Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures.

BACKGROUND: Given the rapid expansion of research into digital health interventions (DHIs) for severe mental illness (SMI; eg, schizophrenia and other psychosis diagnoses), there is an emergent need for clear safety measures. Currently, measurement and reporting of adverse events (AEs) are inconsistent across studies. Therefore, an international network, iCharts, was assembled to systematically identify and refine a set of standard operating procedures (SOPs) for AE reporting in DHI studies for SMI. DESIGN: The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature. RESULTS: A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified. CONCLUSIONS: The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems.

Internet-based psychoeducation and support programme for relatives of young people with early psychosis: results of the first German-language intervention.

Background: International clinical guidelines recommend Family Interventions (FIs) especially for families of people at early stages of psychosis. The German S3 treatment guideline for schizophrenia gives FIs the highest level of clinical recommendation. However, some family relatives have limited access to these services due to health system constrains. Digital interventions have emerged as a solution to overcome this hindered access to evidence-based family interventions. Objective: The present pilot study evaluates the feasibility and potential efficacy of the first German moderated online psychoeducation and support programme (ePSP) for relatives of people with early psychosis, with the additional purpose to improve accessibility and reduce waiting times. Methods: A pre-post study was performed. A brief recruitment period was pre-established (10 weeks) to test potential improvement of regular therapy waiting times in Germany. A total of 25 relatives of people with early psychosis were recruited and received the 12-week moderated online intervention. Assessments were conducted at baseline and at post intervention. Acceptance of the intervention and the user's experience were also evaluated at post intervention. Results: Recruitment, retention rates and qualitative data support the feasibility and acceptability of the ePSP. Significant positive effects of the interventions were found on key therapeutic targets, including both primary outcomes (i.e., perceived stress and beliefs about the illness). Twenty-one participants also completed the open-ended questions of the user experience questionnaire, which yielded three main themes: most important modules, difficulties in using the programme and ways to improve ePSP. Discussion: These results provide preliminary efficacy estimates for a fully powered RCT to investigate superiority (or equipoise) effects of the ePSP in comparison to the routine face-to-face family therapy groups. This future RCT will also allow further exploration of ePSP to improve access to psychological therapy for relatives of young people with psychosis, also in relation to the new ground-breaking Digital Healthcare Act in Germany.

The voice characterisation checklist: psychometric properties of a brief clinical assessment of voices as social agents.

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.

A new Algorithm for Detecting Clinical High Risk of Psychosis in Adolescents.

BACKGROUND: The delimitation of the clinical high risk of psychosis (CHRp) is characterized by the wide variety of symptoms assessed from different approaches from the onset of psychosis. This study aimed to create a systematic procedure for an effective and accurate earlydetection of CHRp in educational settings. METHOD: A representative sample of 1,824 adolescents (average age, 15.79; 53.8%, women) was used to develop an online assessment system and a new 3-track, 3-level algorithm that combines symptoms of the main risk approaches: ultra-high risk (UHR), basic symptoms (BS), and anomalies in the subjective self-experience (ASE) with functional deficit. RESULTS: The acceptability and feasibility of the online screening system were confirmed by the data. Of the total participants, 68 (3.7%) were identified as high-risk and 417 (22.9%) were identified as moderate, which also supports the functionality of the proposed algorithm. CONCLUSIONS: The system indicates a dynamic model of progression of the different symptoms in the early stages of psychosis, and it may constitute a first line of identification for severe mental disorders in young people in the earliest stages, allowing application of initial preventive measures.

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.

The service user experience of SlowMo therapy: A co-produced thematic analysis of service users' subjective experience.

