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Abstract Background Sleep problems are common in young people. Yet brief screening measures to identify those most in need of an intervention are lacking. This study investigated the potential of the two-item Sleep Condition Indicator (SCI-02) for screening insomnia symptoms in children and adolescents. We sought to establish whether there are distinct subgroups with different sleep profiles and whether subgroup membership varied with gender and school year group. Methods Students (school years 5–13; typical age 9–18 years) in England completed the OxWell Student Survey in 2021. Sleep measures included: SCI-02, sleep onset latency (SOL), sleep duration, daytime sleepiness, and worry disrupting sleep. Latent profile analysis and multinomial logistic regression explored sleep profiles and predicted class membership. Results In total, 29,304 participants answered sleep items. Of these, 95% provided binary gender (n = 27,802, 55% female) for analyses. Five sleep profiles emerged. The profiles, labelled “good”, “moderate”, or “poor” sleepers, vary by sleep quality – which includes time taken to fall asleep (SOL), amount of sleep (sleep duration), and the disruption of sleep due to worry. The profiles are then further differentiated by high levels of daytime sleepiness – labelled “sleepy”. “Good Sleepers” (18,355, 66%), “Moderate Sleepers” (4825, 17.4%), “Moderate Sleepy Sleepers” (1250, 4.5%), “Poor Sleepers” (1037, 3.7%) and “Poor Sleepy Sleepers” (2335, 8.4%). Probable insomnia rates (SCI-02 ≤ 2) were high in both poor sleeper profiles (70–80%) compared with other profiles (0%) and the sample overall (9%). Compared with “Good Sleepers”, all other profiles were mostly female. Daytime sleepiness – the defining characteristic of the sleepy sleeper profiles – was more common in secondary school participants than primary school. Conclusions The SCI-02 is an efficient, two-question measure to screen for potential sleep problems in young people. Sleep disruption was high: one in ten were experiencing poor sleep. Females and adolescents appeared more vulnerable to poor sleep and daytime sleepiness. The SCI-02 has the potential for use in school and community contexts to identify children and adolescents who may benefit from support managing their sleep.

Abstract Automated delivery of therapy in virtual reality (VR) has the potential to be used for smoking cessation. Most obviously, it could be used to practise and establish alternative reactions to smoking cues. The first step in treatment development is to show that VR environments can trigger sufficient cravings in smokers. We evaluated a new VR public house outdoor scenario with 100 individuals who smoked daily. Participants were randomly assigned to the VR scenario with smoking cues or a neutral experience in VR. The VR experiences were presented in a standalone VR headset. Before and after VR, we collected self-reported craving scores for cigarettes and alcohol using the Tobacco Craving Questionnaire (TCQ) and visual analogue scales (VAS). Physiological data were also collected. Compared to the neutral condition, exposure to the smoking cues led to a large increase in craving for a cigarette (TCQ β = 11.44, p

Background A persecutory delusion (severe paranoia) occurs when a person believes that others are trying to harm them when they are not. It is often a central difficulty for patients diagnosed with schizophrenia.Objective The objective is to identify potentially important research questions about severe paranoia.Methods A priority-setting partnership exercise was conducted involving people with lived experience, carers, mental health staff, and researchers. An initial survey identified research questions, and a second survey prioritised a refined list of questions. There was a project steering group.Findings 1480 responses were gathered from 146 people (56 people with lived experience, 23 family members, 78 mental health staff, and 21 researchers). Following refinement, 201 questions were rated by the steering group for priority to enter the second survey. 38 questions were rated in the second survey by 157 people (69 people with lived experience, 33 family members, 59 mental health staff, and 27 researchers). 15 questions were identified as research priorities, each endorsed to a largely similar extent across stakeholder groups. These covered a wide range of topics, including how to support family and carers, understanding the causes of paranoia, managing paranoid thoughts day-to-day, improving access to services, and developing psychological and pharmacological approaches.Conclusions There was a good deal of consensus in key questions—covering many aspects of understanding, treatment, and support—to be answered about severe paranoia. Most questions were considered largely equally important.Clinical implications Numerous questions were identified that, if addressed, might improve clinical provision for persecutory delusions.

AbstractVirtual reality (VR) is an immersive technology in which delivery of psychological therapy techniques can be automated. Techniques can be implemented similarly to real-world delivery or in ways that are not possible in the real world to enhance efficacy. The potential is for greater access for patients to effective therapy. Despite an increase in the use of VR for mental health, there are few descriptions of how to build and design automated VR therapies. We describe the development of Phoenix VR Self-Confidence Therapy, designed to increase positive self-beliefs in young patients diagnosed with psychosis in order to improve psychological well-being. A double-diamond, user-centered design process conducted over the course of 18 months was used, involving stakeholders from multiple areas: individuals with lived experience of psychosis, clinical psychologists, treatment designers, and VR software developers. Thirteen meetings were held with young patients diagnosed with psychosis to increase the understanding and improve the assessment of positive self-beliefs, help design the scenarios for implementing therapeutic techniques, and conduct user testing. The resulting Phoenix therapy is a class I United Kingdom Conformity Assessed (UKCA)–certified medical device designed to be used on the standalone Meta Quest 2 (Meta Platforms) headset. Phoenix aims to build up 3 types of positive self-beliefs that are connected to psychological well-being. In a community farm area, tasks are designed to increase a sense of mastery and achievement (“I can make a difference”); in a TV studio, users complete an activity with graded levels of difficulty to promote success in the face of a challenge (“I can do this”); and in a forest by a lake, activities are designed to encourage feelings of pleasure and enjoyment (“I can enjoy things”). Phoenix is delivered over the course of approximately 6 weekly sessions supported by a mental health provider. Patients can take the headsets home to use in between sessions. Usability testing with individuals with lived experience of psychosis, as well as patients in the National Health Service (aged 16‐26 years), demonstrated that Phoenix is engaging, easy to use, and has high levels of satisfaction.

Background Patients diagnosed with psychosis often spend less time than others engaged in exercise and more time sitting down, which likely contributes to poorer physical and mental health.Objective The aim of this study was to develop a comprehensive framework from the perspective of patients, carers, and staff for understanding what promotes movement and physical activity.Methods A critical realist approach was taken to design the study. Interviews (n=23) and focus groups (n=12) were conducted with (1) outpatients aged 16 years or older diagnosed with psychosis, and under the care of a mental health team, (2) carers and (3) mental health staff working in the community. Purposive sampling was used to maximise variation in participant characteristics. Data were analysed using reflexive thematic analysis.Findings 19 patients (9 women and 10 men, mean age=45·0 (SD=12·2) years, 15 White British, 2 Black African, 1 Pakistani and 1 other ethnic group), 14 carers (11 women and 3 men, mean age=59·9 (SD=12·7) years, 13 White British and 1 Asian) and 18 staff (14 women and 4 men, mean age=38·7 (SD=12·3) years, 15 White British, 1 White other, 1 Asian Bangladeshi and 1 other Asian) participated in the study. Five factors were found to promote movement and physical activity. Patients must be able to find a purpose to moving which is meaningful to them (Factor 1: Purpose). Patients need to have an expectation of the positive consequences of movement and physical activity, which can be influenced by others’ expectations (Factor 2: Predictions). A patient’s current physical (eg, pain) and emotional state (eg, distress about voices) needs to be addressed to allow movement and physical activity (Factor 3: Present state). Movement and physical activity can also be encouraged by the availability of effective and tailored support, provided by engaged and supported people (Factor 4: Provision). Finally, through the identification and interruption of vicious cycles (eg, between inactivity and mood states) more positive cycles can be put in place (Factor 5: Process).Conclusions and clinical implications The 5 P (Purpose, Predictions, Present state, Provision and Process Physical Activity Framework) for understanding movement and physical activity for people diagnosed with psychosis has the potential to inform future research and guide interventions. A checklist is provided for clinicians to help foster change in activity levels.

Abstract Background Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp). Methods A single-blind parallel-group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include the severity of the persecutory delusion, general paranoid ideation, patient-chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation. Discussion The Feeling Safe-NL Trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and a CBT-based program for recovery from persecutory delusions. Trial registration Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).

Abstract Background The rates of obesity and associated health problems are higher in people with serious mental illness (SMI), such as schizophrenia and bipolar disorder, than the general population. A primary care referral to a behavioural weight management programme can be an effective intervention, but people with SMI have reported barriers to engaging with them and bespoke options are rarely provided in routine practice. It is possible that adjunct support addressing these specific barriers could help. Here we report the development, feasibility and acceptability of an intervention to improve uptake and engagement with a mainstream weight management programme for people with SMI. Methods We worked with people with a lived-experience of SMI and used the person-based approach to develop the ‘Weight cHange for people with sErious mEntal iLlness’ (WHEEL) intervention. It comprised a referral to a mainstream weight management programme (WW®) to be attended once a week, in-person or online, for 12-weeks. The adjunct support comprised a one-off, online consultation called Meet Your Mentor and weekly, telephone or email Mentor Check Ins for 12-weeks. We assessed the feasibility of WHEEL through the number of programme and adjunct support sessions that the participants attended. We analysed the acceptability of WHEEL using a thematic analysis of qualitative interviews conducted at baseline and at 12-week follow-up. Our exploratory outcome of clinical effectiveness was self-reported weight at baseline and at end-of-programme. Results Twenty participants were assessed for eligibility and 17 enrolled. All 17 participants attended Meet Your Mentor and one was lost to follow-up (94% retention). Nine out of 16 attended ≥50% of the weekly programme sessions and 12/16 attended ≥50% of the weekly check-ins. Participants reported in the interviews that the adjunct support helped to establish and maintain a therapeutic alliance. While some participants valued the in-person sessions, others reported that they preferred the online sessions because it removed a fear of social situations, which was a barrier for some participants. The mean change in self-reported weight was − 4·1 kg (SD: 3·2) at 12-weeks. Conclusions A mainstream weight management programme augmented with brief and targeted education and low-intensity check-ins generated sufficient engagement and acceptability to warrant a future trial.

BackgroundAutomated virtual reality (VR) therapy has the potential to substantially increase access to evidence-based psychological treatments. The results of a multicenter randomized controlled trial showed that gameChange VR cognitive therapy reduces the agoraphobic avoidance of people diagnosed with psychosis, especially for those with severe avoidance. ObjectiveWe set out to use a peer research approach to explore participants’ experiences with gameChange VR therapy. This in-depth experiential exploration of user experience may inform the implementation in clinical services and future VR therapy development. MethodsPeer-led semistructured remote interviews were conducted with 20 people with a diagnosis of psychosis who had received gameChange as part of the clinical trial (ISRCTN17308399). Data were analyzed using interpretative phenomenological analysis and template analyses. A multiperspectival approach was taken to explore subgroups. Credibility checks were conducted with the study Lived Experience Advisory Panel. ResultsParticipants reported the substantial impact of anxious avoidance on their lives before the VR intervention, leaving some of them housebound and isolated. Those who were struggling the most with agoraphobic avoidance expressed the most appreciation for, and gains from, the gameChange therapy. The VR scenarios provided “a place to practise.” Immersion within the VR scenarios triggered anxiety, yet participants were able to observe this and respond in different ways than usual. The “security of knowing the VR scenarios are not real” created a safe place to learn about fears. The “balance of safety and anxiety” could be calibrated to the individual. The new learning made in VR was “taken into the real world” through practice and distilling key messages with support from the delivery staff member. ConclusionsAutomated VR can provide a therapeutic simulation that allows people diagnosed with psychosis to learn and embed new ways of responding to the situations that challenge them. An important process in anxiety reduction is enabling the presentation of stimuli that induce the original anxious fears yet allow for learning of safety. In gameChange, the interaction of anxiety and safety could be calibrated to provide a safe place to learn about fears and build confidence. This navigation of therapeutic learning can be successfully managed by patients themselves in an automated therapy, with staff support, that provides users with personalized control. The clinical improvements for people with severe anxious avoidance, the positive experience of VR, and the maintenance of a sense of control are likely to facilitate implementation.

BackgroundAn automated virtual reality cognitive therapy (gameChange) has demonstrated its effectiveness to treat agoraphobia in patients with psychosis, especially for high or severe anxious avoidance. Its economic value to the health care system is not yet established. ObjectiveIn this study, we aimed to estimate the potential economic value of gameChange for the UK National Health Service (NHS) and establish the maximum cost-effective price per patient. MethodsUsing data from a randomized controlled trial with 346 patients with psychosis (ISRCTN17308399), we estimated differences in health-related quality of life, health and social care costs, and wider societal costs for patients receiving virtual reality therapy in addition to treatment as usual compared with treatment as usual alone. The maximum cost-effective prices of gameChange were calculated based on UK cost-effectiveness thresholds. The sensitivity of the results to analytical assumptions was tested. ResultsPatients allocated to gameChange reported higher quality-adjusted life years (0.008 QALYs, 95% CI –0.010 to 0.026) and lower NHS and social care costs (–£105, 95% CI –£1135 to £924) compared with treatment as usual (£1=US $1.28); however, these differences were not statistically significant. gameChange was estimated to be worth up to £341 per patient from an NHS and social care (NHS and personal social services) perspective or £1967 per patient from a wider societal perspective. In patients with high or severe anxious avoidance, maximum cost-effective prices rose to £877 and £3073 per patient from an NHS and personal social services perspective and societal perspective, respectively. ConclusionsgameChange is a promising, cost-effective intervention for the UK NHS and is particularly valuable for patients with high or severe anxious avoidance. This presents an opportunity to expand cost-effective psychological treatment coverage for a population with significant health needs. Trial RegistrationISRCTN Registry ISRCTN17308399; https://www.isrctn.com/ISRCTN17308399 International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2019-031606

BackgroundAutomated virtual reality (VR) therapy could allow a greater number of patients to receive evidence-based psychological therapy. The aim of the gameChange VR therapy is to help patients overcome anxious avoidance of everyday social situations. gameChange has been evaluated with outpatients, but it may also help inpatients prepare for discharge from psychiatric hospital. ObjectiveThe aim of this study is to explore the views of patients and staff on the provision of VR therapy on psychiatric wards. MethodsFocus groups or individual interviews were conducted with patients (n=19) and National Health Service staff (n=22) in acute psychiatric wards. Questions were derived from the nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability framework. Expectations of VR therapy were discussed, and participants were then given the opportunity to try out the gameChange VR therapy before they were asked questions that focused on opinions about the therapy and feasibility of adoption. ResultsThere was great enthusiasm for the use of gameChange VR therapy on psychiatric wards. It was considered that gameChange could help build confidence, reduce anxiety, and “bridge that gap” between the differences of being in hospital and being discharged to the community. However, it was reflected that the VR therapy may not suit everyone, especially if they are acutely unwell. VR on hospital wards for entertainment and relaxation was also viewed positively. Participants were particularly impressed by the immersive quality of gameChange and the virtual coach. It was considered that a range of staff groups could support VR therapy delivery. The staff thought that implementation would be facilitated by having a lead staff member, having ongoing training accessible, and involving the multidisciplinary team in decision-making for VR therapy use. The most significant barrier to implementation identified by patients and staff was a practical one: access to sufficient, private space to provide the therapy. ConclusionsPatients and staff were keen for VR to be used on psychiatric wards. In general, patients and staff viewed automated VR therapy as possible to implement within current care provision, with few significant barriers other than constraints of space. Patients and staff thought of many further uses of VR on psychiatric wards. The value of VR therapy on psychiatric wards now requires systematic evaluation. International Registered Report Identifier (IRRID)RR2-10.2196/20300

Abstract Purpose The aim of this work was to develop a mapping algorithm for estimating EuroQoL 5 Dimension (EQ-5D) utilities from responses to the Long-Term Conditions Questionnaire (LTCQ), thus increasing LTCQ’s potential as a comprehensive outcome measure for evaluating integrated care initiatives. Methods We combined data from three studies to give a total sample of 1334 responses. In each of the three datasets, we randomly selected 75% of the sample and combined the selected random samples to generate the estimation dataset, which consisted of 1001 patients. The unselected 25% observations from each dataset were combined to generate an internal validation dataset of 333 patients. We used direct mapping models by regressing responses to the LTCQ-8 directly onto EQ-5D-5L and EQ-5D-3L utilities as well as response (or indirect) mapping to predict the response level that patients selected for each of the five EQ-5D-5L domains. Several models were proposed and compared on mean squared error and mean absolute error. Results A two-part model with OLS was the best performing based on the mean squared error (0.038) and mean absolute error (0.147) when estimating the EQ-5D-5L utilities. A multinomial response mapping model using LTCQ-8 responses was used to predict EQ-5D-5L responses levels. Conclusions This study provides a mapping algorithm for estimating EQ-5D utilities from LTCQ responses. The results from this study can help broaden the applicability of the LTCQ by producing utility values for use in economic analyses.

Abstract Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p =

The speed of COVID-19 vaccine development has been identified as a central concern contributing to hesitancy in acceptance. We conducted qualitative interviews to gain a greater understanding into these concerns and to identify what might address them. Twelve qualitative interviews were conducted with participants identifying as hesitant for COVID-19 vaccination and reporting concern about the speed of vaccine development. Interpretative Phenomenological Analysis (IPA) was used. Concerns about speed comprised the linked themes of i) difficulty understanding the pace, and, ii) worry about the implications for vaccine safety. Uncertainties concerning the pandemic led to a notable desire for credible and understandable information regarding the vaccines, which many participants felt was not available. Four routes to resolving uncertainty about whether to be vaccinated were identified. First, waiting for more information about the vaccines, such as about their contents and impact on transmission. Second, a growing perception that the vaccines must be safe given the large numbers already vaccinated. Third, viewing the vaccines as necessary – even if unappealing – for ending the pandemic. Finally, a feeling that there would be no choice but to have a vaccine. Examples of what might reduce hesitancy were given, including interviews with vaccine developers and knowing others of similar age having safely been vaccinated. The pace of development broke expectations set earlier in the pandemic. This was interpreted negatively due to a perceived lack of credible information. Most participants could envisage ways their concerns could be resolved, enough for them to have a vaccine.

Introduction People with serious mental illness (SMI), which includes people with diagnoses of schizophrenia spectrum and bipolar disorders, face significant health inequality. This includes a life expectancy reduced by 15–20 years mostly due to premature cardiovascular disease (CVD) compared with the general population. Excess weight gain and related comorbidities are preventable risk factors for CVD. To improve the understanding and management of CVD in people with SMI, we will examine the association between SMI and: (1) weight change; (2) cardio-metabolic risk factors for CVD; and (3) incidence of and mortality from CVD. We will also (4) examine the incidence of referral to weight management services for people with SMI compared with people without SMI.Methods and analysis In this retrospective cohort study, we will link general practice records from the UK Clinical Practice Research Datalink Aurum database. We will establish a cohort of patients diagnosed with SMI between 1998 and 2020 who are matched with up to four controls on age, sex, general practice and calendar year. We will use multivariable mixed-effects linear regression models and Cox proportional hazard models with sequential adjustment for potential confounders identified by separate directed acyclic graphs.Ethics and dissemination This study has been reviewed and approved by the Independent Scientific Advisory Committee for Medicines and Healthcare products Regulatory Agency database research. The results will be published in a peer-reviewed journal.

BackgroundMany people with psychosis experience difficulties in everyday social situations. Anxiety can make life challenging, leading to withdrawal. Cognitive therapy, using active in vivo learning, enables people to overcome fears. These treatments are not readily available to people with psychosis. Automated virtual reality (VR) therapy is a potential route to increase accessibility. The gameChange automated VR cognitive therapy is designed to help people overcome anxious avoidance and build confidence in everyday social situations. A virtual coach guides the person through the treatment. Understanding user experience is key to facilitating future implementation. Peer research methods, in which people with lived experience of the issues being studied are involved in collecting and analyzing data, may be useful in developing this understanding. This encourages researchers to draw on their lived experience to explore participant perspectives and co-create knowledge. ObjectiveThe primary objective is to use a peer research approach to explore the participant experience of a novel automated VR therapy for anxious social avoidance. This includes understanding (1) the experience of anxious social avoidance in people with psychosis, (2) the experience of the gameChange automated VR cognitive therapy, and (3) any potential impact of the therapy in people’s lives. This will inform future implementation strategies. The secondary objective is to explore how peer research can be used to co-create knowledge. MethodsSemistructured interviews will be conducted with approximately 25 people with psychosis participating in the gameChange trial (ISRCTN17308399). Participants will be recruited from the five trial centers based in National Health Service mental health trusts across England. Interviews will be conducted by two researchers. One is a peer researcher with similar lived experience to the trial participants. The other has lived experiences of mental health issues that do not directly overlap with those of the trial participants. Interview questions will focus on an individual’s experience of anxious social avoidance, experiences of participating in the gameChange VR therapy, and any changes or impact following therapy. The interview schedule was developed in collaboration with the gameChange Lived Experience Advisory Panel (LEAP), comprising 10 project advisors with lived experience of psychosis. Interpretative phenomenological analysis and template analysis will be used to explore individual accounts. The LEAP will contribute to the analysis. ResultsData collection will be conducted from April to September 2021, and analysis will be conducted from June to October 2021. As of September 28, 2021, 20 participants had been interviewed, and coding is underway. ConclusionsThe study, employing a peer research approach, may provide a unique insight into the experiences of anxious social avoidance in people with psychosis and its treatment using automated VR therapy. This will inform potential future implementation of VR automated therapies in mental health services. International Registered Report Identifier (IRRID)DERR1-10.2196/31742

Background: To determine the prevalence of suicidal ideation and behaviour - and their correlates - in patients with persecutory delusions. Methods: 110 patients with persecutory delusions in the context of non-affective psychosis were assessed for suicidal thoughts and behaviours over the past month. Symptom and psychological assessments were also completed. Results: The severity of suicidal ideation was: no suicidal ideation (n = 26, 23.6%); wish to be dead (n = 21, 19.1%); nonspecific active suicidal thoughts (n = 14, 12.7%); suicidal thoughts with methods but no intent (n = 29, 26.4%); suicidal thoughts with intent but no specific plan (n = 13, 11.8%); and suicidal intent with plan (n = 7, 6.4%). In the past month, five patients (4.5%) had made an actual, interrupted, or aborted suicide attempt. The severity of suicidal ideation was associated with higher levels of depression, paranoia, hallucinations, anger, insomnia, negative beliefs about the self and others, pessimism, worry, and delusion safety-seeking behaviours and lower levels of psychological well-being and reward responsiveness. Severity of ideation was not associated with cannabis or alcohol use, working memory, pain, or meaningful activity levels. Conclusions: Patients with persecutory delusions are typically in a severe state of psychological stress, and at risk of suicide, as indicated by very high levels of suicidal ideation. This exploratory study also identifies correlates of suicidal ideation that could be investigated in causal research designs. Keywords: Suicide, Persecutory delusions, Schizophrenia, Depression

Abstract Background Persecutory delusions are a major psychiatric problem and are associated with a wide range of adverse outcomes. Our theoretical model views these delusions as unfounded threat beliefs which persist due to defence behaviours (e.g. avoidance) that prevent disconfirmatory evidence being processed. The treatment implications are that patients need to (1) go into feared situations and (2) not use defence behaviours. This enables relearning of safety and hence paranoia diminution. However, this is very difficult for patients due to their severe anxiety. A solution is to use virtual reality (VR) social situations, which are graded in difficulty and which patients find much easier to enter. We have now automated the provision of cognitive therapy within VR using an avatar coach, so that a therapist is not required and the treatment is scalable. In the THRIVE trial, the automated VR cognitive treatment will be tested against a VR control condition. It will contribute to our wider programme of work developing VR for patients with psychosis. Methods Patients with persistent persecutory delusions in the context of non-affective psychosis will be randomised (1:1) to the automated VR cognitive treatment or VR mental relaxation (control condition). Each VR treatment will comprise approximately four sessions of 30 min. Standard care will remain as usual in both groups. Assessments will be carried out at 0, 2, 4 (post treatment), 8, 16, and 24 weeks by a researcher blind to treatment allocation. The primary outcome is degree of conviction in the persecutory delusion (primary endpoint 4 weeks). Effect sizes will be re-established by an interim analysis of 30 patients. If the interim effect size suggests that the treatment is worth pursuing (d > 0.1), then the trial will go on to test 90 patients in total. Secondary outcomes include real world distress, activity levels, suicidal ideation, and quality of life. Mediation will also be tested. All main analyses will follow the intention-to-treat principle. The trial is funded by the Medical Research Council Developmental Pathway Funding Scheme. Discussion The trial will provide the first test of automated cognitive therapy within VR for patients with psychosis. The treatment is potentially highly scalable for treatment services. Trial registration ISRCTN, ISRCTN12497310. Registered on 14 August 2018.

Summary: Background: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. Methods: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7–35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. Findings: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference –1·49, 95% CI –2·16 to –0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (−0·91, –1·58 to –0·23; adjusted p=0·0261), and a combination of all information (−0·86, –1·53 to –0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (−0·97, 95% CI –1·64 to –0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (−1·01, –1·68 to –0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes. Interpretation: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.

