PACE Versus PE for CPTSD (PACE Trial)

Sofie Folke

Status: Not yet enrolling

Conditions: Complex Posttraumatic Stress Disorder

Treatments: Other: PE; Other: PACE

Study type: Interventional

Funder types: Other

Identifiers

NCT07371156

PACE trial

H-25066014 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 2 patient groups

PACE

Experimental group

Description:

Patient-centred Modular Cognitive Behavioural Therapy

Treatment:

Other: PACE

PE

Active Comparator group

Description:

Prolonged Exposure therapy

Treatment:

Other: PE