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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital ‘informed choice’ intervention to improve attitudes towards uptake and implementation of CBT for psychosis

Authors: Kathryn Greenwood, Katie Alford, Iain O’Leary, Emmanuelle Peters, Amy Hardy, Kate Cavanagh, Andy P. Field, Richard de Visser, David Fowler, Matthew Davies, Alexandra Papamichail, Philippa Garety

Published in: Trials | Issue 1/2018

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Abstract

Background

At least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment. Cognitive behaviour therapy for psychosis (CBTp) is the only NICE-recommended individual therapy for psychosis, with effects on symptoms, distress and quality of life. Yet <10% of service-users receive it and 94% of trusts struggle to provide it. Of those offered it, 22–43% refuse or do not attend. We have developed a new pre-CBTp informed choice intervention to address knowledge and attitudes that influence uptake and implementation and now want to test it in a feasibility trial.

Methods

The design is a two-arm, feasibility randomised controlled trial (RCT), with 1:1 randomisation, stratified by participant group and site. Participants are 40 psychosis patients and 40 clinicians, who are ambivalent towards uptake or implementation of CBTp. Sites are community and inpatient services in Sussex and London. The intervention is a pre-CBT digital psychoeducation intervention designed to address identified knowledge and attitudinal barriers to uptake and implementation of CBTp, incorporating behaviour change mechanisms, and supported by animated introductory, patient and clinician stories. The comparator is the NHS choices website for CBT. The primary aim is to assess clinical feasibility (recruitment, randomisation, acceptability, use, delivery, outcome measurement, retention). A secondary aim is a preliminary evaluation of efficacy. Outcomes will be assessed at baseline, post intervention, and one-month follow-up (blind to treatment arm). The primary efficacy outcome is likelihood of offering/taking up CBTp. Secondary outcomes include knowledge and attitudes towards CBTp, illness perceptions, empowerment, psychological wellbeing (patients only) and CBTp implementation (clinicians only). Use of the intervention and CBT behaviours during the follow-up period will be recorded and captured in a feedback questionnaire. Use, acceptability and experience of outcome assessment will be explored in qualitative interviews with participants (n = 6 per group). The efficacy evaluation will report descriptive data, key model parameters and 95% highest probability density intervals in a Bayesian growth model.

Discussion

This is the first feasibility trial of a digital ‘informed choice’ decision aid for the implementation of CBTp. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted.

Trial registration

ISRCTN registry, ISRCTN53107879. Registered prospectively on 2 August 2017.
Appendix
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Metadata
Title
The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital ‘informed choice’ intervention to improve attitudes towards uptake and implementation of CBT for psychosis
Authors
Kathryn Greenwood
Katie Alford
Iain O’Leary
Emmanuelle Peters
Amy Hardy
Kate Cavanagh
Andy P. Field
Richard de Visser
David Fowler
Matthew Davies
Alexandra Papamichail
Philippa Garety
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3023-7

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