We explore the implications of online social endorsement for the Covid-19 vaccination program in the United Kingdom. Vaccine hesitancy is a long-standing problem, but it has assumed great urgency due to the pandemic. By early 2021, the United Kingdom had the world’s highest Covid-19 mortality per million of population. Our survey of a nationally representative sample of UK adults ( N = 5,114) measured socio-demographics, social and political attitudes, media diet for getting news about Covid-19, and intention to use social media and personal messaging apps to encourage or discourage vaccination against Covid-19. Cluster analysis identified six distinct media diet groups: news avoiders, mainstream/official news samplers, super seekers, omnivores, the social media dependent, and the TV dependent. We assessed whether these media diets, together with key attitudes, including Covid-19 vaccine hesitancy, conspiracy mentality, and the news-finds-me attitude (meaning giving less priority to active monitoring of news and relying more on one’s online networks of friends for information), predict the intention to encourage or discourage vaccination. Overall, super-seeker and omnivorous media diets are more likely than other media diets to be associated with the online encouragement of vaccination. Combinations of (a) news avoidance and high levels of the news-finds-me attitude and (b) social media dependence and high levels of conspiracy mentality are most likely to be associated with online discouragement of vaccination. In the direct statistical model, a TV-dependent media diet is more likely to be associated with online discouragement of vaccination, but the moderation model shows that a TV-dependent diet most strongly attenuates the relationship between vaccine hesitancy and discouraging vaccination. Our findings support public health communication based on four main methods. First, direct contact, through the post, workplace, or community structures, and through phone counseling via local health services, could reach the news avoiders. Second, TV public information advertisements should point to authoritative information sources, such as National Health Service (NHS) and other public health websites, which should then feature clear and simple ways for people to share material among their online social networks. Third, informative social media campaigns will provide super seekers with good resources to share, while also encouraging the social media dependent to browse away from social media platforms and visit reliable and authoritative online sources. Fourth, social media companies should expand and intensify their removal of vaccine disinformation and anti-vax accounts, and such efforts should be monitored by well-resourced, independent organizations.

Background Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysis A randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and dissemination The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration number ISRCTN85601537.

BackgroundSleep problems are pervasive in people with schizophrenia, but there are no clinical guidelines for their treatment. The Better Sleep Trial (BEST) concluded that suitably adapted cognitive–behavioural therapy (CBT) is likely to be highly effective, although its cost-effectiveness is unknown.AimsTo assess the potential cost-effectiveness of CBT for sleep disorders in patients with schizophrenia.MethodAn economic evaluation of the BEST study with a 6-month time horizon was used to establish the cost-effectiveness of CBT plus usual care in terms of costs per quality-adjusted life year (QALY) gained. Uncertainty was displayed on cost-effectiveness planes and acceptability curves. Value of information analysis was performed to estimate the benefits of obtaining further evidence.ResultsOn average, the treatment led to a 0.035 QALY gain (95% CI −0.016 to 0.084), and £1524 (95% CI −10 529 to 4736) and £1227 (95% CI −10 395 to 5361) lower costs from National Health Service and societal perspectives, respectively. The estimated value of collecting more information about the effects of the CBT on costs and QALYs was approximately £87 million.ConclusionsCBT for insomnia in people with schizophrenia is effective and potentially cost-effective. A larger trial is needed to provide clear evidence about its cost-effectiveness.RelevancePatients with schizophrenia have multiple complex health needs, as well as very high rates of depression, suicidal ideation and poor physical health. The results of this study showed that treating pervasive sleep problems in this patient group with cognitive–behavioural therapy (CBT) is very likely to improve patient quality of life in the short term. Clinicians most commonly use hypnotic medication to treat sleeping disorders. This study indicates that CBT may be an effective and cost-effective intervention in this patient group. This alternative would also be aligned with patient preferences for psychological and behavioural-type therapy.Declaration of interestNone.

BackgroundThere are high rates of obesity and low self-esteem in patients with psychosis. The occurrence of negative voice content directly about appearance is therefore plausible. Derogatory comments about appearance are likely to be distressing, increase depression and contribute to social withdrawal.AimsTo systematically assess the occurrence of voice content regarding appearance and identify correlates.MethodSixty patients experiencing verbal auditory hallucinations at least once a week in the context of non-affective psychosis completed a measure assessing positive and negative voice content about appearance. They also completed assessments about body image, self-esteem, psychiatric symptoms and well-being.ResultsFifty-five (91.7%) participants reported hearing voices comment on their appearance. A total of 54 (90%) patients reported negative voice content about their appearance with 30 (50%) patients experienced negative appearance comments on a daily basis. The most common negative comment was ‘the voices tell me that I am ugly’ (n = 48, 80%). There were 39 (65%) patients who reported positive voice content on appearance. The most frequent positive comment was ‘I look as nice as other people’ (n = 26, 43.3%). Negative voice content about appearance was associated with body image concerns, paranoia, voice hearing severity, depression, worry, negative self-beliefs and safety-seeking behaviours. Positive appearance voice content was associated with greater body esteem and well-being and lower levels of depression and insomnia.ConclusionsVoice content about appearance is very common for patients seen in clinical services. Negative voice content may reflect – and subsequently reinforce – negative beliefs about one's appearance, low self-esteem, worry and paranoia.Declaration of interestNone.

