TY - JOUR
T1 - Optimising AVATAR therapy for people who hear distressing voices
T2 - study protocol for the AVATAR2 multi-centre randomised controlled trial
AU - Garety, Philippa
AU - Edwards, Clementine J
AU - Ward, Thomas
AU - Emsley, Richard
AU - Huckvale, Mark
AU - McCrone, Paul
AU - Rus-Calafell, Mar
AU - Fornells-Ambrojo, Miriam
AU - Gumley, Andrew
AU - Haddock, Gillian
AU - Bucci, Sandra
AU - McLeod, Hamish
AU - Hardy, Amy
AU - Peters, Emmanuelle
AU - Myin-Germeys, Inez
AU - Craig, Thomas
N1 - Funding Information:
Dr Mar Rus-Calafell acknowledges individual funding from the Sofja Kovalevskaja Award (Alexander von Humbold Foundation and Ministry of Education and Research, Germany).
Funding Information:
The AVATAR therapy software is patented, intellectual property for the AVATAR therapy software system and therapy manuals is owned by the universities in collaboration between KCL, UCL and UCLB, arising from research funded by the Wellcome Trust.
Funding Information:
This study is funded by The Wellcome Trust Ltd., through an Innovations Project award (grant reference 215471/Z/19/Z).
Funding Information:
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).
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/5/25
Y1 - 2021/5/25
N2 - 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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=85106944235&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05301-w
DO - 10.1186/s13063-021-05301-w
M3 - Article
C2 - 34034792
SN - 1745-6215
VL - 22
SP - 366
JO - Trials
JF - Trials
IS - 1
M1 - 366
ER -