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11 result(s) for "Edwards, Clementine J."
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Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial
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).
Psychological Therapies for Schizophrenia and Other Primary Psychotic Disorders: Toward Precision, Personalization, and Real-World Impact
Abstract For many decades, psychological therapies were largely withheld from people with schizophrenia and other primary psychotic disorders (SPD). This was due, to a predominantly biological view of these conditions and concerns that addressing psychotic symptoms through psychological methods could harm patients by excaberating psychosis. Since the 1950s, however, psychological treatment approaches have evolved considerably, becoming evidence-based and now recommended by best practice guidelines for individuals with SPD. Nevertheless, there is a need for continued research to improve therapeutic outcomes for this population. This editorial introduces the themed issue “Psychological Therapies for Schizophrenia and Other Primary Psychotic Disorders: Toward Precision, Personalization, and Real-World Impact.” The issue brings together innovative work at the intersection of translational science, personalized care, and ecological validity. The contributions highlight advances in mechanism-based interventions, understanding individual trajectories and treatment responses, and the integration of daily-life assessment and intervention through digital and mobile technologies. Collectively, this themed issue illustrates the energy and creativity with which the field is addressing the evolving needs of individuals with SPD. However, unresolved challenges remain. These efforts include the broad and accessible implementation of evidence-based approaches, as well as the active involvement of individuals with lived experience of psychosis in the development, evaluation, and implementation of new interventions.
Economic evaluation of digitally supported therapy for people with psychosis who hear distressing voices: the AVATAR2 trial
AVATAR therapy, a digitally supported intervention, utilises avatars to promote recovery in people who experience distressing auditory hallucinations. This approach was recently evaluated in a multicentre randomised controlled trial comparing brief (AV-BRF) and extended (AV-EXT) forms of therapy with treatment as usual (TAU). There was evidence for the effectiveness of therapy, particularly for AV-EXT. However, value for money needs to be assessed. To compare separately the cost utility of the brief and extended forms of AVATAR therapy with TAU. In a three-arm randomised controlled trial the use of health services was measured, and costs (2021/2022; pounds sterling) calculated from a health and social care perspective over a 28-week follow-up period. Quality-adjusted life years (QALYs; derived from the 5-level version of the EuroQol 5-Dimension questionnaire) were combined with costs. AV-BRF resulted in extra costs of £319 (95% CI, -£1558 to £2496), and AV-EXT in lower costs of £1965 (95% CI, -£1912 to £1519), compared with TAU. Over the follow-up, AV-BRF resulted in 0.0159 (95% CI, -0.0103 to 0.0422) and AV-EXT in 0.0173 (95% CI, -0.0049 to 0.0395) more QALYs than TAU. The cost per QALY for AV-BRF compared with TAU was £20 016, while AV-EXT dominated TAU (lower costs and more QALYs). Neither version of AVATAR had a substantial impact on QALYs. However, AV-EXT did result in reduced care costs - albeit not statistically significant - and was potentially cost-effective compared with TAU. AV-BRF had an incremental cost-effectiveness ratio that indicated lower potential cost-effectiveness. These findings are uncertain, but could still inform decision-making regarding interventions in this field.