OBJECTIVES: SlowMo is the first blended digital therapy for paranoia, showing significant small-moderate reductions in paranoia in a recent large-scale randomized controlled trial (RCT). This study explored the subjective service-user experience of the SlowMo therapy content and design; the experience of the blended therapy approach, including the triangle of the therapeutic alliance; and the experience of the digital aspects of the intervention. DESIGN: Qualitative co-produced sub-study of an RCT. METHODS: Participants were 22 adult service users with schizophrenia-spectrum psychosis and persistent distressing paranoia, who completed at least one SlowMo therapy session and a 24-week follow-up, at one of 3 sites in Oxford, London, and Sussex, UK. They were interviewed by peer researchers, using a topic guide co-produced by the Patient and Public Involvement (PPI) team. The transcribed data were analysed thematically. Multiple coding and triangulation, and lay peer researcher validation were used to reach a consensus on the final theme structure. RESULTS: Six core themes were identified: (i) starting the SlowMo journey; (ii) the central role of the supportive therapist; (iii) slowing things down; (iv) value and learning from social connections; (v) approaches and challenges of technology; and (vi) improvements in paranoia and well-being. CONCLUSIONS: For these service users, slowing down for a moment was helpful, and integrated into thinking over time. Learning from social connections reflected reduced isolation, and enhanced learning through videos, vignettes, and peers. The central role of the supportive therapist and the triangle of alliance between service user, therapist, and digital platform were effective in promoting positive therapeutic outcomes.

SlowMo therapy, a new digital blended therapy for fear of harm from others: An account of therapy personalisation within a targeted intervention.

OBJECTIVES: SlowMo therapy is a pioneering blended digital therapy for paranoia, augmenting face-to-face therapy with an interactive 'webapp' and a mobile app. A recent large-scale trial demonstrated small-moderate effects on paranoia alongside improvements in self-esteem, worry, well-being and quality of life. This paper provides a comprehensive account of therapy personalisation within this targeted approach. DESIGN: Case examples illustrate therapy delivery and descriptive data are presented on personalised thought content. METHOD: Thought content was extracted from the webapp (n = 140 participants) and coded using newly devised categories: Worries: (1) Persecutory, (2) Negative social evaluation, (3) Negative self-concept, (4) Loss/life stresses, (5) Sensory-perceptual experiences and (6) Health anxieties. Safer thoughts: (1) Safer alternative (specific alternatives to worries), (2) Second-wave (generalised) coping, (3) Positive self-concept, (4) Positive activities and (5) Third-wave (mindfulness-based) coping. Data on therapy fidelity are also presented. RESULTS: Worries: 'Persecutory' (92.9% of people) and 'Negative social evaluation' (74.3%) were most common. 'General worries/ life stresses' (31.4%) and 'Negative self-concept' (22.1%) were present in a significant minority; 'Health anxieties' (10%) and 'Sensory-perceptual' (10%) were less common. Safer thoughts: 'Second-wave (general) coping' (85%), 'Safer alternatives' (76.4%), 'Positive self-concept' (65.7%) and 'Positive activities' (64.3%) were common with 'Third-wave' (mindfulness) coping observed for 30%. Fidelity: Only three therapy withdrawals were therapy related. Session adherence was excellent (mean = 15.2/16; SD = 0.9). Behavioural work was conducted with 71% of people (119/168). CONCLUSION: SlowMo therapy delivers a targeted yet personalised approach. Potential mechanisms of action extend beyond reasoning. Implications for cognitive models of paranoia and causal interventionist approaches are discussed.

The impact of Patient and Public Involvement in the SlowMo study: Reflections on peer innovation.

