Abstract AVATAR therapy is an effective relational therapy for persistent distressing auditory verbal hallucinations (voices). A digital representation of the embodied persecutory voice (avatar) is created and used in a series of dialogues in which the voice hearer is supported to be more assertive and the avatar concedes power. In the first mediation analysis of AVATAR therapy examining the role of power-related constructs, we investigate whether treatment effects on total severity, frequency, and distress of voices are mediated by changes in beliefs about voices and the self, voice relationship appraisals and anxiety. Mediation effects were evaluated in relation to decomposing treatment offer and treatment receipt effects using both Intention to treat (ITT) and Complier Average Causal Effect (CACE) analyses. One hundred and fifty participants from AVATAR1, a randomised control trial (RCT) comparing AVATAR therapy to Supportive Counselling took part in this study, with their baseline and end of treatment (12 weeks) data used. As hypothesised, across both ITT and CACE analyses, reductions in perceived voice omnipotence and increased assertiveness in relation to voices emerged as consistent mediators of AVATAR therapy on reductions in overall severity, frequency and distress of auditory hallucinations compared to SC, whereas voice malevolence, perceived power differential, self-esteem and anxiety did not. Exploratory analysis also indicated that increases in acceptance and autonomy in relation to voices mediated the impact of AVATAR therapy on overall voice severity and distress. This mediation analysis refines our understanding of AVATAR therapy and highlights agency, voice omnipotence and acceptance as intervention targets.

BackgroundAVATAR therapy is a novel psychological therapy that aims to reduce distress associated with hearing voices. The approach involves a series of therapist-facilitated dialogues between a voice-hearer and a digital embodiment of their main distressing voice (the avatar), which aim to increase coping and self-empowerment. ObjectiveThis study explored therapeutic processes that are distinctive to AVATAR therapy, including direct early work with voice content and the role of the therapist in dialogue enactment. MethodsPeople with lived experience relating to psychosis (peer researchers) contributed to each stage of the study. Peer researchers led semistructured interviews, which were conducted with 19 participants who received AVATAR therapy as part of the AVATAR2 trial, including 3 participants who dropped out of therapy. Data were analyzed using interpretative phenomenological analysis (n=5) and template analysis (n=14). ResultsParticipants described the initial challenges of experiential work with distressing voice content; however, most reported a meaningful increase in power and control over the course of dialogues and improvements with voices in daily life. A strong therapeutic alliance was experienced by all participants, including those who chose to discontinue therapy, often mitigating the discomfort associated with initial challenges by enhancing their sense of safety. Several important themes relating to individual engagement were highlighted, such as the emotional intensity of the experience and the importance of participants’ determination and open-minded attitudes despite initial doubts. Those who decided not to continue with therapy described challenges with the realism of working dialogically with a digital representation of their distressing voice. ConclusionsThis study has provided a deeper understanding of the experience of engaging in AVATAR therapy, in particular the challenges and opportunities of direct work with voice content. The importance of therapeutic alliance and establishing a sense of voice presence has been emphasized. Implications for the planned optimization and wider implementation of AVATAR therapy in routine care settings are discussed. Trial RegistrationISRCTN Registry ISRCTN55682735; https://www.isrctn.com/ISRCTN55682735

INTRODUCTION:Around 70% of people with psychosis experience auditory verbal hallucinations (AVHs), which can cause distress and impair the social functioning of the individual. AVATAR therapy works by facilitating a 'face-to-face' dialogue between the person and a digital representation (avatar) of their persecutory voice. Although there is cumulative evidence of this way of working with voices, enhancing the therapeutic focus on improved confidence and sense of control of the voices in social situations represents a promising way to boost generalisation of therapy gains into social contexts. We aim to enhance AVATAR therapy by incorporating immersive Virtual Reality (VR) social environments aiming to help the person to deal better with their voices in daily situations. METHODS AND ANALYSIS:A randomised controlled feasibility trial will be conducted. 40 patients aged 18 or above who are at early stages of psychosis (first episode of psychosis in the last five years) and report distressing and interfering voices will be recruited. Participants will be randomised to receive either a novel, enhanced version of AVATAR therapy (AVATAR_VRSocial) in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 6 months (follow--up). Key therapeutic targets of AVATAR_VRSocial will be those established by the previous evidence of this approach (ie, power and control, self-esteem and future focus), while introducing exposure and management of distressing voices during social interactions. Analyses will focus on feasibility outcomes (recruitment, retention and completion rates) and preliminary estimates of intervention effects. Qualitative interviews will be carried out with participants allocated to AVATAR_VRSocial to gain a comprehensive understanding of participants' views on the acceptability of the intervention and research procedures. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention, trial procedures and the new VR technology and software involved. ETHICS AND DISSEMINATION:The study has received ethical approval from the Ethics Commission at the Faculty of Psychology (Ruhr-Universität Bochum), and there is an independent Trial Steering Committee and Lived Experience Advisory Panel also supporting it. Findings will be disseminated through peer--reviewed publications, conference presentations and science dissemination events. TRIAL REGISTRATION NUMBER:ISRCTN35980117.

