Insomnia symptoms in children and adolescents: screening for sleep problems with the two-item Sleep Condition Indicator (SCI-02).

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.

Supporting movement and physical activity in people with psychosis: A qualitative exploration of the carer perspective.

BACKGROUND: The need to increase exercise and decrease sedentary behaviour in people diagnosed with psychosis is well-recognised. AIMS: We set out to explore caregivers' perspectives on what supports and prevents physical activity, and how to use carers' support most effectively. METHOD: Fourteen caregivers of people diagnosed with psychosis were interviewed. Data were analysed using reflexive thematic analysis, in collaboration with caregivers. RESULTS: Four themes were developed, the first flagging the importance of physical activity, then the others calling for action: (a) Physical inactivity matters: carers are keen to support efforts to increase physical activity in their family or friends because of the enormous impact physical inactivity has on patients, and consequently on carers themselves, such as social isolation and reduction in their own activity. (b) Tell us: without being well-informed about how to help, carers can feel like they are powerless to stop a 'slow suicide' or 'decline' in patients. (c) Listen to us: through knowing their family and friends well, carers are able to identify important changes in patients and identify successful motivators for them, but these insights can feel uninvited. (d) Ask us: being invited to support activity as a partner in a patients' care is desirable but having offers of help rejected can "demotivate the motivator." CONCLUSIONS: Caregivers described strong motivation to help patients to be more physically active but can feel that their support is overlooked and under-used by services. Clinical recommendations for carer involvement in physical activity interventions are offered.

Developing an Automated Virtual Reality Therapy for Improving Positive Self-Beliefs and Psychological Well-Being (Phoenix VR Self-Confidence Therapy): Tutorial.

Unlabelled: Virtual 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.

A randomized controlled experiment testing the use of virtual reality to trigger cigarette craving in people who smoke.

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 ß = 11.44, p < 0.0001, Cohen's d = 1.10) and also a moderate increase in craving for alcohol ( ß = 0.7 , p = 0.017 , d = 0.50 ) . There were no significant physiological differences between the two conditions. These results provide good evidence that VR experiences can elicit strong craving for cigarettes. The programming can be part of developing a new VR cognitive therapy to help people reduce smoking.

Experiences of Help-Seeking for Severe Mental Health Problems in Young Pakistani Women: A Preliminary Qualitative Study.

Almost three quarters of mental illnesses start by the age of 25, yet youth (18-25-year-olds) are often underrepresented in U.K. services. This is particularly true for those of ethnic minorities. In this study, we aimed to understand how young Pakistani women and their parents make decisions to seek help for severe mental health problems, and the barriers and facilitators to accessing professional help. Young Pakistani women with experience of severe mental health problems and their parents were recruited from a community sample. Semi-structured interviews were conducted with six young people and two parents. Data were analyzed using reflexive thematic analysis. Pakistani culture and its interplay with British culture strongly influenced the decisions and ability of young Pakistani women and their parents to help-seek, largely through the role of stigma. Low mental health literacy, stigma, and a lack of culturally informed services were identified as the most common barriers to accessing care. These barriers fed into the internalized stigma these young women experienced which, through fear of damaged reputation and personal prejudices, posed further barriers to seeking help. Participants highlighted recommendations for both individual-level (e.g., increased education and awareness) and service-level (e.g., greater choice over care) change to facilitate accessibility of professional help. Young Pakistani women face multiple culturally related challenges to accessing care for severe mental health problems at both the individual- and service-level. Novel suggestions to address these challenges, such as including youth peer support workers in services, may facilitate more inclusive and accessible services.

The experience of seeking and accessing help from mental health services among young people of Eastern European backgrounds: A qualitative interview study.

OBJECTIVES: Most lifetime mental health problems (MHP) start before the age of 25. Yet young people-particularly those of minority backgrounds-often do not seek or access professional help. In the UK, young people of Eastern European (EE) backgrounds represent a large minority group; however, little is known about their experiences of MHP and help-seeking. In this study, we aim to understand the help-seeking process from the perspectives of EE young people. DESIGN: We used a qualitative study design with semi-structured individual interviews. The results were analysed using reflexive thematic analysis. METHOD: Twelve young people (18-25 years) of EE backgrounds, living in Oxfordshire, UK, took part. All participants had experienced a severe MHP and were identified in the community. RESULTS: EE young people's experiences of MHP and help-seeking were driven by a sense of being caught between different cultures and simultaneously needing to navigate the potentially contrasting expectations of both cultures. This process was reinforced or tempered by the perceived continuing influence of young people's families, that is, families with more open views about MHP made it easier for young people to navigate through the process of help-seeking. Young people's internalised cultural and familial beliefs about MHP affected their decision-making when experiencing difficulties, their levels of trust in services, and perceived sense of resourcefulness and ability to cope. CONCLUSIONS: Recognising and responding to the cultural tension that young people of EE backgrounds may experience can help us to develop more accessible and inclusive mental health services.

