Patient-centred Modular Cognitive Behavioural Therapy Versus Prolonged Exposure Therapy for Complex Post-traumatic Stress Disorder: a Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 228
- Locations
- 10
- Primary Endpoint
- ITI
Study Overview
Brief 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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors, data managers, statisticians, and conclusion drawers will be blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Please note that participants need to be invited in order to take part in the trial.
Arms & Interventions
PACE
Patient-centred Modular Cognitive Behavioural Therapy
Intervention: PACE (Other)
PE
Prolonged Exposure therapy
Intervention: PE (Other)
Outcomes
Primary Outcomes
ITI
Time Frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)
Secondary Outcomes
- SAE(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- Suicides and suicide attempts(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- DASS-21, depression(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- DASS-21, anxiety(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- AUDIT(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- WHO-5(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
- SDS(End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation))
Investigators
Sofie Folke
PhD, Psychologist, Senior Researcher
Danish Veterans Centre