AVATAR therapy is an innovative form of relational therapy for the treatment of distressing auditory verbal hallucinations, or voice-hearing, targeted at reducing voice-related distress. AVATAR therapy involves the creation of a digital simulation of a single voice, termed an 'avatar', which is used in a series of three-way therapeutic dialogues. This paper presents the AVATAR Therapy Dialogues Corpus, a specialised corpus containing orthographic transcriptions of AVATAR therapy sessions. We offer an overview of the corpus contents, and a detailed discussion of the design and construction of the corpus. We describe the processes and specialised tools created, transcription conventions, and mark-up designed to capture para-linguistic and non-speech features which may have clinical relevance. Finally, we discuss the potential of the corpus to provide a genuine innovation in clinical care, offering clinicians a data stream that could augment their understanding of patient experiences.

Background:Early Intervention in Psychosis services improves outcomes for young people with psychosis, but 25% disengage in the first 12 months with costs to their mental health. Objectives:To refine a toolkit and training and evaluate effectiveness, implementation, and cost-effectiveness of the Early Youth Engagement-2 intervention to reduce disengagement. Design:Cluster randomised controlled trial with economic and process evaluation. Randomisation:Randomisation at team level stratified by site. Masking:Research assistants, outcome assessors and statisticians were masked to treatment allocation for the primary disengagement and cost-effectiveness outcomes. Participants and teams administering the interventions were unmasked. Setting:Twenty Early Intervention in Psychosis teams in five sites across England. Participants:A total of 1027 young people (14-35 years) with first-episode psychosis (F20-29, 31; ICD-10); 20-282 Early Intervention in Psychosis staff. Intervention:Team-based motivational engagement (Early Youth Engagement-2) intervention, delivered by Early Intervention in Psychosis clinicians alongside standardised Early Intervention in Psychosis, supported by the implementation toolkit (training, website and booklet series). Comparison:Standardised Early Intervention in Psychosis, including National Institute for Health and Care Excellence guidelines approved interventions. Main outcome measures:Primary outcome - time to disengagement over 26 months (days from date of allocation to care co-ordinator to date of last contact following refusal to engage with service, or lack of response to contact for consecutive 3-month period). Secondary outcomes - mental health, recovery, quality of life, service use, at 6 and 12 months. Economic outcomes - National Health Service mental healthcare costs, wider societal care costs, clinical and social outcomes over 12 months; cost-effectiveness. Process evaluation outcomes - fidelity to the Early Youth Engagement-2 model, implementation process scores, therapeutic alliance, qualitative outcomes. Results:Disengagement was 16% across both arms. The multivariable Cox regression on 1005 participants estimated an adjusted hazard ratio for Early Youth Engagement-2 + standardised Early Intervention in Psychosis (n = 652) versus standardised Early Intervention in Psychosis service alone (n = 375) of 1.07 (95% confidence interval 0.76 to 1.49; p = 0.713). There were no observed differences between arms for any secondary outcomes. The health economic evaluation indicated lower mean mental healthcare costs of -£788 (95% CI -£3571 to £1994) and marginally improved mental health states for intervention participants. Early Youth Engagement-2 participants spent 30 more days per year in education and training (95% CI 1.52 to 53.68; probability positive outcome for the intervention: 99%), but these outcomes must be viewed very cautiously as only 22% of the sample provided data. The process evaluation revealed heterogeneous implementation fidelity and constant pressure to adapt to widespread disruption from COVID-19. There was no effect on therapeutic alliance: the most likely active change mechanism was through psychoeducation. Limitations:Lower than expected disengagement, high loss to follow-up and impact of COVID-19 on fidelity, implementation and outcomes. Conclusions:In the primary clinical effectiveness analysis, 95% confidence limits ruled out a reduction of more than 24% in the risk of disengagement with the Early Youth Engagement-2 intervention. In a cost-effectiveness analysis, estimates fell in the direction of dominance of the Early Youth Engagement-2 intervention (reduced costs, marginally better mental health states). Future work:Dissemination of the booklet and website resources and an adapted version of the model as stand-alone tools for use in good-practice routine Early Intervention in Psychosis care. Study registration:This study is registered as ISRCTN 51629746. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/31/87) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 33. See the NIHR Funding and Awards website for further award information.

