Evidence map›Paper›PMID 29096681›Full record

Trial reportTrials2017

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.

Philippa A Garety, Thomas Ward, Daniel Freeman, David Fowler, Richard Emsley, Graham Dunn, Elizabeth Kuipers, Paul Bebbington, Helen Waller, Kathryn Greenwood and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  10. The revised GreenPsychological medicine · 2021
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  18. Developmental Aspects of Schizotypy and Suspiciousness: a Review.Current behavioral neuroscience reports · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Philippa A GaretyDepartment of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, P077 Henry Wellcome Building, De Crespigny Park, London, SE5 8AF, UK. philippa.garety@kcl.ac.uk.
Thomas WardDepartment of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, P077 Henry Wellcome Building, De Crespigny Park, London, SE5 8AF, UK.ORCID http://orcid.org/0000-0002-7608-5755
Daniel FreemanDepartment of Psychiatry, Oxford University, Oxford, UK.
David FowlerSchool of Psychology, University of Sussex, Brighton, UK.
Richard EmsleyCentre for Biostatistics, School of Health Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Graham DunnCentre for Biostatistics, School of Health Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Elizabeth KuipersDepartment of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, P077 Henry Wellcome Building, De Crespigny Park, London, SE5 8AF, UK.
Paul BebbingtonDivision of Psychiatry, University College London, London, UK.
Helen WallerDepartment of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, P077 Henry Wellcome Building, De Crespigny Park, London, SE5 8AF, UK.
Kathryn GreenwoodSchool of Psychology, University of Sussex, Brighton, UK.
Mar Rus-CalafellDepartment of Psychiatry, Oxford University, Oxford, UK.
Alison McGourtySussex Partnership NHS Foundation Trust, Worthing, UK.
Amy HardyDepartment of Psychology, King's College London, Institute of Psychiatry, Psychology and Neuroscience, P077 Henry Wellcome Building, De Crespigny Park, London, SE5 8AF, UK.

Funding

Department of Health EME/15/48/21Department of Health RP-2014-05-003
6 · The paper itself

Abstract

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. 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 registrationISRCTN registry, ID: ISRCTN32448671 . Registered prospectively on 30 January 2017. Date assigned 2 February 2017.

Indexed as

FearMental HealthThinkingCell PhoneClinical ProtocolsEnglandHumansInternetMobile ApplicationsParanoid DisordersPsychotherapyQuality of LifeRemote ConsultationResearch DesignTherapy, Computer-AssistedTime FactorsBelief flexibilityDelusionsDigital therapyeHealthFast and slow thinkingJumping to conclusionsmHealthPersecutoryUser-centred design

Identifiers

PMID29096681
PMCPMC5667466

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.