A quarter of a million people in the UK with severe paranoia could swap months of waiting for a therapist for a guided app on their phone. Persecutory delusions—the fixed, terrifying belief that others intend you harm—are among the most disabling symptoms of psychosis. Current treatments help only some patients, and access to specialist cognitive behavioural therapy is limited by long waiting lists and a shortage of trained therapists. The Feeling Safe programme, developed by the researchers, has already shown strong results in trials. This project will turn that 30-booklet therapy into a guided app that can be delivered by peer-support workers or graduate mental health workers, not just by CBT therapists. If it works, the NHS could treat far more patients without needing to expand its specialist workforce. A randomised trial with 484 patients will test whether the app is effective when supported by three different staff groups, and a health economic analysis will show whether it saves money. The goal is a NICE-recommended digital therapy that cuts paranoia and improves wellbeing for a large, underserved patient population.
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Background: Persecutory delusions are one of the most severe mental health problems. We have developed a highly effective, theoretically driven cognitive therapy (the Feeling Safe programme) for patients experiencing persecutory delusions in the context of a diagnosis of psychosis. Feeling Safe arguably constitutes one of the most significant improvements in the treatment of severe mental health problems in the past three decades. Aim: By providing Feeling Safe in an accessible version for use across the NHS, we aim to achieve substantially improved outcomes for the large number of people with persecutory delusions who have not responded sufficiently to current treatment. Objectives: 1. Develop an effective, engaging guided app version of Feeling Safe that: i. reduces NHS staff time to deliver; ii. greatly widens the range of staff that can support it; iii. can be used by a diverse patient population. 2. Show that the guided app treatment is highly effective for patients and can be successfully delivered by three mental health staff groups: peer-support workers, graduate mental health workers including assistant psychologists, and CBT therapists. If the programme is only effective with CBT therapists, this will widen access by reducing the time needed. If the programme is also effective with other staff groups, this will widen access by enabling a larger workforce to deliver it. We will also ensure the therapy is effective across gender, age, ethnicity, and cognitive abilities. 3. Conduct a full health economic evaluation of the guided app treatment. 4. Support implementation by: i. developing an implementation toolkit; ii. providing the information necessary to support a NICE Medical Technologies Guidance recommendation; iii. meeting the NICE Evidence Standards Framework for Digital Health Technologies. This will enable adoption by AHSN regional digital health accelerators, the NHS Accelerated Access Collaborative, and individual trusts. Methods: Throughout we will collaborate with people with lived experience. 1. The programme will be developed by following a user-centred double diamond design process, involving people with lived experience, the therapy developers, staff groups, software developers, and writers. The 30 booklets of the original Feeling Safe programme will form the starting point. Fifteen patients will take part in an iterative usability testing phase and fifteen patients in a case series test. 2. Efficacy will be tested in a multi-centre four-arm randomised controlled trial. 484 patients will be randomised to one of four conditions: the guided internet treatment (added to TAU) supported by peer support workers, or graduate mental health workers, or CBT therapists, or TAU. Feeling Safe will be provided for 6 months. Assessments will be conducted at 0, 6, and 9 months. 3. We will conduct a within-trial cost-effectiveness analysis and budget impact analysis. 4. The toolkit contents will be informed by the NASSS implementation framework, literature review, patient and stakeholder interviews, and health economics. Timelines: 0-18mths: development, programming, and initial testing; 18-46mths: clinical trial; 46-48mths: final reports. Anticipated impact: Patients in secondary care with severe mental health problems will have access to a powerful psychological therapy that will substantially reduce paranoia and increase psychological wellbeing.
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