The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial

Trials, Aug 2015

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/Design 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). Discussion 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. Trial registration Current Controlled Trials ISRCTN: 65314790, registration date: 27 March 2013.

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The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial

Craig et al. Trials The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial Tom K.J Craig 0 3 Mar Rus-Calafell 0 3 Thomas Ward 2 Miriam Fornells-Ambrojo 1 Paul McCrone 0 3 Richard Emsley 4 Philippa Garety 2 0 Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London , London , UK 1 Research Department of Clinical, Educational and Health Psychology University College London , London , UK 2 Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London , London , UK 3 Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London , London , UK 4 Centre for Biostatistics, Institute of Population Health, The University of Manchester, Manchester Academic Health Science Centre , London , UK 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/Design: 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). Discussion: 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. Auditory hallucinations; Voices; Avatar; Psychosis; Therapy - Background Previous studies have shown that around 70 % of people with schizophrenia report auditory hallucinations [1]. Voice hearing or auditory verbal hallucination (AVH) is the most commonly reported form of auditory hallucinations [2, 3] and is typically defined as hearing a voice or other sound in the absence of an external stimulus [4]. These AVHs frequently provoke high levels of distress and interference in the daily lives of those who experience them and, therefore, have become a major target of psychological therapies for psychosis [5]. Drawing on seminal early work from Chadwick and Birchwood, cognitive models of voice- hearing propose that beliefs about voices (specifically regarding identity, power, intention and control) are key to understanding distress and maladaptive responding [6, 7]. In their model, Morrison and colleagues specifically propose that auditory hallucinations occur when a person misattributes an internal experience (e.g. intrusive thought) to an external source [8]. It is argued that subsequent maladaptive appraisal processes are maintained by safety behaviours (including selective attention), faulty self-knowledge (including metacognition), social knowledge, mood and physiology [9]. Birchwood and colleagues [10, 11] developed their model by applying social rank theory [12, 13] to voice-hearing and found that individuals who experienced powerlessness and inferiority in social relationships were more likely to report similar experiences during the voice interaction [10, 14]. It is argued that early powerlessness and perceived inferiority in social relationships establish social schemata that drive subsequent appraisals (...truncated)


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Tom Craig, Mar Rus-Calafell, Thomas Ward, Miriam Fornells-Ambrojo, Paul McCrone, Richard Emsley, Philippa Garety. The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial, Trials, 2015, pp. 349, 16, DOI: 10.1186/s13063-015-0888-6