Trials (Sep 2023)

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3)

  • Mark Hayward,
  • Katherine Berry,
  • Stephen Bremner,
  • Kate Cavanagh,
  • Guy Dodgson,
  • David Fowler,
  • Heather Gage,
  • Kathryn Greenwood,
  • Cassie Hazell,
  • Anna-Marie Bibby-Jones,
  • Sam Robertson,
  • Morro Touray,
  • Natalie Dailey,
  • Clara Strauss

DOI
https://doi.org/10.1186/s13063-023-07611-7
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 15

Abstract

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Abstract Background The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. Methods This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. Discussion If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK’s National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. Trial registration Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

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