STOP- Successful Treatment Of Paranoia: Replacing harmful paranoid thoughts with better alternatives

Paranoia is linked to several mental health conditions, including psychosis and leads to distress and impairment in work, family and social functioning. Recent advances in thinking suggest that treatments might be more effective if they focus on one particular symptom at a time and try to treat that rather than trying to treat the whole disorder in one go. This study proposes to develop and test a mobile app version of a new therapy for paranoia called CBM-pa. CBM-pa is a self-administered psychological therapy that has been developed by combining basic research on biases in paranoia with established techniques that can change these biases. CBM-pa is computerised and involves reading text that could be interpreted in a paranoid way (such as the stare of a stranger which could reflect harmful intentions). The therapy encourages readers to make the alternative interpretation (such as the stare reflecting harmless curiosity) by using word tasks and questions. A six-session version has been developed and a feasibility study has been completed with promising results. In year 1 of this study we will develop CBM-pa into a more accessible and engaging 12- session app for mobile phones, called STOP: Successful Treatment of Paranoia, by adding 6 newly created sessions. In years 2-4 we will give patients STOP alongside their usual treatment and compare this with a control condition where patients simply read text in the mobile app instead. The study uses a randomised controlled design and patients are recruited from two different UK sites. Participants will receive either 6 or 12 sessions of STOP and we will measure clinical symptoms immediately and at 3 and 6 months later. These treatment data will be compared with data from similar people who take part in a control condition (reading text in the app) and are assessed at the same times. The data will show us whether there are any beneficial effects of STOP and, if so, how long they last. We will also measure in more detail exactly how many sessions produce enough symptom reduction to be clinically useful.

Paranoia is associated with a range of mental health conditions, including psychosis. The lifetime rate of psychotic disorders is 3.5%. Psychosis is one of the most disabling mental health conditions, associated with distress and impairment in work, family and social functioning. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms.This study proposes to develop and test the efficacy of an app version (STOP) of a novel intervetion for paranoia (CBM-pa). CBM-pa is a self-administered psychological procedure that has been developed by combining basic research on biases in paranoia with established CBM techniques. CBM-pa is computerised and involves reading text inviting paranoid interpretations, but then generating responses reflecting an alternative, non-paranoid interpretation. A six session version has been developed and a feasibility study has been completed with promising results. In this proposal (year 1) we will develop CBM-pa into a more accessible and engaging 12 session 'STOP' app for mobile phones, adding 6 newly created sessions. We will then (years 2-4) deliver STOP in addition to treatment as usual and compare it with a text reading control condition, conducting app-based outcome assessments after every session. As suggested in previous feedback, we now propose a 2 arm dose-finding study using a randomised controlled design conducted across two sites. Retrospective time series analysis will establish the minimum number of sessions required to achieve clinically significant reduction of paranoid symptoms. To add value at minimal cost, and to provide data required by potential investors, we will include a 3 and 6 month follow up to assess long term efficacy of 12 sessions. This design will establish both the minimum immediately effective dose of STOP plus the long term efficacy of 12 sessions when this promising intervention is delivered in a form suitable for widespread patient/public use.