Background:Experience sampling methodology (ESM) is an assessment method used in psychosis research. Symptom severity and gender may be associated with ESM engagement. Exploring qualitative experiences of using ESM among people with psychosis should aid developing more relevant, accessible digital assessments. Objective:This study aimed to examine factors that could affect engagement with ESM, such as associations of completion rates with age, ethnicity, gender, and clinical severity. It also aimed to explore qualitatively service users' experiences of using this data collection method. Methods:Data from 134/207 AVATAR2 trial (ISRCTN55682735) participants were used to evaluate associations between demographic variables, symptom severity, and ESM completion rates. Trial participants were purposively sampled to participate in an interview to discuss their experiences of using ESM or to discuss reasons why they chose not to use it. Results:Multiple regression analyses of 134 participants found that age, gender, ethnicity, and clinical severity were not associated with ESM completion rates (F5,128=0.548; P=.74). A thematic analysis of 17 participant interviews found 3 overarching themes: Factors affecting engagement with ESM, Perceived benefits of ESM, and Suggestions for improvement. These themes described how ESM has multiple benefits for people with psychosis, including increasing knowledge and awareness of mental health. ESM was straightforward and easy to use; however, engaging in other activities, experiencing positive symptoms, little experience using technology, and trial involvement impacted engagement. Participant's decision to use ESM could be influenced by concerns about security and privacy. Conclusions:Recommendations are made on how engagement with ESM can be improved, making it easier to use this method with this population, including providing increased support or training when using digital-based assessment or intervention as well as providing information on how digital data are used and recorded.

Modern psychiatry faces challenges in translating neurobiological insights into treatments for severe illnesses. The mid-20th century witnessed the rise of molecular mechanisms as pathophysiological and treatment models, with recent holistic proposals keeping this focus unaltered. In this perspective, we explore how psychiatry can utilize systems neuroscience to develop a vertically integrated understanding of brain function to inform treatment. Using schizophrenia as a case study, we discuss scale-related challenges faced by researchers studying molecules, circuits, networks, and cognition and clinicians operating within existing frameworks. We emphasize computation as a bridging language, with algorithmic models like hierarchical predictive processing offering explanatory potential for targeted interventions. Developing such models will not only facilitate new interventions but also optimize combining existing treatments by predicting their multi-level effects. We conclude with the prognosis that the future is bright, but that continued investment in research closely driven by clinical realities will be critical.

AVATAR therapy (AT) works by facilitating a 'face-to-face' dialog between the person and a digital representation (avatar) of their persecutory voice. Although there is cumulative evidence of this way of working with voices, enhancing the therapeutic focus on improved confidence and a sense of control of the voices in social situations represents a promising way to boost the generalization of therapy gains into social contexts. This paper presents a descriptive clinical case example of AVATAR_VRSocial therapy, a new augmented version of AT incorporating immersive Virtual Reality to help the person deal better with their voices in daily situations. "Laura" is a woman who was hearing a very distressing, threatening voice. She felt anxious and distressed when anticipating hearing it and would engage in safety-seeking behaviors to prevent hearing the voice. Laura was supported to stand up to her avatar and regain power over it by using assertive responses, both in active avatar dialog and when exposed to the avatar voice in VR scenarios, which turned into reduced distress when hearing the voice in her everyday life. Laura's dialog with her avatar evolved into a more explicit exploration of the meaning and the purpose of the voice in relation to previous trauma and personal relationships. The additional work in VR appeared to facilitate exposure to social situations while hearing the distressing voice, without performing seeking-safety behaviors, and to allow for practicing strategies to reduce the voice's interference, which evolved from the dialogic sessions with the personalized avatar.

