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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
228
The Outpatient Clinic for PTSD, Department of Affective Disorders, Aarhus University Hospital Psychiatry
Aarhus, Denmark
The Outpatient Clinic for PTSD at Ballerup, Mental Health Centre Ballerup, Capital Region of Denmark
Ballerup Municipality, Denmark
Danish Veterans Centre - Høvelte: Livgardens Kaserne, Høveltevej 117
ITI
CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
SAE
Proportion of participants with at least one serious adverse event (SAE) during the intervention period, assessed via patient medical records by a blinded outcome adjudication committee. SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalisation or prolonging of existing hospitalisation, and resulted in persistent or significant disability or jeopardised the participant.
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
Suicides and suicide attempts
Proportion of participants with a suicide- or a suicide attempt during the intervention period, assessed via patient medical records by a blinded outcome adjudication committee.
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, depression
Symptoms of depression, assessed using the depression subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of depression symptoms).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
DASS-21, anxiety
Symptoms of anxiety, assessed using the anxiety subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of anxiety symptoms).
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Birkerød, Denmark
Danish Veterans Centre - Svanemøllen: Svanemøllens Kaserne, Ryvangs Allé 1-3
Copenhagen, Denmark
Danish Veterans Centre - Fredericia: Ryes Kaserne, Treldevej 110
Fredericia, Denmark
Danish Veterans Centre - Holstebro: Jydske Dragonregiment, Dragonkasernen 1
Holstebro, Denmark
Danish Veterans Centre - Karup: Flyvestation Karup, Herningvej 30
Karup, Denmark
Danish Veterans Centre - Aalborg: Aalborg Kaserner, Gl. Høvej 34
Nørresundby, Denmark
Danish Veterans Centre - Ringsted: Ringsted Kaserne, Garnisonen 1
Ringsted, Denmark
Danish Veterans Centre - Slagelse: Antvorskov Kaserne, Charlottedal Allé 4
Slagelse, Denmark
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
AUDIT
Alcohol use problems, assessed using the Alcohol Use Disorders Identification Test (AUDIT), (scale from 0-40, higher scores indicate greater risk).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
WHO-5
Mental well-being, assessed using the World Health Organization-Five Well-Being Index (WHO-5), (percentage score from 0-100, higher scores indicate better well-being).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)
SDS
Level of functioning, assessed using the Sheehan Disability Scale (SDS), (scale ranging from 0 (unimpaired) to 30 (highly impaired)).
Time frame: End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)