PACE Versus PE for CPTSD (PACE Trial)

CPTSD symptom severity assessed with the International Trauma Interview (ITI), (scale ranging from 0-48, higher scores indicate higher severity)

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.

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.

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).

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).

Alcohol use problems, assessed using the Alcohol Use Disorders Identification Test (AUDIT), (scale from 0-40, higher scores indicate greater risk).

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).

Level of functioning, assessed using the Sheehan Disability Scale (SDS), (scale ranging from 0 (unimpaired) to 30 (highly impaired)).

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)

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).

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).

Level of perceived social support, assessed with the Crisis Support Scale (CSS), (scale ranging from 6-42, higher scores indicate greater perceived social support).

Health-related quality of life, assessed using the European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L). Index score (score between -1 and 1, higher scores indicate better health).

Dissociative symptoms, assessed using the Dissociative Symptoms Scale (DSS), Scale ranging from 0 to 80, higher scores indicate greater dissociative symptom severity).

Moral injury-related distress, assessed using the Moral Injury Outcome Scale (MIOS), (scale ranging from 0 to 56, higher scores indicate greater moral injury-related distress).

Insomnia severity, assessed using the Insomnia Severity Index (ISI), (scale ranging from 0 (no problem) to 28 (severe insomnia)).

Symptoms of stress, assessed using the stress subscale from the Depression Anxiety Stress Scales-21 items (DASS-21), (scale ranging from 0-42, higher scores indicate higher severity of stress symptoms).

Drug use problems, assessed using the Drug Use Disorders Identification Test (DUDIT), (scale from 0-44, higher scores indicate greater risk of drug-related disorders).