BACKGROUND: The SlowMo study demonstrated the effects of SlowMo, an eight-session digitally supported reasoning intervention, on paranoia in a large-scale randomized-controlled trial with 362 participants with schizophrenia-spectrum psychosis. AIM: The current evaluation aimed to investigate the impact of Patient and Public Involvement (PPI) in the SlowMo study. METHOD: PPI members were six women and three men from Sussex, Oxford and London with experience of using mental health services for psychosis. They received training and met at least 3-monthly throughout the project. The impact of PPI was captured quantitatively and qualitatively through (i) a PPI log of recommendations and implementation; (ii) written subjective experiences of PPI members; (iii) meeting minutes; and (iv) outputs produced. RESULTS: The PPI log revealed 107 recommendations arising from PPI meetings, of which 87 (81%) were implemented. Implementation was greater for recruitment-, data collection- and organization-related actions than for dissemination and emergent innovations. Qualitative feedback revealed impacts on study recruitment, data collection, PPI participants' confidence, knowledge, career aspirations and society more widely. Outputs produced included a film about psychosis that aired on BBC primetime television, novel webpages and journal articles. Barriers to PPI impact included geography, travel, funding, co-ordination and well-being. DISCUSSION: A future challenge for PPI impact will be the extent to which peer innovation (innovative PPI-led ideas) can be supported within research study delivery. PATIENT AND PUBLIC CONTRIBUTION: Planned Patient and Public Contribution in SlowMo comprised consultation and collaboration in (i) design, (ii) recruitment, (iii) qualitative interviews and analysis of service users' experiences of SlowMo therapy and (iv) dissemination.

A new Algorithm for Detecting Clinical High Risk of Psychosis in Adolescents / Un Nuevo Algoritmo para la Detección del Alto Riesgo Clínico de Psicosis en Adolescentes

Background: The delimitation of the clinical high risk of psychosis (CHRp) is characterized by the wide variety of symptoms assessed from different approaches from the onset of psychosis. This study aimed to create a systematic procedure for an effective and accurate earlydetection of CHRp in educational settings. Method: A representative sample of 1,824 adolescents (average age, 15.79; 53.8%, women) was used to develop an online assessment system and a new 3-track, 3-level algorithm that combines symptoms of the main risk approaches: ultra-high risk (UHR), basic symptoms (BS), and anomalies in the subjective self-experience (ASE) with functional deficit. Results: The acceptability and feasibility of the online screening system were confirmed by the data. Of the total participants, 68 (3.7%) were identified as high-risk and 417 (22.9%) were identified as moderate, which also supports the functionality of the proposed algorithm. Conclusions: The system indicates a dynamic model of progression of the different symptoms in the early stages of psychosis, and it may constitute a first line of identification for severe mental disorders in young people in the earliest stages, allowing application of initial preventive measures.(AU)

Antecedentes: La delimitación del alto riesgo clínico de psicosis (CHRp, por sus siglas en inglés) se caracteriza por la gran variedad de síntomas evaluados desde diferentes enfoques y la dificultad que existe para detectar los estadios clínicos más alejados del inicio de la psicosis. Este estudio tiene como objetivo la creación de un procedimiento sistemático para una detección temprana eficaz y precisa del CHRp en entornos educativos. Método: A partir de una muestra representativa de 1.824 adolescentes (edad, media= 15,79 años; 53,8%, mujeres) se ha desarrollado un sistema de evaluación online y un algoritmo de tres vías y tres niveles de riesgo que combina los síntomas de los principales enfoques de riesgo: ultra-alto riesgo (UHR), síntomas básicos (SB) y anomalías en la autoexperiencia subjetiva (ASE), además del déficit funcional. Resultados: A la luz de los datos obtenidos se han confirmado la aceptabilidad y viabilidad del sistema de cribado online. Del total de participantes, 68 (3,7%) fueron identificados como de alto riesgo y 417 (22,9%) como de riesgo moderado, lo que también avala la funcionalidad del algoritmo propuesto. Conclusiones: El sistema apoya la existencia de un modelo dinámico de progresión de los diferentes síntomas en las primeras etapas de la psicosis, y puede constituir una primera línea de identificación de los trastornos mentales graves en los jóvenes en las etapas más tempranas, de cara a la aplicación de las medidas preventivas iniciales.(AU)

Virtual reality-based assessment and treatment of social functioning impairments in psychosis: a systematic review.

