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Background Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users. Methods A single-blind RCT comparing 16 sessions of EMDRp + TAU v. TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomization assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the 'promise of efficacy' of EMDRp on relevant clinical outcomes. Results Sixty participants (100% of the recruitment target) received TAU or EMDR + TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp + TAU participants received at least eight therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp + TAU v. TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety, and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status. Conclusions The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-center trial of EMDRp is feasible and warranted.

Background Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users. Methods A single-blind RCT comparing 16 sessions of EMDRp + TAU vs TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomisation assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the ‘promise of efficacy’ of EMDRp on relevant clinical outcomes. Results 60 participants (100% of the recruitment target) received TAU or EMDR+TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp+TAU participants received at least 8 therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp+TAU vs TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status. Conclusions The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-centre trial of EMDRp is feasible and warranted.

Aim: Traumatic events are involved in the development and maintenance of psychotic symptoms. There are few trials exploring trauma-focused treatments as interventions for psychotic symptoms, especially in individuals with early psychosis. This trial will evaluate the feasibility and acceptability of conducting a definitive trial of Eye Movement Desensitisation and Reprocessing for psychosis (EMDRp) in people with early psychosis. Methods: 60 participants with first episode psychosis and a history of a traumatic/adverse life event(s) will be recruited from early intervention services in the North West of England and randomised to receive 16 sessions of EMDRp + Treatment as Usual (TAU) or TAU alone. Participants will be assessed at baseline, 6 months and 12 months post-randomisation using several measures of psychotic symptoms, trauma symptoms, anxiety, depression, functioning, service-user defined recovery, health economics indicators and quality of life. Two nested qualitative studies to assess participant feedback of therapy and views of professional stakeholders on the implementation of EMDRp into services will also be conducted. The feasibility of a future definitive efficacy and cost effectiveness evaluation of EMDRp will be tested against several outcomes, including ability to recruit and randomise participants, trial retention at 6- and 12-month follow-up assessments, treatment engagement and treatment fidelity. Conclusions: If it is feasible to deliver a multi-site trial of this intervention, it will be possible to evaluate whether EMDRp represents a beneficial treatment to augment existing evidence-based care of individuals with early psychosis supported by early intervention services.

Aim: Traumatic events are involved in the development and maintenance of psychotic symptoms. There are few trials exploring trauma-focused treatments as interventions for psychotic symptoms, especially in individuals with early psychosis. This trial will evaluate the feasibility and acceptability of conducting a definitive trial of Eye Movement Desensitisation and Reprocessing for psychosis (EMDRp) in people with early psychosis. Methods: 60 participants with first episode psychosis and a history of a traumatic/adverse life event(s) will be recruited from early intervention services in the North West of England and randomised to receive 16 sessions of EMDRp + Treatment as Usual (TAU) or TAU alone. Participants will be assessed at baseline, 6 months and 12 months post-randomisation using several measures of psychotic symptoms, trauma symptoms, anxiety, depression, functioning, service-user defined recovery, health economics indicators and quality of life. Two nested qualitative studies to assess participant feedback of therapy and views of professional stakeholders on the implementation of EMDRp into services will also be conducted. The feasibility of a future definitive efficacy and cost effectiveness evaluation of EMDRp will be tested against several outcomes, including ability to recruit and randomise participants, trial retention at 6- and 12-month follow-up assessments, treatment engagement and treatment fidelity. Conclusions: If it is feasible to deliver a multi-site trial of this intervention, it will be possible to evaluate whether EMDRp represents a beneficial treatment to augment existing evidence-based care of individuals with early psychosis supported by early intervention services.