The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial.
BACKGROUND
Psychological interventions which adopt an explicitly interpersonal approach are a recent development in the treatment of distressing voices. AVATAR therapy is one such approach which creates a direct dialogue between a voice-hearer and a computerised representation of their persecutory voice (the avatar) through which the person may be supported to gain a sense of greater power and control. The main objective of the trial is to test the clinical efficacy of this therapy to reduce the frequency and severity of auditory verbal hallucinations (AVH). Secondary objectives of the study are to explore explanatory mechanisms of action and potential moderators, to carry out a qualitative evaluation of participants' experience and to conduct an economic evaluation.


METHODS
The AVATAR randomised clinical trial will independently randomise 142 participants to receive either 7 sessions of AVATAR therapy or supportive counselling (SC). The study population will be individuals with schizophrenia spectrum and other psychotic disorders who report hearing persistent distressing voices, for more than 12 months, which are unresponsive or only partially responsive to antipsychotic medication. The main hypotheses are that, compared to SC, AVATAR therapy will reduce the frequency and severity of AVH and will also reduce the reported omnipotence and malevolence of these voices. Assessments will occur at 0 weeks (baseline), 12 weeks (post-intervention) and 24 weeks (follow-up), and will be carried out by blinded assessors. Both interventions will be delivered in a community-based mental health centre. Therapy competence and adherence will be monitored in both groups. Statistical analysis will follow the intention-to-treat principle and data will be analysed using a mixed (random) effects model at each post treatment time point separately. A formal mediation and moderator analysis using contemporary causal inference methods will be conducted as a secondary analysis. The trial is funded by the Welcome Trust (WT).


CONCLUSIONS
AVATAR therapy showed promising effects in a pilot study, but the efficacy of the approach needs to be examined in a larger randomised clinical trial before wider dissemination and implementation in mental health services.


BACKGROUND
Current Controlled Trials
65314790 , registration date: 27 March 2013.
Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. thomas.craig@kcl.ac.uk.
Tom K J
TK
Craig
Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. maria.rus-calafell@kcl.ac.uk.
Mar
M
Rus-Calafell
Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. thomas.ward@kcl.ac.uk.
Thomas
T
Ward
Research Department of Clinical, Educational and Health Psychology University College London, London, UK. miriam.fornells-ambrojo@ucl.ac.uk.
Miriam
M
Fornells-Ambrojo
Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. paul.mccrone@kcl.ac.uk.
Paul
P
McCrone
Centre for Biostatistics, Institute of Population Health, The University of Manchester, Manchester Academic Health Science Centre, London, UK. richard.emsley@manchester.ac.uk.
Richard
R
Emsley
Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. philippa.garety@kcl.ac.uk.
Philippa
P
Garety
D001296:Audiovisual Aids; D002985:Clinical Protocols; D003196:Computer Graphics; D006212:Hallucinations / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D006801:Humans; D057194:Intention to Treat Analysis; D008131:London; D011209:Power, Psychological; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D000068356:Self-Control; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome