Title: Preventing psychosis in young people at ultra-high-risk attending NHS mental health services: a feasibility study of a novel intervention target.
Funder: Department of Health and Social Care

Abstract: Background Psychosis is a severe mental health problem that can have many substantial, negative, and long-term consequences for individuals, families, and society. Prevention of such mental health conditions is a key NHS priority. There is an important group of young people in contact with NHS mental health services, with subthreshold psychotic symptoms and impaired functioning, who are identified as being at ultra-high-risk of developing psychosis. Recent scientific research has identified sleep disturbance as a key predictor, and potential contributory causal factor, for patients at ultra-high-risk to transition to having a psychotic disorder such as schizophrenia. We have developed an intervention to treat sleep disturbance in order to reduce the proportion of these patients who go on to develop psychosis. Our pilot work (a published case series of outcomes and a published qualitative study of the experience of the therapy) indicates this approach is highly valued by young people and the treatment techniques are likely to be effective. The primary goal is to reduce, by treating the sleep disturbance, the number of young patients at ultra-high-risk who develop psychosis. That has never been tested. Aim This feasibility study aims to establish the necessary key parameters for a definitive trial to determine the clinical effects of the (brief) targeted sleep intervention for young people attending mental health services who are at ultra-high-risk of developing psychosis. Method A prospective randomised controlled feasibility trial will be conducted. Forty patients aged 14-25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from NHS mental health services. Participants will be randomised to receive a novel, targeted, youth-focused sleep intervention in addition to usual care or usual care alone. Blinded assessments will be conducted at baseline, three months (post-intervention) and nine months (follow-up). The intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants views on the acceptability of study procedures, 16 participants (n=10 active, n=6 control) will take part in a qualitative study. Specific progression criteria for a definitive trial (for example, recruitment and retention rates, acceptability of wearable-tech devices) have been identified. Timeline The study will be conducted over 27 months with a recruitment period of 14 months. Presuming the progression criteria are met, the final phase of the study will include submission of a grant proposal for a phase-III trial to the NIHR HTA programme (early 2022). Anticipated impact and dissemination This will be the first randomised controlled test of an intervention for sleep disturbance in young patients at ultra-high-risk of psychosis. Mechanisms are already in place for rapid dissemination of the treatment if it proves beneficial: the intervention would be embedded within current NHS England training initiatives for the provision of psychological treatments in early psychosis services.

Lay abstract: Aim We aim to reduce the number of young people who develop psychosis. New evidence has shown that poor sleep is a causal factor in the development of severe mental health problems, including psychosis. We want to show that successfully treating sleep problems in young people, who are at the highest risk of developing psychosis and attend NHS services, helps to prevent the onset of psychosis. Why is the research important? In the UK there are an estimated 320,000 young people aged 15-24 at high risk of psychosis. NHS mental health services see those who are at the highest risk. Around 20% of these help-seeking young people will go on to develop psychosis within 12 months. The development of psychosis has multiple major consequences on psychological wellbeing, physical health, relationships, education, and employment. We would like fewer young people to develop psychosis. As disrupted sleep has proven to be a major causal factor, we have developed a psychological sleep treatment. This has been tested in a small study with 12 young people. The results are highly promising and we would like to carry out a much larger study to test if the sleep treatment works. In order to do this, a preparatory trial is needed to test the study procedures and develop the treatment further. What will happen in the study? Forty young people, who are at the highest risk of developing psychosis, will be invited to take part in the study. Half of the group will receive the sleep treatment and the other half will continue with their usual treatment. The young people will complete assessments at 0 months (before treatment), 3 months (after the treatment period), and 9 months (follow-up). Taking part in the study is voluntary. Before deciding whether to participate, we will explain the study and answer any questions. How will results be measured? We will look at how many young people we recruit to take part, how successful we were at collecting data, and how many young people completed the treatment. We will measure the young people s sleep, psychotic experiences, wellbeing, and activity levels. We will interview the young people to find out how acceptable the sleep treatment and study was for them. How could this study benefit patients in the future? The sleep treatment will only be given in NHS services if it is shown to reduce the development of psychosis. We want to provide this evidence. NHS England trains staff in the delivery of psychological interventions for psychosis. If successful, our approach could be introduced into this training and used within the NHS. We hope this would mean fewer young people will develop psychosis.

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