Title: Eye Movement Desensitisation and Reprocessing therapy in early psychosis: A feasibility randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Adverse life experiences and post-traumatic stress are common in people with psychosis, in particular those with first episode psychosis. However, in routine clinical practice for this group the impact of previous traumas is largely not treated or otherwise addressed. Trauma increases the risk of developing psychosis, and dramatically aggravates the severity of psychosis in those receiving support from mental health services. Randomised controlled trials indicate that generic trauma-focused interventions designed for use in post-traumatic stress disorder (PTSD) are safe and acceptable in people with psychosis, but (despite initial encouraging findings) it remains unclear whether trauma-focused interventions can lead to lasting improvements in psychotic symptoms. Consistent with calls for the development of more specific interventions for the treatment of trauma in people with psychosis, clinicians within Lancashire Care NHS Foundation Trust (LCFT) have adapted a generic trauma-focused intervention known as Eye Movement Desensitisation and Reprocessing (EMDR), and developed an intervention protocol specifically suited to the treatment of trauma in those with early psychosis. This aims to ameliorate not only post-traumatic symptoms (which can already be achieved using generic trauma-focused therapies) but, more importantly, intrusive and distressing psychotic symptoms such as persecutory delusions and auditory hallucinations. Aims We aim to test the feasibility of running a randomised controlled trial (RCT) evaluating the efficacy and cost-effectiveness of a new intervention. This research aims to resolve several feasibility uncertainties that will inform a future definitive trial, including: 1) The acceptability of the measures; 2) Estimation of recruitment and retention; 3) Estimation of the variance of the proposed primary and secondary outcomes to inform sample size calculations; 4) Examination of service user views on the acceptability and impact of the intervention; 5) Exploration of stakeholders views of the facilitators, barriers and solutions for the implementation of a definitive trial of EMDR for psychosis. Plan of Investigation Sixty participants will be recruited from LCFT mental health teams. Eligible participants will 1) have a diagnosis of psychotic illness (within 3 years from the onset of psychosis), 2) report current distressing psychotic symptoms and at least sub-syndromal levels of trauma-related symptoms. Participants will be randomly allocated to receive up to 16 sessions of EMDR for psychosis over a six-month period and treatment as usual (TAU, i.e. case management and access to routine NICE-recommended psychosocial interventions) or TAU alone. Measures considering relevant outcomes (psychosis, trauma-related symptoms and a range of recovery, well-being and functioning measures) will administered by trained research assistants blind to treatment allocation on 3 occasions: baseline, at six-months and 12-months post-randomisation.Careful recording of recruitment, retention and acceptability parameters will take place throughout the project as per the modified CONSORT feasibility criteria. Furthermore, two qualitative studies within the RCT will: 1) Evaluate the acceptability of EMDR for psychosis as well as gaining insights into the experience of participating in the trial with a sub-sample of participants (n = 20). 2) Explore stakeholders (relevant mental health staff ; n = 20) views on the barriers to implementation of the definitive trial, as well as possible solutions. Potential Benefits Results will inform the design of the future multi-centre definitive RCT to evaluate the efficacy of EMDR as a suitable treatment for psychosis in people who have been affected by psychological traumas. In the short-term, the study will provide access to a potentially beneficial treatment for this client group, and should its efficacy be confirmed in the future large-scale evaluation, this would have a substantial impact in alleviating the suffering caused by psychosis, and relieve the considerable societal and personal burden caused by this condition.

Lay abstract: Psychosis (a term used to describe unusual experiences such as having strange distressing beliefs and hearing frightening voices) is a major cause of disability and suffering in the UK and worldwide. Traumatic experiences (for example sexual, physical or emotional abuse) are common in people with psychosis. These experience increase the risk of developing psychosis later in life, and people who have had complex traumatic life events generally suffer from more intense and distressing symptoms of psychosis. Eye Movement Desensitisation and Reprocessing (EMDR) is a talking therapy that helps people to improve mental health difficulties brought about by trauma. In recent research carried out in the Netherlands, people with psychosis found EMDR helpful for improving problems caused by trauma (e.g. unwanted distressing memories of the trauma), but we do not know yet if EMDR can also benefit symptoms of psychosis directly. We want to conduct a large study to see whether a modified version of EMDR (developed by NHS clinicians in Lancashire to work specifically with people with psychosis) can improve distressing psychotic symptoms. First, however, we need to find out if such a study will be viable and well-received by patients. Therefore, we will first conduct a small study with 60 people who have a history of trauma and who have developed psychosis for the first time within the previous three years. They will either receive 16 sessions of EMDR (in addition to their usual care) or their usual care only, and they will be interviewed multiple times about their symptoms and treatment experiences over a 12-month period. We will also work with NHS staff and service users groups to confirm the best way to engage services and patients, and plan the best ways to ensure that EMDR for psychosis is put into future NHS practice.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH