PACE Versus PE for CPTSD (PACE Trial) (NCT07371156) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PACE Versus PE for CPTSD (PACE Trial)
Denmark228 participantsStarted 2026-02-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
ITI
Timeframe: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)