PACE Versus PE for CPTSD (PACE Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSofie Folke
About this 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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PACE
- PE
Treatment groups
228 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sofie Folke
Lead sponsor
Danish Veterans Centre
Sponsor institution
Danish Veterans Centre
Collaborator
Aarhus University Hospital
Collaborator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov