Title: Reducing psychosis risk by targeting trauma (RESTART)
Funder: Department of Health and Social Care

Abstract: Trauma (e.g. childhood maltreatment) is a major risk factor for psychosis; epidemiological data suggests that targeting trauma could reduce psychosis incidence by 33%. We can now identify individuals at high risk of developing psychosis using clinical criteria known as At Risk Mental States (ARMS), but available therapies for preventing the onset of psychosis in people experiencing ARMS are not sufficiently effective. Between 54-90% of individuals experiencing ARMS have a history of trauma; trauma is associated with more severe prodromal symptoms and functional impairments in this group, leading to greater risk of transition to psychosis. It is not known if psychological therapies that are effective for trauma-related mental health problems could be used to improve clinical and functional outcomes in this group, hence representing innovative interventions for the prevention of psychosis. The project aims to: 1) Identify tractable trauma-related mechanisms associated with greater prodromal symptom severity and functional impairment in people experiencing ARMS; 2) Adapt the protocols of four therapies that ameliorate these trauma-related mechanisms and improve their acceptability to this target group; 3) Conduct a feasibility multi-arm trial evaluating the acceptability of these adapted therapies, and the feasibility of conducting a future multi-arm definitive trial. The research will involve three work-packages (WP) delivered over 45 months. WP1 will analyse additional data that will be collected from a subsample of ARMS participants (N = 150) from an ongoing NIHR-funded cohort study (HTA:17/31/05). Structural equation modelling will be used to identify key trauma-related mechanisms associated with functional impairment and more severe prodromal symptoms. WP2 will involve qualitative work and PPI (in depth-interviews with 12-20 ARMS individuals and 12-20 NHS staff; nominal consensus meetings with six 'experts by experience' and six 'experts by profession') to select, based on WP1 findings, the trauma therapies most suited to improving clinical and functional outcomes in this group and adapt them to the specific needs of people experiencing ARMS. WP3 will be a feasibility multi-arm randomised controlled trial with 100 ARMS participants allocated to TAU or the trauma therapies adapted in WP2. Participants will be followed up for 8 months using qualitative and quantitative assessments to evaluate treatment acceptability, the feasibility of conducting a future definitive multi-arm trial and the potential inclusion of adaptive procedures in a future definitive trial. My research will provide unique insight into the impact of trauma on people experiencing ARMS and identify important trauma intervention targets. It will deliver bespoke therapy protocols for improving trauma sequelae as well as prodromal symptoms and functional impairments associated with greater risk for transition to psychosis in people experiencing ARMS. These protocols will be clinically-relevant, valuable and acceptable to patients, accessible to frontline services and ready for service implementation following a definitive efficacy and cost-effectiveness evaluation. I will establish collaborations with international experts and centres of excellence in the treatment of ARMS. I will disseminate findings through tailored events for people with lived-experience of ARMS and other stakeholders as well as through publications in high-impact journals and presentations and workshops at international conferences.

Lay abstract: People who have experienced traumatic events (such as bullying, physical abuse, sexual abuse) have much higher chances of developing mental health problems, including 'psychosis'. Psychosis is a mental health problem that causes people to perceive or interpret things differently from those around them. This can involve distressing experiences, such as hearing voices or having unusual beliefs. In the UK, almost half a million people experience psychosis. Living with psychosis can be distressing for both the individual and their family as it can have an important impact on person's ability to carry out day-to-day activities such as going to work, studying and making friends. Doctors and nurses in the NHS already use special interviews that can identify people that have a high risk of developing psychosis. However, the treatments to prevent psychosis we can currently offer to these vulnerable people do not always work, possibly because they are not fine-tuned enough to what they really need. Past research has showed that 8 out of 10 people who are at high risk of developing psychosis have experienced traumatic events. If we could treat the psychological consequences of trauma early enough, we might be able to prevent psychosis from occurring and reduce the negative impact that psychosis would have on people's lives. I want to ensure that fewer people develop psychosis by offering better psychological therapies that specifically address trauma. I will work for 45 months with patients, NHS professionals and international experts to find out which psychological therapies could be most useful for improving the mental health of people who are at the highest risk of developing psychosis. First, I will ask 150 people who are at high risk of developing psychosis to fill out questionnaires on traumatic life experiences and psychological difficulties commonly linked with these experiences. I will use this information to better understand how trauma is linked to more severe mental health and day-to-day difficulties in this group, and which therapies could be most helpful. Second, I will interview in more detail people vulnerable to psychosis and the NHS professionals who work with them to understand how we should adapt existing psychological therapies for trauma to fit better their needs. I will use this information and the findings from the above questionnaires to adapt the content and format of four psychological therapies that have already been shown to be helpful to other trauma survivors. I will then ask a group of NHS professionals and people at high risk of developing psychosis to discuss their views on whether all these therapies should be selected for further research, or drop the therapies they think are unlikely to be helpful. Third, I will conduct a clinical trial with 100 people across several NHS services in the North West of England. The trial will find out if the therapies are safe, if people are able to attend therapy appointments and engage in them, and if they feel that they have benefited from them. We will also collect information to understand if these therapies could be used widely in the NHS, as part of larger-scale research that will ensure these therapies could be offered across the UK in the future.Throughout the project, I will work with people with lived experience of trauma and psychosis to create easy-to-understand summaries of the findings and identify ways by which I can share my findings widely with the public. I will also present the findings in scientific journals and at international conferences to influence future research and the care people at risk of developing psychosis receive both in the UK and across the globe.

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