Key Points Question Can a brief blended digital therapy targeting reasoning (SlowMo) improve paranoia for adults with psychosis when added to usual care? Findings This randomized clinical trial of 361 individuals with clinical paranoia did not demonstrate that SlowMo therapy reduced the primary outcome of self-reported paranoia at 24 weeks compared with usual care only, although secondary beneficial effects were found on this measure at 12 weeks. Self-reported persecution and observer-rated paranoia were improved at both points. Meaning SlowMo, a digitally supported reasoning intervention, indicated a beneficial effect on paranoia; further work to optimize the effects of SlowMo is warranted.

Background: The SlowMo study demonstrated the effects of SlowMo, an eight-session digitally supported reasoning intervention, on paranoia in a large-scale randomizedcontrolled trial with 362 participants with schizophrenia-spectrum psychosis.

BackgroundParanoia is one of the most common symptoms of schizophrenia-spectrum disorders, and is associated with significant distress and disruption to the person’s life. Developing more effective and accessible psychological interventions for paranoia is a clinical priority. Our research team has approached this challenge in two main ways: firstly, by adopting an interventionist causal approach to increase effectiveness and secondly, by incorporating user-centred inclusive design methods to enhance accessibility and usability. Our resultant new digital intervention, SlowMo, intensively targets a reasoning style associated with paranoia, fast thinking, characterised by jumping to conclusions and belief inflexibility. It consists of an easy-to-use, enjoyable and memorable digital interface. An interactive web-based app facilitates delivery of face-to-face meetings which is then synchronised with an innovative mobile app for use in daily life.Methods/DesignWe aim to test the clinical efficacy of SlowMo over 24 weeks to determine the mechanisms through which it reduces paranoia, and to identify participant characteristics that moderate its effectiveness. In a parallel-group randomised controlled trial, with 1:1 allocation, 360 participants with distressing persecutory beliefs will be independently randomised to receive either the SlowMo intervention added to treatment as usual (TAU) or TAU, using randomly varying permuted blocks, stratified by paranoia severity and site. Research workers will be blind to therapy allocation. The primary outcome is paranoia severity over 24 weeks; our hypothesised mechanism of change is reasoning; moderators include negative symptoms and working memory; and secondary outcomes include wellbeing, quality of life, and service use. The accessibility, usability and acceptability of the digital platform will be assessed.DiscussionSlowMo has been developed as the first blended digital therapy to target fears of harm from others through an inclusive design approach. In addition to testing its efficacy, this trial will add to our understanding of psychological mechanisms in paranoia. The study will examine the usability and adherence of a novel digital therapy, including an app for self-management, in a large sample of people affected by severe mental health difficulties.Trial registrationISRCTN registry, ID: ISRCTN32448671. Registered prospectively on 30 January 2017. Date assigned 2 February 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2242-7) contains supplementary material, which is available to authorized users.

Objectives SlowMo is the first blended digital therapy for paranoia, showing significant small‐moderate reductions in paranoia in a recent large‐scale randomized controlled trial (RCT). This study explored the subjective service‐user experience of the SlowMo therapy content and design; the experience of the blended therapy approach, including the triangle of the therapeutic alliance; and the experience of the digital aspects of the intervention. Design Qualitative co‐produced sub‐study of an RCT. Methods Participants were 22 adult service users with schizophrenia‐spectrum psychosis and persistent distressing paranoia, who completed at least one SlowMo therapy session and a 24‐week follow‐up, at one of 3 sites in Oxford, London, and Sussex, UK. They were interviewed by peer researchers, using a topic guide co‐produced by the Patient and Public Involvement (PPI) team. The transcribed data were analysed thematically. Multiple coding and triangulation, and lay peer researcher validation were used to reach a consensus on the final theme structure. Results Six core themes were identified: (i) starting the SlowMo journey; (ii) the central role of the supportive therapist; (iii) slowing things down; (iv) value and learning from social connections; (v) approaches and challenges of technology; and (vi) improvements in paranoia and well‐being. Conclusions For these service users, slowing down for a moment was helpful, and integrated into thinking over time. Learning from social connections reflected reduced isolation, and enhanced learning through videos, vignettes, and peers. The central role of the supportive therapist and the triangle of alliance between service user, therapist, and digital platform were effective in promoting positive therapeutic outcomes.

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