BackgroundDespite the promise of digital therapeutics in providing scalable interventions for psychosis, translating them from clinical trials to routine care is challenging. SloMo is an evidence-based, digitally supported cognitive behavioral therapy for psychosis comprising a web-based therapy platform and mobile app. The therapy encourages individuals to slow down for a moment, to address fast-thinking habits fueling paranoia. SloMo has received a NICE Early Value Assessment recommendation for use in the National Health Service to address evidence gaps related to its use in the real world, and an implementation study is underway. ObjectiveThis study aimed to optimize the SloMo software for implementation by addressing limitations of the first release, reducing technology complexity, and improving user experience, to increase equitable outcomes. MethodsAn inclusive, human-centered design methodology was used to optimize SloMo. The redesign sought to reduce the technology’s complexity and improve the user experience for diverse patients and therapists. The Double Diamond framework structured the iterative redesign, integrating insights from patient and public involvement consultants, therapists, and a transdisciplinary co-design team. The Double Diamond process was facilitated through 24 transdisciplinary workshops. These were supported by the following methods: identifying implementation barriers through desk research of SloMo’s evidence and qualitative interviews with experts by experience (n=2); redefining user needs; iteratively developing solutions through user testing sessions with service user consultants (n=32); and validating the minimum viable product through think-aloud testing sessions with therapist (n=10) and service user (n=11) consultants. ResultsUsers wanted a form of cognitive behavioral therapy for psychosis that was usable, trustworthy, enjoyable, personalized, normalizing, and memorable. The redesign, therefore, included a minimalist user interface, more diverse lived experience vignette content, enhanced agency over data, greater representation of protected characteristics and their intersectionality, and intuitive navigation. Feedback from a purposively sampled patient and therapist sample validated the redesign as it was associated with a strong user experience, particularly in relation to usability and usefulness. ConclusionsThe study produced a redesign of the SloMo software optimized for real-world use, whilst retaining fidelity to the therapeutic content of the previous version. Through an inclusive, human-centered approach, the optimized design of SloMo addresses barriers to adoption by reducing complexity and fostering accessibility. This study underscores the value of integrating lived experience involvement into digital therapeutics to support scalable, equitable, and sustainable mental health care solutions.

BACKGROUND:Early intervention in psychosis (EIP) services improve outcomes for young people, but approximately 30% disengage. AIMS:To test whether a new motivational engagement intervention would prolong engagement and whether it was cost-effective. METHOD:We conducted a multicentre, single-blind, parallel-group, cluster randomised controlled trial involving 20 EIP teams at five UK National Health Service (NHS) sites. Teams were randomised using permuted blocks stratified by NHS trust. Participants were all young people (aged 14-35 years) presenting with a first episode of psychosis between May 2019 and July 2020 (N = 1027). We compared the novel Early Youth Engagement (EYE-2) intervention plus standardised EIP (sEIP) with sEIP alone. The primary outcome was time to disengagement over 12-26 months. Economic outcomes were mental health costs, societal costs and socio-occupational outcomes over 12 months. Assessors were masked to treatment allocation for primary disengagement and cost-effectiveness outcomes. Analysis followed intention-to-treat principles. The trial was registered at ISRCTN51629746. RESULTS:Disengagement was low at 15.9% overall in standardised stand-alone services. The adjusted hazard ratio for EYE-2 + sEIP (n = 652) versus sEIP alone (n = 375) was 1.07 (95% CI 0.76-1.49; P = 0.713). The health economic evaluation indicated lower mental healthcare costs linked to reductions in unplanned mental healthcare with no compromise of clinical outcomes, as well as some evidence for lower societal costs and more days in education, training, employment and stable accommodation in the EYE-2 group. CONCLUSIONS:We found no evidence that EYE-2 increased time to disengagement, but there was some evidence for its cost-effectiveness. This is the largest study to date reporting positive engagement, health and cost outcomes in a total EIP population sample. Limitations included high loss to follow-up for secondary outcomes and low completion of societal and socio-occupational data. COVID-19 affected fidelity and implementation. Future engagement research should target engagement to those in greatest need, including in-patients and those with socio-occupational goals.