People with psychosis can experience social functioning impairments. Virtual reality (VR) has been used to assess and treat these difficulties. This systematic review (Prospero CRD42015026288) provides an evaluation of these VR applications. PsycINFO, MEDLINE, Embase, Web of Science, Cochrane Library, and Scopus were searched until May 2020. The Effective Public Health Practice Project (EPHPP) Quality Assessment Tool was used to assess studies. Database searching identified 3810 titles. Fifty-eight studies (published 2005-2020; N = 2,853), comprising twenty-six head-mounted display studies (20 assessment, 6 treatment) and thirty-two immersive 2D screen studies (23 assessment, 9 treatment), were included. There were forty-eight observational studies and ten randomised controlled trials, with 1570 participants (of which, 185 were at ultra-high risk of psychosis) in VR test groups. Nearly half the studies were published since 2016. Assessments targeted cognitive and behavioural indicators of social functioning, e.g. paranoia, eye gaze, or interpersonal distance. Treatments promoted cognitive-behavioural social skills or job interview training. Studies indicate feasibility, acceptability, and effectiveness of VR for social functioning impairments in psychosis. Limitations of studies include the narrow scope of social functioning, small sample sizes, and limited randomised controlled trials and standardised interventions. Findings suggest VR has potential to be integrated with existing psychological approaches.

Relating behaviours and therapeutic actions during AVATAR therapy dialogue: An observational study.

OBJECTIVES: AVATAR therapy is a novel relational approach to working with distressing voices by engaging individuals in direct dialogue with a digital representation of their persecutory voice (the avatar). Critical to this approach is the avatar transition from abusive to conciliatory during the course of therapy. To date, no observational study has examined the moment-to-moment dialogical exchanges of this innovative therapy. We aim to (1) map relating behaviours between participants and their created avatars and (2) examine therapeutic actions delivered within AVATAR dialogue. METHOD: Twenty-five of the fifty-three AVATAR therapy completers were randomly selected from a randomized controlled trial (Craig et al. The Lancet Psychiatry, 5, 2018 and 31). Seventy-five audio recordings of active dialogue from sessions 1 and 4 and the last session were transcribed and analysed using a newly developed coding frame. Inter-rater reliability was good to excellent. RESULTS: Fine-grained analysis of 4,642 observations revealed nuanced communication around relational power and therapeutic activity. Early assertiveness work, reinforced by the therapist, focussed on increasing power and distancing. Participants' submissive behaviours reduced during therapy, but the shift was gradual. Once the transition to a more conciliatory tone took place, the dialogue primarily involved direct communication between participant and avatar, focussing on sense of self and developmental and relational understanding of voices. CONCLUSIONS: AVATAR therapy supports voice-hearers in becoming more assertive towards a digital representation of their abusive voice. Direct dialogue with carefully characterized avatars aims to build the voice-hearers' positive sense of self, supporting the person to make sense of their experiences. PRACTITIONER POINTS: AVATAR therapy enables voice-hearers to engage in face-to-face dialogue with a digital representation ('avatar') of their persecutory voice. Fine-grained analyses showed how relating behaviours and therapeutic actions evolve during active AVATAR therapy dialogue. Carefully characterized avatars and direct therapist input help voice-hearers become more assertive over the avatar, enhance positive sense of self, and support individuals to make sense of their experiences.

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).

Effects of SlowMo, a Blended Digital Therapy Targeting Reasoning, on Paranoia Among People With Psychosis: A Randomized Clinical Trial.

Importance: Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain. Objective: To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only. Design, Setting, and Participants: This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia. Interventions: Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181). Main Outcomes and Measures: The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task). Results: A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, -0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, -0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%). Conclusions and Relevance: SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo's effects is warranted. Trial Registration: isrctn.org Identifier: ISRCTN 32448671.

The role of characterisation in everyday voice engagement and AVATAR therapy dialogue.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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 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.

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets.

AVATAR therapy represents an effective new way of working with distressing voices based on face-to-face dialogue between the person and a digital representation (avatar) of their persecutory voice. To date, there has been no complete account of AVATAR therapy delivery. This article presents, for the first time, the full range of therapeutic targets along with information on acceptability and potential side effects. Interest in the approach is growing rapidly and this report acts as a necessary touchstone for future development.

Are we there yet?!-a literature review of recent digital technology advances for the treatment of early psychosis.