Structural barriers to help-seeking in first-episode psychosis: A systematic review and thematic synthesis.

AIM: Access to timely treatment is key to early intervention in psychosis. Despite this, barriers to treatment exist. In this review, we aimed to understand the structural barriers that patients and caregivers face in help-seeking for first-episode psychosis, and the recommendations provided to address these. METHODS: We conducted a systematic review (PROSPERO: CRD42021274609) of qualitative studies reporting structural barriers to help-seeking from the patient or caregiver perspective. Searches were performed in September 2023, restricted to studies published from 2001. Study quality was appraised using Critical Appraisal Skills Programme. Data were analysed using thematic synthesis. RESULTS: Nineteen papers from 11 countries were included. Across all papers, participants reported experiencing structural barriers to receiving healthcare. For many patients and caregivers, the process of accessing healthcare is complex. Access requires knowledge and resources from parents, caregivers and healthcare providers, yet too often there is a misalignment between patients' needs and service resources. Expertise amongst healthcare providers vary and some patients and caregivers experience negative encounters in healthcare. Patients highlighted earlier caregiver involvement and greater peer support as potential routes for improvement. CONCLUSION: Patients and caregivers face multiple structural barriers, with legislative practices that discourage family involvement, and healthcare and transport costs found to be particularly problematic. Understanding these barriers can facilitate the co-design of both new and existing services to provide easier access for patients and caregivers. Further research is needed focusing not only on the perspectives of patients and caregivers who have accessed professional help but also crucially on those who have not.

Framework for understanding movement and physical activity in patients diagnosed with psychosis.

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.

Understanding unusual sensory experiences: a randomised experimental study of a school-based intervention for adolescents.

BACKGROUND: One in ten young people experience unusual sensory experiences (USE), such as hallucinations. From a cognitive perspective, the appraisal of USE determines the impact of these experiences. Negative appraisal, as well as other psychological processes (e.g. thinking flexibility, maladaptive schemas, anxiety/depression), is associated with more distress. Our aim was to (a) develop a universal single-session school-based intervention on USE for adolescents and (b) evaluate the effect of the intervention on appraisals of and help seeking intentions for USE. METHODS: A randomised controlled experimental design with a one-month follow-up was used to test the effectiveness of the intervention in one school. Students (n = 223) aged 12-13 were randomised by class to a single-session intervention on USE or a control intervention (generic mental wellbeing). Participants completed measures of appraisals of and help-seeking intentions for USE at pre- and postintervention and at one-month follow-up. They also completed measures of schemas, thinking flexibility and anxiety/depression at preintervention. RESULTS: Overall, 190 adolescents completed the main outcome measures at all three points. The intervention on USE led to a significant (p < .05) increase of positive appraisals of USE compared with the control, with effects sustained at one-month follow-up. The intervention on USE did not lead to significantly greater help-seeking intentions for USE (p = .26). Adolescents' schemas were associated with appraisals and slow thinking and anxiety/depressive symptoms with help-seeking behaviour for USE. CONCLUSIONS: A single-session universal school-based intervention shows promise by improving appraisals of USE. Further research is required across different school populations.

Automated VR therapy for improving positive self-beliefs and psychological well-being in young patients with psychosis: a proof of concept evaluation of Phoenix VR self-confidence therapy.

BACKGROUND: Low self-confidence in patients with psychosis is common. This can lead to higher symptom severity, withdrawal from activities, and low psychological well-being. There are effective psychological techniques to improve positive self-beliefs but these are seldom provided in psychosis services. With young people with lived experience of psychosis we developed a scalable automated VR therapy to enhance positive-self beliefs. AIMS: The aim was to conduct a proof of concept clinical test of whether the new VR self-confidence therapy (Phoenix) may increase positive self-beliefs and psychological well-being. METHOD: Twelve young patients with non-affective psychosis and with low levels of positive self-beliefs participated. Over 6 weeks, patients were provided with a stand-alone VR headset so that they could use Phoenix at home and were offered weekly psychologist meetings. The outcome measures were the Oxford Positive Self Scale (OxPos), Brief Core Schema Scale, and Warwick-Edinburgh Well-being Scale (WEMWBS). Satisfaction, adverse events and side-effects were assessed. RESULTS: Eleven patients provided outcome data. There were very large end-of-treatment improvements in positive self-beliefs (OxPos mean difference = 32.3; 95% CI: 17.3, 47.3; Cohen's d=3.0) and psychological well-being (WEMWBS mean difference = 11.2; 95% CI: 8.0, 14.3; Cohen's d=1.5). Patients rated the quality of the VR therapy as: excellent (n=9), good (n=2), fair (n=0), poor (n=0). An average of 5.3 (SD=1.4) appointments were attended. CONCLUSIONS: Uptake of the VR intervention was high, satisfaction was high, and side-effects extremely few. There were promising indications of large improvements in positive self-beliefs and psychological well-being. A randomized controlled clinical evaluation is warranted.

Randomised controlled trial of automated VR therapy to improve positive self-beliefs and psychological well-being in young people diagnosed with psychosis: a study protocol for the Phoenix VR self-confidence therapy trial.

INTRODUCTION: The confidence of young people diagnosed with psychosis is often low. Positive self-beliefs may be few and negative self-beliefs many. A sense of defeat and failure is common. Young people often withdraw from many aspects of everyday life. Psychological well-being is lowered. Psychological techniques can improve self-confidence, but a shortage of therapists means that very few patients ever receive such help. Virtual reality (VR) offers a potential route out of this impasse. By including a virtual coach, treatment can be automated. As such, delivery of effective therapy is no longer reliant on the availability of therapists. With young people with lived experience, we have developed a staff-assisted automated VR therapy to improve positive self-beliefs (Phoenix). The treatment is based on established cognitive behavioural therapy and positive psychology techniques. A case series indicates that this approach may lead to large improvements in positive self-beliefs and psychological well-being. We now aim to conduct the first randomised controlled evaluation of Phoenix VR. METHODS AND ANALYSIS: 80 patients with psychosis, aged between 16 and 30 years old and with low levels of positive self-beliefs, will be recruited from National Health Service (NHS) secondary care services. They will be randomised (1:1) to the Phoenix VR self-confidence therapy added to treatment as usual or treatment as usual. Assessments will be conducted at 0, 6 (post-treatment) and 12 weeks by a researcher blind to allocation. The primary outcome is positive self-beliefs at 6 weeks rated with the Oxford Positive Self Scale. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention to treat. ETHICS AND DISSEMINATION: The trial has received ethical approval from the NHS Health Research Authority (22/LO/0273). A key output will be a high-quality VR treatment for patients to improve self-confidence and psychological well-being. TRIAL REGISTRATION NUMBER: ISRCTN10250113.

Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial).

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).

Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses.

BACKGROUND: Persecutory delusions are a major psychiatric problem that often do not respond sufficiently to standard pharmacological or psychological treatments. We developed a new brief automated virtual reality (VR) cognitive treatment that has the potential to be used easily in clinical services. We aimed to compare VR cognitive therapy with an alternative VR therapy (mental relaxation), with an emphasis on understanding potential mechanisms of action. METHODS: THRIVE was a parallel-group, single-blind, randomised controlled trial across four UK National Health Service trusts in England. Participants were included if they were aged 16 years or older, had a persistent (at least 3 months) persecutory delusion held with at least 50% conviction, reported feeling threatened when outside with other people, and had a primary diagnosis from the referring clinical team of a non-affective psychotic disorder. We randomly assigned (1:1) patients to either THRIVE VR cognitive therapy or VR mental relaxation, using a permuted blocks algorithm with randomly varying block size, stratified by severity of delusion. Usual care continued for all participants. Each VR therapy was provided in four sessions over approximately 4 weeks, supported by an assistant psychologist or clinical psychologist. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 2 (therapy mid-point), 4 (primary endpoint, end of treatment), 8, 16, and 24 weeks. The primary outcome was persecutory delusion conviction, assessed by the Psychotic Symptoms Rating Scale (PSYRATS; rated 0-100%). Outcome analyses were done in the intention-to-treat population. We assessed the treatment credibility and expectancy of the interventions and the two mechanisms (defence behaviours and safety beliefs) that the cognitive intervention was designed to target. This trial is prospectively registered with the ISRCTN registry, ISRCTN12497310. FINDINGS: From Sept 21, 2018, to May 13, 2021 (with a pause due to COVID-19 pandemic restrictions from March 16, 2020, to Sept 14, 2020), we recruited 80 participants with persistent persecutory delusions (49 [61%] men, 31 [39%] women, with a mean age of 40 years [SD 13, range 18-73], 64 [80%] White, six [8%] Black, one [1%] Indian, three [4%] Pakistani, and six [8%] other race or ethnicity). We randomly assigned 39 (49%) participants assigned to VR cognitive therapy and 41 (51%) participants to VR mental relaxation. 33 (85%) participants who were assigned to VR cognitive therapy attended all four sessions, and 35 (85%) participants assigned to VR mental relaxation attended all four sessions. We found no significant differences between the two VR interventions in participant ratings of treatment credibility (adjusted mean difference -1·55 [95% CI -3·68 to 0·58]; p=0·15) and outcome expectancy (-0·91 [-3·42 to 1·61]; p=0·47). 77 (96%) participants provided follow-up data at the primary timepoint. Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater improvement in persecutory delusions (adjusted mean difference -2·16 [-12·77 to 8·44]; p=0·69). Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater reduction in use of defence behaviours (adjusted mean difference -0·71 [-4·21 to 2·79]; p=0·69) or a greater increase in belief in safety (-5·89 [-16·83 to 5·05]; p=0·29). There were 17 serious adverse events unrelated to the trial (ten events in seven participants in the VR cognitive therapy group and seven events in five participants in the VR mental relaxation group). INTERPRETATION: The two VR interventions performed similarly, despite the fact that they had been designed to affect different mechanisms. Both interventions had high uptake rates and were associated with large improvements in persecutory delusions but it cannot be determined that the treatments accounted for the change. Immersive technologies hold promise for the treatment of severe mental health problems. However, their use will likely benefit from experimental research on the application of different therapeutic techniques and the effects on a range of potential mechanisms of action. FUNDING: Medical Research Council Developmental Pathway Funding Scheme and National Institute for Health and Care Research Oxford Health Biomedical Research Centre.

