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SlowMo, a digital therapy targetingreasoning in paranoia, versus treatment asusual in the treatment of people who fearharm from others: study protocol for arandomised controlled trial

Garety, PA; Ward, T; Freeman, D; Fowler, D; Emsley, R; Dunn, G; Kuipers, E; ... Hardy, H; + view all (2017) SlowMo, a digital therapy targetingreasoning in paranoia, versus treatment asusual in the treatment of people who fearharm from others: study protocol for arandomised controlled trial. Trials , 18 (510) pp. 1-13. 10.1186/s13063-017-2242-7. Green open access

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Abstract

Background:Paranoia is one of the most common symptoms of schizophrenia-spectrum disorders, and isassociated with significant distress and disruption to the person’s life. Developing more effective andaccessible psychological interventions for paranoia is a clinical priority. Our research team has approachedthis challenge in two main ways: firstly, by adopting aninterventionist causal approachto increase effectiveness andsecondly, by incorporatinguser-centred inclusive design methodsto enhance accessibility and usability. Our resultantnew 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/Design:We 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. Discussion: SlowMo 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.

Type: Article
Title: SlowMo, a digital therapy targetingreasoning in paranoia, versus treatment asusual in the treatment of people who fearharm from others: study protocol for arandomised controlled trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-017-2242-7
Publisher version: http://doi.org/10.1001/jama.2016.445410.1186/s1306...
Language: English
Additional information: Copyright © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Delusions, persecutory, Fast and slow thinking, Belief flexibility, Jumping to conclusions, mHealth, eHealth, Digital therapy, User-centred design
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > IoN RLW Inst of Neurological Sci
URI: https://discovery.ucl.ac.uk/id/eprint/10028128
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