BackgroundThe period before the formation of a persecutory delusion may provide causal insights. Patient accounts are invaluable in informing this understanding.AimsTo inform the understanding of delusion formation, we asked patients about the occurrence of potential causal factors – identified from a cognitive model – before delusion onset.MethodA total of 100 patients with persecutory delusions completed a checklist about their subjective experiences in the weeks before belief onset. The checklist included items concerning worry, images, low self-esteem, poor sleep, mood dysregulation, dissociation, manic-type symptoms, aberrant salience, hallucinations, substance use and stressors. Time to reach certainty in the delusion was also assessed.ResultsMost commonly it took patients several months to reach delusion certainty (n = 30), although other patients took a few weeks (n = 24), years (n = 21), knew instantly (n = 17) or took a few days (n = 6). The most frequent experiences occurring before delusion onset were: low self-confidence (n = 84); excessive worry (n = 80); not feeling like normal self (n = 77); difficulties concentrating (n = 77); going over problems again and again (n = 75); being very negative about the self (n = 75); images of bad things happening (n = 75); and sleep problems (n = 75). The average number of experiences occurring was high (mean 23.5, s.d. = 8.7). The experiences clustered into six main types, with patients reporting an average of 5.4 (s.d. = 1.0) different types.ConclusionsPatients report numerous different experiences in the period before full persecutory delusion onset that could be contributory causal factors, consistent with a complex multifactorial view of delusion occurrence. This study, however, relied on retrospective self-report and could not determine causality.Declaration of interestNone.

Introduction Many patients with psychosis experience everyday social situations as anxiety-provoking. The fears can arise, for example, from paranoia, hallucinations, social anxiety or negative-self beliefs. The fears lead patients to withdraw from activities, and this isolation leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment directly in the troubling situations so that patients learn that they can safely and confidently enter them. However patients with psychosis seldom receive such life-changing interventions. To solve this problem we have developed an automated psychological treatment delivered in virtual reality (VR). It allows patients to experience computer simulations of the situations that they find anxiety-provoking. A virtual coach guides patients, using cognitive techniques, in how to overcome their fears. Patients are willing to enter VR simulations of anxiety-provoking situations because they know the simulations are not real, but the learning made transfers to the real world.Methods and analysis 432 patients with psychosis and anxious avoidance of social situations will be recruited from National Health Service (NHS) secondary care services. In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone. Assessments will be conducted at 0, 6 (post-treatment) and 26 weeks by a researcher blind to allocation. The primary outcome is avoidance and distress in real-life situations, using a behavioural assessment task, at 6 weeks. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention-to-treat. Moderation and mediation will be tested. An economic evaluation will be conducted.Ethics and dissemination The trial has received ethical approval from the NHS South Central - Oxford B Research Ethics Committee (19/SC/0075). A key output will be a high-quality automated VR treatment for patients to overcome anxious avoidance of social situations.Trial registration number ISRCTN17308399.

We view sleep disruption as a contributory causal factor in the development of psychotic experiences. Clinical trials indicate that psychological interventions targeting insomnia result in improvements in both sleep and psychotic experiences. The aim of this study was to gain the perspective of young people at ultra-high risk of psychosis on their sleep problems and associated psychological treatment. Interviews were conducted with 11 patients, aged 15–22 years, at ultra-high risk of psychosis who had received a psychological sleep intervention. Responses were analyzed using thematic analysis. Disrupted sleep timing and a lack of routine were the characteristic hallmarks of participants' sleep problems. Sleep disturbance, psychological wellbeing, and functioning had a reciprocal relationship. There were negative expectations prior to therapy, however meaningful improvements occurred in sleep, mood, and functioning. The active implementation of therapy techniques was highlighted as important. These findings indicate that the treatment of sleep problems is highly valued and has a meaningful impact on wellbeing in young people at ultra-high risk of psychosis.