Digital AVATAR therapy for distressing voices in psychosis: the phase 2/3 AVATAR2 trial
Distressing voices are a core symptom of psychosis, for which existing treatments are currently suboptimal; as such, new effective treatments for distressing voices are needed. AVATAR therapy involves voice-hearers engaging in a series of facilitated dialogues with a digital embodiment of the distressing voice. This randomized phase 2/3 trial assesses the efficacy of two forms of AVATAR therapy, AVATAR-Brief (AV-BRF) and AVATAR-Extended (AV-EXT), both combined with treatment as usual (TAU) compared to TAU alone, and conducted an intention-to-treat analysis. We recruited 345 participants with psychosis; data were available for 300 participants (86.9%) at 16 weeks and 298 (86.4%) at 28 weeks. The primary outcome was voice-related distress at both time points, while voice severity and voice frequency were key secondary outcomes. Voice-related distress improved, compared with TAU, in both forms at 16 weeks but not at 28 weeks. Distress at 16 weeks was as follows: AV-BRF, effect −1.05 points, 96.5% confidence interval (CI) = −2.110 to 0, P  = 0.035, Cohen’s d  = 0.38 (CI = 0 to 0.767); AV-EXT −1.60 points, 96.5% CI = −3.133 to −0.058, P  = 0.029, Cohen’s d  = 0.58 (CI = 0.021 to 1.139). Distress at 28 weeks was: AV-BRF, −0.62 points, 96.5% CI = −1.912 to 0.679, P  = 0.316, Cohen’s d  = 0.22 (CI = −0.247 to 0.695); AV-EXT −1.06 points, 96.5% CI = −2.700 to 0.586, P  = 0.175, Cohen’s d  = 0.38 (CI = −0.213 to 0.981). Voice severity improved in both forms, compared with TAU, at 16 weeks but not at 28 weeks whereas frequency was reduced in AV-EXT but not in AV-BRF at both time points. There were no related serious adverse events. These findings provide partial support for our primary hypotheses. AV-EXT met our threshold for a clinically significant change, suggesting that future work should be primarily guided by this protocol. ISRCTN registration: ISRCTN55682735 . A randomized controlled trial involving people with psychosis who hear distressing voices reported that two different forms of AVATAR therapy, an intervention where voice-hearers engage with a digital avatar representing this distressing voice, reported further improvements in voice-related distress at 16 weeks but not at 28 weeks on top of standard of care.
The role of characterisation in everyday voice engagement and AVATAR therapy dialogue
Voices are commonly experienced as communication with a personified 'other' with ascribed attitudes, intentionality and personality (their own 'character'). Phenomenological work exploring voice characterisation informs a new wave of relational therapies. To date, no study has investigated the role of characterisation in behavioural engagement with voices or within psychological therapy for distressing voices. Baseline characterisation (the degree to which the voice is an identifiable and characterful entity) of the dominant voice was rated (high, medium or low) using a newly developed coding framework, for n = 60 people prior to starting AVATAR therapy. Associations between degree of characterisation and (i) everyday behavioural engagement with voices (The Beliefs about Voices Questionnaire-Revised; n = 60); and (ii) interaction within avatar dialogue [Session 4 Time in Conversation (participant-avatar); n = 45 therapy completers] were explored. Thirty-three per cent reported high voice characterisation, 42% medium and 25% low. There was a significant association between characterisation and behavioural engagement [H(2) = 7.65, p = 0.022, ɛ2 = 0.130] and duration of participant-avatar conversation [F(2,42) = 6.483, p = 0.004, η2 = 0.236]. High characterisation was associated with increased behavioural engagement compared with medium (p = 0.004, r = 0.34; moderate effect) and low (p = 0.027, r = 0.25; small-moderate effect) with a similar pattern observed for the avatar dialogue [high v. medium: p = 0.008, Hedges' g = 1.02 (large effect); high v. low: p = 0.023, Hedges' g = 1.03 (large effect)]. No differences were observed between medium and low characterisation. Complex voice characterisation is associated with how individuals interact with their voice(s) in and out of therapy. Clinical implications and future directions for AVATAR therapy and other relational therapies are discussed.
