Psychosis Mental and Behavioural Disorders Unspecified organic or symptomatic mental disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Those aged 16 years or over who are at risk of psychosis (as defined in the Comprehensive Assessment of At-Risk Mental States (CAARMS) (A. R. Yung et al., 2005) 2. Presence of at least one positive symptom (perceptual abnormality, unusual thought, or non-bizarre ideas) scored =3 on CAARMS 3. History of traumatic experience as defined in ICD-10 F43.1, occurring prior to onset of first positive symptom 4. Presence of 1 or more symptoms of re-living, avoidance, hyper-arousal, or cognitive distortions in relation to the traumatic experience (assessed using the PTSD Checklist for DSM-V (PCL5) during the last month (Bovin et al., 2016))
Exclusion criteria
Exclusion criteria: 1. People with past history of treated or untreated psychotic illness or learning disability 2. Current use of antipsychotics 3. Currently receiving psychological therapy 4. Completed a trauma-focused psychological therapy in the last 2 years 5. Insufficient fluency in English 6. Lacking mental capacity to provide valid informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transition to psychosis assessed at 12 months post-randomization from clinical records (measured as an ICD-10 diagnosis of psychosis) or, if patients have dropped out of the Early Intervention Services, researchers will invite participants for an appointment where, via the CAARMS, it will be established whether they transitioned to psychosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/08/2019: 1. Severity of psychotic symptoms, measured using CAARMS, PSYRAT, the negative scale of the PANSS, and CAPE-42 2. Severity of PTSD symptoms, measured using PCL-5 3. Severity of depression and anxiety, measured using PHQ-9 and GAD-7 4. Impaired functioning, measured using Work and Social Adjustment Scale (WSAS) 5. Health status, measured using EQ-5D-L 6. Drug use, measured using DAST 10 7. Medication use, measured with self-report questionnaires 8. Resource data use, measured with self-report questionnaires All secondary outcomes apart from resource data use will be assessed at baseline, 4, 8 and 12 months after the baseline assessment. Resource use will be assessed only at 4, 8 and 12 months after the baseline assessment. Previous secondary outcome measures: 1. Severity of psychotic symptoms, measured using PANSS, PSYRAT and CAPE-42 2. Severity of PTSD symptoms, measured using PCL-5 3. Severity of depression and anxiety, measured using PHQ-9 and GAD-7 4. Impaired functioning, measured using Work and Social Adjustment Scale (WSAS) 5. Health status, measured using EQ-5D-L 6. Drug use, measured using DAST 10 7. Medication use, measured with self-report questionnaires 8. Resource data use, measured with self-report questionnaires All secondary outcomes apart from resource data use will be assessed at baseline, 4, 8 and 12 months post-randomization. Resource use will be assessed only at 4, 8 and 12 months post randomization. | — |
Countries
England, United Kingdom