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NCT07371156
PACE Versus PE for CPTSD (PACE Trial)
Conditions: Complex Posttraumatic Stress Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 228
Sponsor: Sofie Folke
Location: The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospital Psychiatry Aarhus
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).
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.
Source: ClinicalTrials.gov (NCT07371156). StuddyBuddy aggregates publicly available trial information.