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. 2021 May 25;22(1):366.
doi: 10.1186/s13063-021-05301-w.

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

Philippa Garety  1   2 , Clementine J Edwards  3   4 , Thomas Ward  1   2 , Richard Emsley  1 , Mark Huckvale  5 , Paul McCrone  6 , Mar Rus-Calafell  7 , Miriam Fornells-Ambrojo  5   2 , Andrew Gumley  8   9 , Gillian Haddock  10   11 , Sandra Bucci  10   11 , Hamish McLeod  8   9 , Amy Hardy  1   2 , Emmanuelle Peters  1   2 , Inez Myin-Germeys  12 , Thomas Craig  1   2
Affiliations

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

Philippa Garety et al. Trials. .

Erratum in

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).

Keywords: Auditory hallucinations; Digital health technology; Psychological intervention; Psychosis; Randomised controlled trial.

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Conflict of interest statement

Professor Sandra Bucci is the Director of Affigo, a not-for-profit community interest company designed to make apps/ digital health technologies commercially available in the NHS (http://www.affigo.io/).

Figures

Fig. 1
Fig. 1
Participant Time Schedule
See this image and copyright information in PMC

References

    1. Mawson A, Cohen K, Berry K. Reviewing evidence for the cognitive model of auditory hallucinations: the relationship between cognitive voice appraisals and distress during psychosis. Clin Psychol Rev. 2010;30(2):248–58. 10.1016/j.cpr.2009.11.006. - DOI - PubMed
    1. Waters F, Allen P, Aleman A, Fernyhough C, Woodward TS, Badcock JC, et al. Auditory hallucinations in schizophrenia and nonschizophrenia populations: a review and integrated model of cognitive mechanisms. Schizophr Bull. 2012;38(4):683–93. 10.1093/schbul/sbs045. - DOI - PMC - PubMed
    1. Turner DT, Burger S, Smit F, Valmaggia LR, van der Gaag M. What constitutes sufficient evidence for case formulation–driven CBT for psychosis? Cumulative meta-analysis of the effect on hallucinations and delusions. Schizophr Bull. 2020;46(5):1072–85. 10.1093/schbul/sbaa045. - DOI - PMC - PubMed
    1. Bighelli I, Huhn M, Schneider-Thoma J, Krause M, Reitmeir C, Wallis S, et al. Response rates in patients with schizophrenia and positive symptoms receiving cognitive behavioural therapy: a systematic review and single-group meta-analysis. BMC Psychiatry. 2018;18 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280425/. Cited 2020 Nov 11. - PMC - PubMed
    1. Haddock G, Eisner E, Boone C, Davies G, Coogan C, Barrowclough C. An investigation of the implementation of NICE-recommended CBT interventions for people with schizophrenia. J Ment Health. 2014;23(4):162-5. - PubMed

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