A targeted psychological treatment for sleep problems in young people at ultra-high risk of psychosis in England (SleepWell): a parallel group, single-blind, randomised controlled feasibility trial.

BACKGROUND: Sleep disturbance is common and problematic for young people at ultra-high risk of psychosis. Sleep disruption is a contributory causal factor in the occurrence of mental health problems, including psychotic experiences, anxiety, and depression. The implication is that treating sleep problems might have additional benefits on mental health outcomes in individuals at high risk. The present study had two aims: first, to establish the feasibility and acceptability of a randomised controlled trial to treat sleep problems with the aim of reducing psychotic experiences in young people at ultra-high risk of psychosis; and second, to provide proof of concept of the clinical efficacy of the treatment. METHODS: We did a parallel group, single-blind, randomised controlled feasibility trial in two National Health Service trusts in England. Eligible participants were aged 14-25 years, a patient of mental health services, assessed as being at ultra-high risk of psychosis on the Comprehensive Assessment of At-Risk Mental States, and having current sleep problems (score of ≥15 on the self-report Insomnia Severity Index [ISI]). Participants were randomly assigned (1:1) to either a targeted psychological therapy for sleep problems (SleepWell) plus usual care or usual care alone via an automated online system, with non-deterministic minimisation that balanced participants for ISI score and referring service. The SleepWell therapy was delivered on an individual basis in approximately eight 1-h sessions over 12 weeks. Assessments were done at 0, 3, and 9 months, with trial assessors masked to treatment allocation. The key feasibility outcomes were the numbers of patients identified, recruited, and retained, treatment uptake, and data completion. Treatment acceptability was measured with the Abbreviated Acceptability Rating Profile (AARP). In preliminary clinical assessments, the primary clinical outcome was insomnia at 3 and 9 months assessed with the ISI, reported by randomised group (intention-to-treat analysis). Safety was assessed in all randomly assigned participants. The trial was prospectively registered on ISRCTN, 85601537, and is completed. FINDINGS: From Nov 18, 2020, to Jan 26, 2022, 67 young people were screened, of whom 40 (60%) at ultra-high risk of psychosis were recruited. Mean age was 16·9 years (SD 2·5; range 14-23), and most participants identified as female (n=19 [48%]) or male (n=19 [48%]) and as White (n=32 [80%]). 21 participants were randomly assigned to SleepWell therapy plus usual care and 19 to usual care alone. All participants provided data on at least one follow-up visit. 39 (98%) of 40 participants completed the primary outcome assessment at 3 and 9 months. 20 (95%) of 21 participants assigned to SleepWell therapy received the prespecified minimum treatment dose of at least four sessions. The median treatment acceptability score on the AARP was 48 (IQR 46 to 48; n=17; maximum possible score 48). At the post-intervention follow-up (3 months), compared with the usual care alone group, the SleepWell therapy group had a reduction in insomnia severity (ISI adjusted mean difference -8·12 [95% CI -11·60 to -4·63]; Cohen's d=-2·67 [95% CI -3·81 to -1·52]), which was sustained at 9 months (ISI adjusted mean difference -5·83 [-9·31 to -2·35]; Cohen's d=-1·91 [-3·06 to -0·77]). Among the 40 participants, eight adverse events were reported in six participants (two [11%] participants in the usual care group and four [19%] participants in the SleepWell therapy group). One serious adverse event involving hospital admission for a physical health problem was reported in the SleepWell therapy group, and one patient in the usual care alone group transitioned to psychosis. None of these events were classed as being related to trial treatment or procedures. INTERPRETATION: A randomised controlled trial of a targeted psychological sleep therapy for young people at ultra-high risk of psychosis is feasible. Patients can be retained in the trial and assessments done by masked assessors. Uptake of the sleep therapy was high, and we found preliminary evidence of sustained reductions in sleep problems. A definitive multicentre trial is now needed. FUNDING: NIHR Research for Patient Benefit and NIHR Oxford Health Biomedical Research Centre.

