PACE Versus PE for CPTSD (PACE Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PACE, PE.
- Who it may be relevant to
- Registry conditions: Complex Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-centred Modular Cognitive Behavioural Therapy Versus Prolonged Exposure Therapy for Complex Post-traumatic Stress Disorder: a Randomised Trial
Overview
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.
Interventions
- Other PACE
26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy). - Other PE
25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
Primary outcome measures
- ITI [Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)]
Secondary outcome measures (7)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 10 centers
- The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospi — Aarhus
- The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region — Ballerup Municipality
- Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117 — Birkerød
- Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3 — Copenhagen
- Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110 — Fredericia
- Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1 — Holstebro
- Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30 — Karup
- Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34 — Nørresundby
- … and 2 more centers
Identifiers
NCT: NCT07371156 · PACE trial · H-25066014