PACE Versus PE for CPTSD (PACE Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSofie Folke
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
PACE
Other intervention26 hours PACE (delivered as 26 1-hour sessions of weekly individual psychotherapy).
PE
Other intervention25.5 hours PE therapy (17 sessions of weekly individual psychotherapy delivered for 90-minutes).
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: PACEExperimental treatment 1 intervention
Group B: PEActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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).
Time frame
End of intervention, 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)Other outcomes
1
ITQ
Symptoms of ICD-11 complex PTSD, assessed with the International Trauma Questionnaire (ITQ), (a total symptom severity score will be calculated by summing PTDS items (P1-P6) and Disturbances in Self-Organization (items C1-C6) symptoms, yielding a score ranging from 0-48, with higher scores indicating greater CPTSD symptom severity)
Time frame
3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)2
TIQ
Trauma-related identity, assessed with the Trauma Identity Questionnaire, (scale ranging from 0 to 105 with higher scores representing presence of negative identity characteristics associated with traumatic experiences).
Time frame
3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)3
ETMQ
Sensory and cognitive-emotional qualities of traumatic memories, assessed with the Experiences of Traumatic Memories Questionnaire (ETMQ), (scores range from 0-32 with higher scores reflecting more intense sensation-based trauma memories).
Time frame
3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)4
CSS
Level of perceived social support, assessed with the Crisis Support Scale (CSS), (scale ranging from 6-42, higher scores indicate greater perceived social support).
Time frame
3, 6, and 9 months after randomisation (and assessed as an exploratory outcome at 18 months after randomisation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sofie Folke
Lead sponsor
Danish Veterans Centre
Sponsor institution
Danish Veterans Centre
Collaborator
Aarhus University Hospital
Collaborator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov
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