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

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 followup assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience.

Increasing access to cognitive–behavioural therapy for patients with psychosis by evaluating the feasibility of a randomised controlled trial of brief, targeted cognitive–behavioural therapy for distressing voices delivered by assistant psychologists: the GiVE2 trial

“…The published study protocol 11 is briefly described here. This was a feasibility RCT with a three-arm, parallel-group design and 1:1:1 allocation, comparing GiVE and treatment as usual (the study intervention) to supportive counselling and treatment as usual (the control intervention) to treatment as usual alone, recruiting across two sites, with blinded post-treatment and follow-up assessments.…”

“…There were minimal changes to the design after trial commencement, and details are reported in the study protocol. 11 The trial was registered with the ISRCTN registry (number 16166070) on 5 February 2019 ( ).…”

“…Participants were recruited over 12 months from community mental health teams and early intervention in psychosis services at two sites within the UK National Health Service (NHS): Sussex Partnership NHS Foundation Trust and Pennine Care NHS Foundation Trust. Inclusion criteria were: aged 16 years or older in contact with NHS mental health services and under the care of a consultant psychiatrist; experiencing current voice hearing (a score of 1 or more [‘At least once a day’] on item 1 [‘How frequently did you hear a voice or voices?’] of the Hamilton Program for Schizophrenia Voices Questionnaire; HPSVQ); 11 distressed by hearing voices (operationalised by participants scoring at least 8 out of 16 on the negative voice impact scale of the HPSVQ); 12 meeting DSM-5 research criteria for schizophrenia spectrum or other psychotic disorders (assessed by the Structured Clinical Interview for DSM-5 disorders 13 ); and willing and able to provide written informed consent. Exclusion criteria were: established organic cause for distressing voices (e.g.…”

“…For primary outcomes for a definitive trial, two candidate measures were used to assess voice-related distress at time points 0, 1 and 2: the five-item distress scale of the Psychotic Symptom Rating Scales (PSYRATS auditory hallucinations subscale) 18 (‘amount of negative voice content’, ‘degree of negative voice content’, ‘amount of distress’, ‘intensity of distress’ and ‘controllability of voices’) and the four-item negative voice impact scale of the HPSVQ 11 (‘How bad are the things voices say to you?’, ‘How much do the voices interfere with your daily activities?’, ‘How distressing are the voices that you hear?’ and ‘How bad do the voices make you feel about yourself?’).…”

Patient experience of Guided self-help CBT intervention for VoicEs (GiVE) delivered within a pilot randomized controlled trial

“…frontline practitioners, assistant psychologists). We are currently exploring the efficacy of GiVE delivered by assistant psychologists as part of a feasibility trial (Hayward et al, 2020).…”