BACKGROUND:For voice-hearers from minoritised communities, voices may reflect interpersonal and societal discrimination, including experiences of feeling silenced or 'voiceless'. AVATAR therapy is a relational approach involving facilitated dialogues between a voice-hearer and a digital embodiment of their main distressing voice (the avatar). The aim is for the voice hearer to gain understanding, acceptance and empowerment. AIMS:This paper illustrates an extended form of AVATAR therapy (AV-EXT), which seeks to understand a person's voices within their developmental and relational context. METHODS:We present three therapy narratives in which voices mirrored experiences of discrimination and marginalisation based on aspects of the person's identity. Personalised avatars were used during dialogues to re-enact the lived experience of voice-hearing. RESULTS:Avatar dialogues offered opportunities to rescript disempowering experiences, target associated meanings and connect individuals with the power of their own identity. CONCLUSIONS:Implications for the continued refinement of AVATAR therapy and other relational approaches are considered. This paper aims to support wider reflection on the impact of discrimination on distressing voices.

This article describes a Patient and Public Involvement (PPI) led creative workshop space held within a clinical trial of a talking therapy for distressing voices (AVATAR2). PPI adds significant value to clinical research and ensures the work is meaningful to patients and their supporters. However, known issues include tokenism, a common power imbalance between PPI colleagues and researchers and a lack of opportunity for PPI to shape the research. PPI has played a key role at all stages of the AVATAR2 trial, including design, recruitment of staff and participants, data collection, analysis, and dissemination. An active and creative group of people was established, with over 30 members flexibly involved across all four sites. PPI group members were from diverse backgrounds, with lived experience of mental health conditions and recovery, and including carers. During this work, PPI colleagues identified that they would value a creative space which would help to promote the study but extend beyond an exclusive focus on trial deliverables. A regular creative workshop was established to support PPI colleagues in their creative work, including material such as poetry, blogs, art and podcasts. PPI colleagues and trial staff have cowritten a reflective piece to share their experiences on the impact of the creative workshops, organised into four themes. We found the workshops to be a powerful tool for forging relationships among trial staff and PPI colleagues, while also fostering personal development. We reflected on how the workshops built up the confidence of attendees and supported demanding trial activities such as public speaking. Finally, we discussed the impact of the workshops on wider trial culture, by upholding the values of the team and challenging the status quo.

Purpose Although the development of digital mental health support for people with psychosis has been increasing, the development and opportunities to access this have been more limited compared to other mental health conditions. Qualitative research exploring the experiences of using digital interventions amongst people with psychosis is even less well developed; however, such research is crucial in capturing the experiences of using digital interventions to ensure they are meeting the needs of people with psychosis. This paper aimed to synthesise qualitative data related to the experiences of people with psychosis who have used digital interventions.Methods A systematic literature search was conducted of articles published between 1992 and October 2023 using PubMed, MBase, PsycINFO, & OVID Medline. Two reviewers independently reviewed and screened 268 papers. Papers that met inclusion criteria were quality assessed using The Critical Appraisal Skills Programme (CASP) qualitative studies checklist. The Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) checklist was used to guide the structure of the report.Results A thematic synthesis of 19 studies revealed six overarching themes which related to different aspects and features of the digital interventions: participants' relationship with technology; the accessibility of the interventions; how the interventions could impact on individuals' awareness and management of mental health; enhanced communication and relationships; and opportunities for reflection.Conclusions Benefits of using digital interventions are discussed. Areas for development and improvements are highlighted. Finally, recommendations for stakeholders who develop and implement digital interventions for psychosis are made.

This paper explores AVATAR therapy, an innovative therapeutic intervention for people experiencing auditory verbal hallucinations (AVH), where participants interact with their ‘voice’ in the form of a co-designed visual representation of their voice. Previous research has found AVATAR therapy to be successful in its aim to initiate change in the participant’s relationship to and experience of their voice, but no study has explored the interactional practices employed as they unfold in this complex multiparty interaction between therapist, participant and avatar voiced by the therapist. We build on previous research and explore what it is about this interactional technique that might be contributing to the efficacy of this therapy. Using conversation analysis, we examine the therapist’s use of ‘hypothetical active voicing’ (HAV), where the therapist formulates a proposed turn at talk in their interaction with the participant for the participant to reformulate in their next turn with the avatar. We show how, unlike in traditional dyadic therapeutic settings, participants are immediately able to enact the therapist-suggested dialogue. We find that as the therapist increases their assertiveness, control and precision in the delivery of HAV, so does the participant increase their assertiveness towards the avatar, thus contributing to the aims of the therapy

