Overcoming persecutory delusions.

Background: Persecutory delusions occur in over 70% of patients with schizophrenia. This major psychotic experience is a key treatment target. The delusion has substantial impact for patients (and families), including suicidal ideation, isolation, and hospital admission. Schizophrenia is among the top ten disorders in terms of burden of illness, disability and societal and health costs worldwide. The total annual cost to the public sector in England is over £7 billion. Life expectancy is 15-20 years shorter for people with these problems. Approximately half of patients do not respond adequately to the first line treatment, medication. Residual problems are very common. Examining care provision, the Schizophrenia Commission (2012) concluded: 'What we found was a broken and demoralised system that does not deliver the quality of treatment that is needed for people to recover. This is clearly unacceptable in England in the 21st century.' The 2014 National Audit of Schizophrenia calls for NHS Trusts to increase access to evidence-based psychological interventions. But trials show that the psychological treatment needs improvement. It leads to recovery in only 10% of medication-resistant delusions. A much more efficacious, easily useable intervention is urgently required. The applicant has developed a rigorously tested theoretical model of persecutory delusions. At the core of the delusion is a belief of being unsafe, developed in the context of genetic and environmental risk, that is maintained by a number of factors including disrupted sleep, worrying, negative beliefs about the self, reasoning biases, and avoidance of others. The delusion diminishes if maintaining factors are successfully reduced and the patient is then enabled to relearn that they are safe. The applicant has been developing brief intervention modules each targeting a maintaining factor. One by one the modules have been successfully evaluated. These modules need to be tested together as a full treatment (16-20 sessions). A case series with 12 patients is already indicating the potential major benefits of the full treatment (The Feeling Safe Programme). Aims: The target is recovery in medication-resistant delusions for 50% of patients. The key question asked is: Does the Feeling Safe Programme lead to greater recovery in persecutory delusions, psychological well-being, and activity levels compared to an attention control condition (befriending)? The second aim is to ready the intervention for widespread NHS implementation. Plan of investigation: The main study is a randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment i.e. the group most at need. Patients will be randomised to the Feeling Safe Programme or an attention control condition (thus controlling for non-specific benefits of contact). Medication prescription will continue as usual. Blind assessments will be conducted at 0, 6 (post treatment), and 12 months. All main analyses will be intention-to-treat. A health economic evaluation is included. The study will be embedded into psychosis services in Oxford Health NHS Foundation Trust, providing a case study for implementation. Qualitative interviews will be carried out with patients, carers, and NHS staff to determine views of the intervention and implementation. The treatment is highly likely to have wider applicability in schizophrenia treatment. Therefore a scoping exercise will be carried out with a cohort of 200 patients with early psychosis in the Thames Valley region. Potential benefits to patients and the NHS: It is anticipated that the research professorship will provide a highly efficacious intervention for one of the key problems of severe mental disorder: persecutory delusions. It will be the world's main psychological treatment package for persecutory delusions. The intervention will be highly manualised, and will demystify delusions, so that mental health professionals are able to incorporate it into routine care. A dissemination package will be produced.