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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2)

Authors: Mark Hayward, Clio Berry, Ben Cameron, Kate Arnold, Katherine Berry, Stephen Bremner, Kate Cavanagh, David Fowler, Heather Gage, Kathryn Greenwood, Cassie Hazell, Anna-Marie Jones, Sam Robertson, Clara Strauss

Published in: Trials | Issue 1/2020

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Abstract

Background

The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that maintain distress. We have developed a brief form of CBTp for distressing voices and reported preliminary evidence for its effectiveness when delivered by highly trained therapists (clinical psychologists). This study will investigate the delivery of this intervention by a cost-effective workforce of assistant psychologists following a brief training and evaluate the acceptability and feasibility of conducting a future, definitive, randomised controlled trial (RCT).

Methods

This is a feasibility study for a pragmatic, three-arm, parallel-group, superiority 1:1:1 RCT comparing a Guided self-help CBT intervention for voices and treatment as usual (GiVE) to Supportive Counselling and treatment as usual (SC) to treatment as usual alone (TAU), recruiting across two sites, with blinded post-treatment and follow-up assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience.

Discussion

Expected outcomes will include an assessment of the feasibility of conducting a definitive RCT, and data to inform the calculation of its sample size. If evidence from a subsequent, fully powered RCT suggests that GiVE is clinically and cost-effective when delivered by briefly trained assistant psychologists, CBTp offered in these less resource-intensive forms has the potential to generate benefits for individual patients (reduced distress, enhanced recovery and enhanced quality of life), service-level patient benefit (increased access to evidence-based psychological therapies) and economic benefits to the NHS (in terms of the reduced use of mental health inpatient services).

Trial registration

Current Controlled Trials, ISRCTN registration number: 16166070. Registered on 5 February 2019.
Appendix
Available only for authorised users
Footnotes
1
This assessment will only be offered to participants who reach the 28 weeks’ post-randomization milestone before the end of the data collection period.
 
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Metadata
Title
Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2)
Authors
Mark Hayward
Clio Berry
Ben Cameron
Kate Arnold
Katherine Berry
Stephen Bremner
Kate Cavanagh
David Fowler
Heather Gage
Kathryn Greenwood
Cassie Hazell
Anna-Marie Jones
Sam Robertson
Clara Strauss
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4181-y

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