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

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).

Update on Cyber Health Psychology: Virtual Reality and Mobile Health Tools in Psychotherapy, Clinical Rehabilitation, and Addiction Treatment

“…In the field of e-health mental interventions, an avatar is a digital self-representation of the person, in line with the identity and character attributed. Through the avatar, the therapist can interact with the patient and the patient can act within the virtual space, simulating behaviors and attitudes that they would display in vivo [ 34 ]. The use of avatars in e-mental health interventions represents a nascent area of inquiry.…”

Participants’ experiences of AVATAR therapy for distressing voices: a thematic qualitative evaluation

“…All the research team members who contributed to the final iteration of the coding frame have a clinical psychology or psychiatry background and, with the exception of NE, they all have been trained and have delivered AVATAR therapy and have participated in data analyses of various studies of trial data (MRC, TW, CE, PAG and TC). Two independent completers of AVATAR therapy (current members of the PPI group for the new multi-centre randomised controlled trial of AVATAR therapy ISRCTN55682735, [ 10 ]) reviewed and contributed to the refinement of wording of themes and subthemes separately.…”

“…Preliminary encouraging evidence for the efficacy of the therapy has been reported in two independent pilot studies [ 6 , 7 ] and further supported by the findings of a large fully-powered randomised controlled trial comparing AVATAR therapy and Supportive Counselling [ 8 ], which showed a post-therapy effect size of d = 0.8 on the primary outcome (total score on the Psychotic Symptom Rating Scales, auditory hallucinations subscale (PSYRATS–AH, [ 9 ]). AVATAR therapy is now being further examined for optimal delivery, effectiveness and cost-effectiveness in a new multi-centre randomised controlled trial ISRCTN55682735 [ 10 ].…”

Splitting Things Apart to Put Them Back Together Again: A Targeted Review and Analysis of Psychological Therapy RCTs Addressing Recovery From Negative Symptoms

“…Providing psychological therapies for paranoia and distressing hallucinations alongside pharmacotherapy and other medical treatments is now well-established in clinical guidelines ( 1 ) and there continues to be considerable innovation in the types of therapies being developed for positive symptoms [e.g. ( 2 , 3 )]. However, the negative symptoms of schizophrenia such as avolition-apathy and diminished expressive abilities have remained a major source of distress and arrested recovery that frequently present a significant treatment challenge ( 4 , 5 ).…”