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Trauma-focused therapy in people at risk of psychosis

A feasibility study of eye-movement desensitization and reprocessing (EMDR) in people with an at-risk mental state (ARMS) for psychosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31976295
Enrollment
20
Registered
2018-05-03
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis Mental and Behavioural Disorders Unspecified organic or symptomatic mental disorder

Interventions

Current interventions as of 01/08/2019: We originally planned to randomise all consented participants to one of the two groups: 1) EMDR or 2) TAU. Randomization took place by means of a computerized

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026