Increasing access to CBT for psychosis patients: a randomized controlled trial evaluating brief, targeted CBT for distressing voices delivered by Assistant Psychologists
Trial acronym: GiVE3
Description
Psychosis is a severe form of mental health condition. People with a diagnosis of psychosis may experience distress associated with delusional beliefs and hearing voices. The National Institute for Health & Care Excellence (NICE) recommend Cognitive Behaviour Therapy for psychosis (CBTp) as one of the best treatments for people with a diagnosis of psychosis. But only 26% of people with a diagnosis of psychosis have the chance to receive this talking therapy.
CBTp is scarce because it can take a long time to deliver and needs to be delivered by highly trained therapists. We have adapted CBTp in several ways to make it less resource intensive. Firstly, we have targeted CBTp at only one of the problems commonly associated with psychosis – hearing voices. Secondly, this targeted approach has enabled us to reduce the number of sessions over which the therapy is conducted (from the recommended minimum of 16 sessions, down to 10 sessions). Finally, we have structured the therapy in the form of a workbook to enable briefly trained therapists to guide people through the therapy.
Our therapy is called Guided self-help CBT for distressing voices (also known as the GiVE intervention). Our briefly trained therapists are called Assistant Psychologists. They have a degree in psychology and usually work in NHS Mental Health Services under the supervision of highly trained therapists. We want to see if our GiVE intervention is helpful for people with a diagnosis of psychosis who are distressed by hearing voices, when delivered by Assistant Psychologists.
The study aims to recruit 130 people with a diagnosis of psychosis across 3 sites in England. Patients will be randomized into 2 groups:
- 65 people will continue to receive the usual support and treatments offered by their mental health team (TAU; Treatment As Usual)
- 65 people will be offered the GiVE intervention over 10 sessions, delivered by an Assistant Psychologist (GiVE+TAU)
Our findings will tell us if the GiVE intervention is helpful to people with a diagnosis of psychosis who are distressed by hearing voices, when delivered by Assistant Psychologists.
The study will also include Health Economic analysis to compare the resource requirements for each arms of the study, GiVE+TAU versus TAU alone.
Study design: Multicentre, randomised controlled, intervention trial
Disease area: Mental Health
Trial status: In follow-up
Chief Investigator: Prof Mark Hayward
Sponsor: Sussex Partnership Foundation Trust
Funder: National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB).
Start date: April 2022
End date: April 2024
Recruitment target: 130
Summary of study results: N/A
For further information contact:
E: give3@bsms.ac.uk