Complex Posttraumatic Stress Disorder
Conditions
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.
Interventions
Sponsors
Sofie Folke
Danish Veterans Centre
Aarhus University Hospital
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Study design
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.
Intervention model description
Investigator-initiated, multi-centre, parallel group, randomised clinical superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ITI | 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
| Measure | Time frame | Description |
|---|---|---|
| SAE | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | 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. |
| Suicides and suicide attempts | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | 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. |
| DASS-21, depression | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | 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). |
| DASS-21, anxiety | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | 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). |
| AUDIT | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | Alcohol use problems, assessed using the Alcohol Use Disorders Identification Test (AUDIT), (scale from 0-40, higher scores indicate greater risk). |
| WHO-5 | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | 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). |
| SDS | End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation) | Level of functioning, assessed using the Sheehan Disability Scale (SDS), (scale ranging from 0 (unimpaired) to 30 (highly impaired)). |
Countries
Denmark
Contacts
CONTACTSofie Folke
PRINCIPAL_INVESTIGATORSofie Folke
Military Psychology Department, Danish Veterans Centre, part of Defence Command Denmark
Outcome results
None listed