Award Title: Increasing access to CBT for psychosis patients: a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by Assistant Psychologists (GiVE3)
Funder: Department of Health and Social Care

Abstract: Background   Psychosis is a severe mental health problem that is typified by the symptoms of delusional beliefs and auditory hallucinations ( voices ). These symptoms cause significant distress and disability to patients. Cognitive Behaviour Therapy for psychosis (CBTp) has strong evidence for its clinical and cost effectiveness and is recommended for all psychosis patients by the National Institute for Health & Care Excellence (NICE). Despite this recommendation, CBTp is rarely made available to psychosis patients within NHS Mental Health Services - partly due to a lack of resources. NICE have requested that research be conducted to explore ways of delivering CBTp in less resource-intensive forms. A recent innovation that may be useful in this respect is the development and evaluation of single-symptom forms of CBTp.      Aims   The long-term aim of this research is to increase the number of psychosis patients who are able to access CBTp. Specifically, the proposed study seeks to evaluate a less resource-intensive CBT-informed intervention specifically targeted at the psychosis symptom of distressing voices. Our Guided, self-help CBT intervention for voices (the GiVE intervention) is less resource-intensive in two ways: firstly, the number of sessions (10 sessions as opposed to the recommended minimum of 16 sessions); and secondly, the structure and targeted nature of the intervention which creates potential for it to be delivered by briefly trained therapists (Assistant Psychologists; APs), as opposed to highly trained therapists.     Research question   In comparison to usual care, is the GiVE intervention effective at treating distressing voices when delivered to psychosis patients by briefly trained APs?     Plan of Investigation   The proposed study will be a pragmatic, two-arm RCT comparing a Guided, self-help CBT intervention for voices (the GiVE intervention – delivered by APs) 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.      Potential benefits to patients and the NHS   If the GiVE intervention is found to be effective when delivered by APs, this intervention could significantly increase access to CBT-informed interventions for psychosis patients distressed by hearing voices. Implementation across secondary care services could pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. Increased access to CBT-informed interventions as part of a pathway of evidence-based interventions will generate benefits for: 1) individual patients (reduced distress and enhanced recovery); 2) service-level patient benefit (increased access to evidence-based psychological therapies); and 3) economic benefits to the NHS (in terms of the reduced use of high cost mental health services).

Lay Abstract: Aims   Our research aims to give more people with a diagnosis of psychosis the chance to receive a helpful talking therapy.      Background   Psychosis is a severe form of mental health condition. People with a diagnosis of psychosis may experience distressing delusional beliefs and hearing voices. The National Institute for Health & Care Excellence 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 reduce its length and 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 intervention 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 hear voices, when delivered by Assistant Psychologists.       Design and methods used   We have successfully completed a smaller version of this study. The lessons that we learnt from the smaller version have helped us to design this larger study.      We will include 130 people with a diagnosis of psychosis in our study:    65 people will be offered the GiVE intervention over 10 sessions, delivered by an Assistant Psychologist  65 people will continue to receive the usual support and treatments offered by their mental health team      Our findings will tell us if the GiVE intervention is helpful to people with a diagnosis of psychosis who hear voices, when delivered by Assistant Psychologists.      Patient and Public involvement   PPI is an integral part of the study management team and our study approach.      The Lived Experience Advisory Panel (LEAP) has contributed by:    Helping to design the GiVE intervention  Deciding the type of therapists who will deliver the GiVE intervention  Advising on the duration of the GiVE intervention and how to deliver it   In the future, the LEAP will contribute by:    Reviewing the study documents  Helping study recruitment  Understanding and sharing our findings.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH