Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial

Garety, P. et al. (2021) Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial. Trials, 22(1), 366. (doi: 10.1186/s13063-021-05301-w) (PMID:34034792) (PMCID:PMC8145186)

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Abstract

Background: AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth ‘voices’). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU). Methods: This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued. Discussion: This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings. Trial registration: ISRCTN registry ISRCTN55682735. Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).

Item Type:Articles
Additional Information:This study is funded by The Wellcome Trust Ltd., through an Innovations Project award (grant reference 215471/Z/19/Z). The funding body has no role in the design of the study or the collection, analysis and interpretation of data or the writing of the manuscript. The work was also supported in part by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London (Prof Philippa Garety and Prof Richard Emsley). Prof Emsley is supported by an NIHR Research Professorship, (NIHR300051). Dr Mar Rus-Calafell acknowledges individual funding from the Sofja Kovalevskaja Award (Alexander von Humbold Foundation and Ministry of Education and Research, Germany). Professor Gillian Haddock acknowledges individual funding from an NIHR Senior Investigator Award (NIHR201393).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McLeod, Professor Hamish and Gumley, Professor Andrew
Authors: Garety, P., Edwards, C. J., Ward, T., Emsley, R., Huckvale, M., McCrone, P., Rus-Calafell, M., Fornells-Ambrojo, M., Gumley, A., Haddock, G., Bucci, S., McLeod, H., Hardy, A., Peters, E., Myin-Germeys, I., and Craig, T.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
Journal Name:Trials
Publisher:BioMed Central
ISSN:1745-6215
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in Trials 22(1):366
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
305108Optimising AVATAR therapy for distressing voices: a multi-centre randomised controlled trialAndrew GumleyWellcome Trust (WELLCOTR)215471/Z/19/ZHW - Mental Health and Wellbeing