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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial

Authors: Jenny Yiend, Antonella Trotta, Christopher Meek, Ilvana Dzafic, Nora Baldus, Bryony Crane, Thomas Kabir, Daniel Stahl, Margaret Heslin, Sukhwinder Shergill, Philip McGuire, Emmanuelle Peters

Published in: Trials | Issue 1/2017

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Abstract

Background

Persecutory delusions are the most common type of delusions in psychosis and present in around 10–15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in order to reduce paranoia in patients.

Methods

The ‘Cognitive Bias Modification for paranoia’ (CBM-pa) study is a feasibility, double-blind, randomised controlled trial (RCT) for 60 stabilised outpatients with persistent, distressing paranoid symptoms. Patients will be randomised at a 50:50 ratio, to computerised CBM-pa or a text-reading control intervention, receiving one 40-min session per week, for 6 weeks. CBM-pa involves participants reading stories on a computer screen, completing missing words and answering questions about each story in a way that encourages more helpful beliefs about themselves and others. Treatment as Usual will continue for patients in both groups. Patients will be assessed by a researcher blind to allocation, at baseline, each interim session, post treatment and 1- and 3-month follow-up post treatment. The primary outcome is the feasibility parameters (trial design, recruitment rate and acceptability) of the intervention. The secondary outcomes are clinical symptoms (including severity of paranoia) as assessed by a clinical psychologist, and ‘on-line’ measurement of interpretation bias and stress/distress. The trial is funded by the NHS National Institute for Health Research.

Discussion

This pilot study will test whether CBM-pa has the potential to be a cost-effective, accessible and flexible treatment. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a fully powered RCT will be warranted.

Trial registration

Current Controlled Trials ISRCTN:​ 90749868. Retrospectively registered on 12 May 2016.
Appendix
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Metadata
Title
Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial
Authors
Jenny Yiend
Antonella Trotta
Christopher Meek
Ilvana Dzafic
Nora Baldus
Bryony Crane
Thomas Kabir
Daniel Stahl
Margaret Heslin
Sukhwinder Shergill
Philip McGuire
Emmanuelle Peters
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2037-x

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