
Fredericia, 7000
Sofie Folke
Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1
Holstebro, 7500
Sofie Folke
Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30
Karup, 7470
Sofie Folke
Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34
Nørresundby, 9400
Sofie Folke
Danish Veterans Centre - Ringsted: Ringsted Kaserne, Garnisonen 1
Ringsted, 4100
Sofie Folke
Danish Veterans Centre - Slagelse: Antvorskov Kaserne, Charlottedal Allé 4
Slagelse, 4200
Sofie Folke
About this study
Official title: Patient-centred Modular Cognitive Behavioural Therapy Versus Prolonged Exposure Therapy for Complex Post-traumatic Stress Disorder: a Randomised Trial
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).
Read the detailed description
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.
- Conditions
- Complex Posttraumatic Stress Disorder
- Being tested
- PACE, PE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACEOther
26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy).
PEOther
25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
| Study group | Role | What they receive |
|---|---|---|
| PACE | Experimental | Patient-centred Modular Cognitive Behavioural Therapy Receives: Other: PACE |
| PE | Active comparator | Prolonged Exposure therapy Receives: Other: PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITI
CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)
Measured: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)).
Measured: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofie Folke
- Sponsor type
- Other government
- Collaborators
- Danish Veterans Centre, Aarhus University Hospital, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Sofie Folke, Danish Veterans Centre
- Investigators
- Sofie Folke, Principal investigator, Military Psychology Department, Danish Veterans Centre, part of Defence Command Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371156
- Sponsor's protocol ID
- PACE trial
- Other IDs
- H-25066014
- Acronym
- PACE
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centred Modular Cognitive Behavioural Therapy Versus Prolonged Exposure Therapy for Complex Post-traumatic Stress Disorder: a Randomised Trial
- ClinicalTrials.gov ID
- NCT07371156
- Acronym / sponsor ID
- PACE / PACE trial
- Conditions
- Complex Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Sofie FolkeOther government
- Collaborators
- Danish Veterans Centre, Aarhus University Hospital, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial
| Arm | Type | Receives |
|---|---|---|
| PACE | Experimental | Other: PACEPatient-centred Modular Cognitive Behavioural Therapy |
| PE | Active comparator | Other: PEProlonged Exposure therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACE26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy). | Other | PACE |
| PE25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes). | Other | PE |
Primary outcome
ITI
Time frame: 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)
7 secondary outcomes
SAE
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Suicides and suicide attempts
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, depression
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, anxiety
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
AUDIT
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
WHO-5
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
SDS
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofie Folke contact
Sofie Folke principal investigator
Military Psychology Department, Danish Veterans Centre, part of Defence Command Denmark
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACE and PE in people with Complex Posttraumatic Stress Disorder, run by Sofie Folke at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Folke (+45 7281 9700, VETC-KTP-PACE@mil.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITI (time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.