Access to psychological interventions during early stages of psychosis is essential for ameliorating outcomes and improving prognosis. However, reaching and engaging individuals at these stages of the illness can be very challenging for early intervention teams. Recent digital technological advances have emerged to overcome some of these challenges and to improve access to psychological interventions. The aim of the present literature review is to summarise main findings of relevant studies published during the last 10 years on the utilization of digital technologies (i.e., virtual reality, smartphone technology and web-based interventions) to enhance psychological treatment outcomes in early psychosis. A literature search from January 2009 to June 2019 was performed to identify relevant papers. Of 1,502 studies identified, nine met inclusion criteria for the review and only five presented results from finalised trials. Overall, these studies showed positive feasibility and acceptability results, along with preliminary evidence of improved therapy outcomes. The present review offers a state-of-the-art summary of the main features of these user-centered digital interventions for early stages of psychosis and a critical discussion about their future implementation in mental health services.

Subjective experience of paranoid ideation in a virtual reality social environment: A mixed methods cross-sectional study.

Virtual reality-assisted cognitive-behavioural therapy (VR-CBT) has potential to support people who experience paranoid ideation in social settings. However, virtual reality (VR) research using overt social environments is limited, and lack of qualitative studies on paranoid ideation in VR restricts understanding. This study aimed to use predominantly qualitative methods to investigate subjective experience of paranoia in VR and identify target domains for VR-CBT. Participants (N = 36) were non-clinical adults with high trait paranoia, who entered an interactive VR bar-room environment. After VR, they participated in brief audiotaped semi-structured interviews designed for measuring persecutory ideation in virtual environments. Researchers scored transcripts on the Comprehensive Assessment of At-Risk Mental States Non-Bizarre Ideas Global Rating Scale to rate the state paranoia represented by interview content. Thematic analysis of interviews employed superordinate themes of Social Evaluative Concerns, Ideas of Reference, and Ideas of Persecution to investigate participants' experience of paranoia. Mean score on the Non-Bizarre Ideas scale was 3.06 (standard deviation 1.24, range 1-6), indicating "moderate" attenuated-paranoid experiences. Nearly all participants reported Social Evaluative Concerns (N = 35) and Ideas of Reference (N = 32); half reported Ideas of Persecution (N = 19). Twelve subthemes were identified. Notably, participants believed they did not belong in the environment (N = 31), that they were the object of discussion (N = 20), and that they felt avatars were unfriendly (N = 27) and intentionally rejected them (N = 13). Subthemes reflect interpersonal and social processes that may constitute target areas for VR-CBT, for example, cognitive appraisals and social skills. Identification of these domains indicates how personalized VR-CBT may be operationalized.

Factors Affecting Sense of Presence in a Virtual Reality Social Environment: A Qualitative Study.

Sense of presence is an important factor influencing the quality of the virtual reality (VR) experience. However, there is limited understanding of what factors affect presence in virtual environments. This study uses a qualitative methodology, specifically thematic analysis, to investigate factors affecting sense of presence in a VR social environment that has been designed for psychological assessment. After experiencing a virtual bar-room that contained interactions with multiple avatars, participants (n = 76) took part in a semistructured interview. Eight key themes and associated subthemes were identified: emotions about self (anxiety, paranoid ideation, and detachment), emotions about others (loneliness, retrospective emotions, and recognition of self), thoughts about self (memories and social judgment), thoughts about others (paranoid ideation and narrative), physiological reactions (anxiety and cybersickness), behavior of avatars (narrative, duration of interaction, and characteristics), interactivity with environment (movement and familiarity), and environmental characteristics (restrictions). Sense of presence was facilitated when the VR elicited genuine cognitive, emotional, and behavioral responses, and when participants created their own narrative about events. Presence decreased when participants experienced diminished agency and experienced physical impediments, such as cybersickness and awareness of apparatus and body movement. Strengths of the study include rich data generated by the qualitative approach and the large sample size. Limitations include lack of follow-up measuring longer-term effects.