Digital technology is positioned as a potential solution to improving access, experience, and outcomes of psychological therapies for psychosis. Digital solutions need to be fit for purpose and tailored to context to deliver real world benefits. To address this, co-production is often used, where stakeholder involvement informs intervention development. However, co-production in clinical research tends to limit involvement to refining previously identified solutions to known problems. This is not an optimal approach to innovation and risks maintaining inequities. An alternative is inclusive co-design, where the needs of a diverse range of people are collaboratively explored using ethnography, and solutions to address these iteratively developed through user testing. In healthcare, we propose an evidence-based approach to co-design ('hybrid waterfall-agile') is required. This is because 'agile' exploration of needs and solutions is necessarily constrained by clinical guidelines and regulatory requirements (the 'waterfall'). This paper provides an overview of evidence-based co-design. We use the example of SloMo, a blended digital therapy for paranoia. We describe our transdisciplinary team collaboration and how this facilitates inclusive lived experience involvement. Our therapy development method is outlined, illustrated by reflections from lived experience team members. Iterative divergent ('zooming out') and convergent ('honing in') cycles are used to co-design therapy functionality, aesthetics, interactions, and content, supported by stakeholder engagement. We conclude by reflecting on common challenges including sustaining lived experience involvement, adherence to evidence base, regulatory compliance, funding, and project management. Recommendations for navigating these obstacles are provided, with the aim of encouraging innovation in mental healthcare for psychosis.

AIM:Psychosis is associated with significant health and societal costs. Early intervention in psychosis services (EIP) are highly effective in promoting recovery, yet substantial proportions of young people disengage. The current study aimed to develop and evaluate a novel engagement intervention in EIP services. METHOD:A qualitative investigation of facilitators and barriers to engagement in 68 first episode psychosis patients, family members and young people, and a Delphi consultation with 27 regional and national youth and psychosis service leads informed the development of the intervention. A mixed-methods feasibility-pilot study then compared engagement outcomes in 298 EIP service users in two cohorts: standard EIP versus standard EIP plus the novel early youth-engagement (EYE) intervention. A qualitative study explored intervention experiences in 22 randomly selected service users, carers and clinicians. A process evaluation explored delivery. RESULTS:Disengagement was 24% in the standard EIP cohort compared to 14.5% in the standard EIP plus EYE intervention cohort. A 95% Bayesian credibility interval revealed a 95% probability that the true reduction in disengagement lay somewhere between 0% and 18%. The number needed to treat was 11, 95% CI [5, 242]. Use of the EYE resources was associated with engagement. Qualitiative feedback supported effects on communication, social network engagement, service user goals, mental health and well-being outcomes. CONCLUSION:The EYE intervention was designed from a service user, young person and carer perspective. Both qualitative and quantitative data support impacts on engagement. We now need to evaluate effectiveness, cost-effectiveness and implementation in a multi-site randomised controlled 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 .

Aim There is growing interest in tailoring psychological interventions for distressing voices and a need for reliable tools to assess phenomenological features which might influence treatment response. This study examines the reliability and internal consistency of the Voice Characterisation Checklist (VoCC), a novel 10-item tool which assesses degree of voice characterisation, identified as relevant to a new wave of relational approaches. Methods The sample comprised participants experiencing distressing voices, recruited at baseline on the AVATAR2 trial between January 2021 and July 2022 ( n = 170). Inter-rater reliability (IRR) and internal consistency analyses (Cronbach’s alpha) were conducted. Results The majority of participants reported some degree of voice personification (94%) with high endorsement of voices as distinct auditory experiences (87%) with basic attributes of gender and age (82%). While most identified a voice intention (75%) and personality (76%), attribution of mental states (35%) to the voice (‘What are they thinking?’) and a known historical relationship (36%) were less common. The internal consistency of the VoCC was acceptable (10 items, α = 0.71). IRR analysis indicated acceptable to excellent reliability at the item-level for 9/10 items and moderate agreement between raters’ global (binary) classification of more vs. less highly characterised voices, κ = 0.549 (95% CI, 0.240–0.859), p < 0.05. Conclusion The VoCC is a reliable and internally consistent tool for assessing voice characterisation and will be used to test whether voice characterisation moderates treatment outcome to AVATAR therapy. There is potential wider utility within clinical trials of other relational therapies as well as routine clinical practice.