The Impact of AVATAR Therapy on Voice Hearing in Everyday Life: ESM Outcomes of the AVATAR2 Trial
Abstract AVATAR therapy involves facilitated dialogs between a voice hearer and a digital embodiment of their distressing voice (“the avatar”). We conducted a multi-site single-blind randomized controlled trial to evaluate the efficacy of brief (AV-BRF) and extended (AV-EXT) forms of AVATAR therapy, compared with treatment as usual (TAU) alone (AVATAR2). This study reports the data from experience sampling method (ESM) assessments conducted at baseline, end of therapy (16 weeks), and follow-up (28 weeks). The research questions focused on whether those in the AV-BRF or AV-EXT arms experienced less voice-related distress, anxiety, and beliefs as measured by ESM, compared to TAU. Separate mixed-effects models were fitted for each research question. The final sample (n = 200) completed approximately 40% of questionnaires across all timepoints. Participants who received AV-EXT therapy, but not AV-BRF, reported reduced momentary voice-related distress at 16 (P = .022) and 28 weeks (p = .029). Appraisals of voice control were also reduced in the AV-EXT arm at 16 weeks when the voice was present (P = .002) or not (P = .008). Voice power appraisals were reduced (P < .035) in both arms when the voice was “not present but on my mind” at all timepoints. There were no changes in the frequency of voice hearing, appraisals of voice intent, or assertive responding. These findings from everyday life, reported for the first time, provide evidence of the impact on the primary AVATAR therapy treatment targets, including appraisals of voice power and control. The weight of evidence favors the AV-EXT protocol in the further development and implementation of AVATAR therapy.
The Role of Sense of Voice Presence and Anxiety Reduction in AVATAR Therapy
AVATAR therapy offers a unique therapeutic context that uses virtual reality technology to create a virtual embodiment of the voice-hearing experience, enabling the person to visualize their persecutory voice and engage in real-time “face-to-face” dialogue. The present study explores, for the first time, the contribution of sense of voice presence, together with session-by-session reduction of anxiety and paranoid attributions about the avatar, to changes in primary outcomes following AVATAR therapy. Data from 39 participants, who completed AVATAR therapy and attended a 12-week follow-up assessment, were analysed. Mid- to high-levels of sense of voice presence were reported across the therapy sessions, along with significant reductions of anxiety levels and paranoid attributions about the avatar. The interaction of sense of voice presence and reduction of anxiety was associated with two of the significant therapy outcomes: PSYRATS total and frequency of voices. The findings suggest that improvements in voice severity and frequency at post AVATAR therapy may be influenced by the combination of feeling less anxious in the context of a realistic simulation of the voice, while voice-related distress may involve additional cognitive and relational processes.
Participants’ experiences of AVATAR therapy for distressing voices: a thematic qualitative evaluation
Background AVATAR therapy is an innovative therapy designed to support people with distressing voices. Voice hearers co-create a digital representation of their voice and engage in dialogue with it. Although it has been successfully tested in a powered randomised controlled trial (ISRCTN65314790), the participants’ experience of this therapy has not been yet evaluated. We aimed to explore enablers and barriers to engagement with the therapy and potential for real-world impact on distressing voices. Methods Thirty per cent of those who completed AVATAR therapy (15 people in total) and 5 who dropped out from therapy within the main AVATAR RCT were invited to participate in a semi-structured interview, which was audio-recorded and subsequently transcribed. Results Fourteen therapy completers (28% of the full sample) and one person who dropped out of therapy after 1 active session, were interviewed. Thematic analysis was used to explore the interviews. A total of 1276 references were coded, and five overarching themes identified: AVATAR therapy set-up; voice embodiment and associated emotions; working in a safe space (supported by the therapist); learning new ways of relating to the voices; impact of therapy on everyday life. Overall, the therapy set-up, with its digital components and its distinctive features as compared with common face-to-face talking therapies, was satisfactory. The inclusion of technology was well accepted as both a means to deliver the therapy and a tool to create a digital representation of the person’s distressing voice. The co-creation of the avatar and the enactment of the relationship between the person and the voice were perceived as a very helpful process to promote the therapeutical dialogue. Participants reported engaging well with the therapist and feeling supported and identified specific learnt strategies to deal with the voices and how they have had an impact on everyday life. Conclusions AVATAR therapy is acceptable and provides benefit for participants with psychosis. Our results highlighted the enablers and challenges of working dialogically with distressing voices using a digital representation and dealing with highly demanding emotional, cognitive, and relational processes linked to the experience. Our analysis also identified the core strategies learnt by participants and how these were generalised to their daily life resulting into a positive change in different domains, and in particular broader social relationships.