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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial

Authors: Philippa A. Garety, Thomas Ward, Daniel Freeman, David Fowler, Richard Emsley, Graham Dunn, Elizabeth Kuipers, Paul Bebbington, Helen Waller, Kathryn Greenwood, Mar Rus-Calafell, Alison McGourty, Amy Hardy

Published in: Trials | Issue 1/2017

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Abstract

Background

Paranoia 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/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.

Trial registration

ISRCTN registry, ID: ISRCTN32448671. Registered prospectively on 30 January 2017. Date assigned 2 February 2017.
Appendix
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Metadata
Title
SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial
Authors
Philippa A. Garety
Thomas Ward
Daniel Freeman
David Fowler
Richard Emsley
Graham Dunn
Elizabeth Kuipers
Paul Bebbington
Helen Waller
Kathryn Greenwood
Mar Rus-Calafell
Alison McGourty
Amy Hardy
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2242-7

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