Eye movement desensitization and reprocessing therapy in early psychosis

Eye movement desensitization and reprocessing therapy in early psychosis (EYES): a feasibility randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16262847

Enrollment

Registered

2019-03-28

Start date

2019-03-01

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Schizophrenia, schizotypal and delusional disorders Mental and Behavioural Disorders

Interventions

60 patients who have been ill for a maximum of three years will be randomly assigned to either Eye Movement Desensitisation and Reprocessing adapted for psychosis (EMDRp) plus Treatment As Usual (TAU)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged at least 16 years 2. Capacity and willingness to provide informed consent 3. ICD diagnosis of schizophrenia-spectrum disorders (ICD codes F20, F22, F23, F25, F28, F29; ICD-11 codes 6A20, 6A21, 6A23, 6A24, 6A2Y,6A2Z) or LCFT EIS psychosis criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States (CAARMS) 4. In contact with mental health services, and have an assigned care-coordinator 5. Within 3 years from psychosis onset 6. Judged by the assigned care-coordinator/responsible clinician as clinically stable (no treatment change in the previous month) 7. Reporting at least 1 traumatic event on the Trauma Screening Questionnaire (TSQ), and at least subsyndromal post-traumatic symptoms in the previous week (scores > 0 on items 3_1 to 3_5 of the TSQ) 8. Meet a criterion level of positive symptoms severity, indicated by a score > 3 (symptom present) on the delusions (P1), hallucinations (P3), grandiosity (P5) or suspiciousness (P6) items of the PANSS in the previous week

Exclusion criteria

Exclusion criteria: 1. Primary diagnosis of substance/alcohol dependence, intellectual disability or cognitive dysfunction, as provided by the participant care-coordinator/clinical team 2. Non-English speaking or requiring an interpreter for the intervention (the therapy and assessment battery at present can only be delivered in English) 3. Receipt of EMDR from a qualified psychological therapist in accordance with NICE guidelines for PTSD in the past 12 months

Design outcomes

Primary

Measure	Time frame
Feasibility assessed after completion of 6 and 12 months battery assessment follow-ups by calculating: 1. Recruitment rate: the number of participants consented into the trial and randomised 2. Therapy/assessment retention: % who drop-out of therapy 3. Therapy fidelity: % who did not receive treatment allocated 4. Adherence: ratings from therapy tapes 5. Therapy safety: number of Serious Adverse Events (SAEs)	—

Measure

Time frame

Feasibility assessed after completion of 6 and 12 months battery assessment follow-ups by calculating: 1. Recruitment rate: the number of participants consented into the trial and randomised 2. Therapy/assessment retention: % who drop-out of therapy 3. Therapy fidelity: % who did not receive treatment allocated 4. Adherence: ratings from therapy tapes 5. Therapy safety: number of Serious Adverse Events (SAEs)

—

Secondary

Measure	Time frame
Measured at baseline, 6 and 12 months: 1. Psychotic symptoms measured using: 1.1. The PANSS, the most widely-used research measure to assess the severity of positive and negative symptoms of psychosis as well as symptoms of general psychopathology 1.2. The Psychotic Symptoms Rating Scales, a semi-structured interview completed alongside the PANSS to provide a more fine-grained assessment of auditory hallucinations and delusions, including measures of subjective distress caused by these symptoms 1.3. The Green et al. Paranoid Thoughts Scale, a brief self-report questionnaire assessing paranoid thinking and persecutory delusions. 2. Trauma exposure and trauma-related difficulties, measured using: 2.1. The TSQ, a brief measure used to screen for trauma exposure and post-traumatic stress. In the present study, the modified version of the TSQ developed by de Bont and colleagues for use in people with psychosis will be used to check the participants’ potential eligibility in this trial 2.2. The Trauma and Life Events checklist (TALE), a measure specifically designed to assess exposure to adverse and traumatic life experiences that are commonly reported by people with psychosis 2.3. The PTSD Checklist for DSM-5, a self-report questionnaire assessing the presence and severity of post-traumatic symptoms. 2.4. The 12-item version of the International Trauma Questionnaire (ITQ), a brief measure assessing the severity of symptoms of PTSD and complex PTSD as defined in the recently published ICD-11. 2.5. The Dissociative Experiences Scale-II, a self-report measure of dissociation. 3. Health economic measures: 3.1. The EQ-5D-5L (Devlin et al., 2018; Jansen et al., 2013), a health status questionnaires used in health economics analyses. 3.2. An adapted version of the Economic	—

Measure

Time frame

Measured at baseline, 6 and 12 months: 1. Psychotic symptoms measured using: 1.1. The PANSS, the most widely-used research measure to assess the severity of positive and negative symptoms of psychosis as well as symptoms of general psychopathology 1.2. The Psychotic Symptoms Rating Scales, a semi-structured interview completed alongside the PANSS to provide a more fine-grained assessment of auditory hallucinations and delusions, including measures of subjective distress caused by these symptoms 1.3. The Green et al. Paranoid Thoughts Scale, a brief self-report questionnaire assessing paranoid thinking and persecutory delusions. 2. Trauma exposure and trauma-related difficulties, measured using: 2.1. The TSQ, a brief measure used to screen for trauma exposure and post-traumatic stress. In the present study, the modified version of the TSQ developed by de Bont and colleagues for use in people with psychosis will be used to check the participants’ potential eligibility in this trial 2.2. The Trauma and Life Events checklist (TALE), a measure specifically designed to assess exposure to adverse and traumatic life experiences that are commonly reported by people with psychosis 2.3. The PTSD Checklist for DSM-5, a self-report questionnaire assessing the presence and severity of post-traumatic symptoms. 2.4. The 12-item version of the International Trauma Questionnaire (ITQ), a brief measure assessing the severity of symptoms of PTSD and complex PTSD as defined in the recently published ICD-11. 2.5. The Dissociative Experiences Scale-II, a self-report measure of dissociation. 3. Health economic measures: 3.1. The EQ-5D-5L (Devlin et al., 2018; Jansen et al., 2013), a health status questionnaires used in health economics analyses. 3.2. An adapted version of the Economic

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026