The Oxford Agoraphobic Avoidance Scale.

BACKGROUND: Agoraphobic avoidance of everyday situations is a common feature in many mental health disorders. Avoidance can be due to a variety of fears, including concerns about negative social evaluation, panicking, and harm from others. The result is inactivity and isolation. Behavioural avoidance tasks (BATs) provide an objective assessment of avoidance and in situ anxiety but are challenging to administer and lack standardisation. Our aim was to draw on the principles of BATs to develop a self-report measure of agoraphobia symptoms. METHOD: The scale was developed with 194 patients with agoraphobia in the context of psychosis, 427 individuals in the general population with high levels of agoraphobia, and 1094 individuals with low levels of agoraphobia. Factor analysis, item response theory, and receiver operating characteristic analyses were used. Validity was assessed against a BAT, actigraphy data, and an existing agoraphobia measure. Test-retest reliability was assessed with 264 participants. RESULTS: An eight-item questionnaire with avoidance and distress response scales was developed. The avoidance and distress scales each had an excellent model fit and reliably assessed agoraphobic symptoms across the severity spectrum. All items were highly discriminative (avoidance: a = 1.24-5.43; distress: a = 1.60-5.48), indicating that small increases in agoraphobic symptoms led to a high probability of item endorsement. The scale demonstrated good internal reliability, test-retest reliability, and validity. CONCLUSIONS: The Oxford Agoraphobic Avoidance Scale has excellent psychometric properties. Clinical cut-offs and score ranges are provided. This precise assessment tool may help focus attention on the clinically important problem of agoraphobic avoidance.

Development and initial evaluation of a behavioural intervention to support weight management for people with serious mental illness: an uncontrolled feasibility and acceptability study.

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.

The Oxford Positive Self Scale: psychometric development of an assessment of cognitions associated with psychological well-being.

BACKGROUND: Developing, elaborating, and consolidating positive views of the self is a plausible route to increased psychological well-being. We set out to provide an assessment of positive self-beliefs that could be used in research and clinical practice. METHODS: A non-probability online survey was conducted with 2500 UK adults, quota sampled to match the population for age, gender, ethnicity, income, and region. Exploratory factor analysis of a 94-item pool - generated with guidance from people with lived experience of mental health difficulties - was conducted to develop the Oxford Positive Self Scale (OxPos). The item pool was further reduced using regularised structural equation modelling (SEM) before confirmatory factor analysis. Optimal cut-off scores were developed using receiver operating characteristic curves. Additional validations were carried out with two further general population cohorts (n = 1399; n = 1693). RESULTS: A 24-item scale was developed with an excellent model fit [robust χ2 = 995.676; df = 246; CFI = 0.956; TLI = 0.951; RMSEA = 0.049 (0.047, 0.052); SRMR = 0.031]. The scale comprises four factors: mastery; strength; enjoyment; and character. SEM indicated that the scale explains 68.6% of variance in psychological well-being. The OxPos score was negatively correlated with depression (r = -0.49), anxious avoidance (r = -0.34), paranoia (r = -0.23), hallucinations (r = -0.20), and negative self-beliefs (r = -0.50), and positively correlated with psychological well-being (r = 0.79), self-esteem (r = 0.67), and positive social comparison (r = 0.72). Internal reliability and test-retest reliability were excellent. Cut-offs by age and gender were generated. A short-form was developed, explaining 96% of the full-scale variance. CONCLUSIONS: The new open access scale provides a psychometrically robust assessment of positive cognitions that are strongly connected to psychological well-being.

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy.

BACKGROUND: Automated 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. OBJECTIVE: We 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. METHODS: Peer-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. RESULTS: Participants 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. CONCLUSIONS: Automated 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.

Identifying individuals at risk of developing psychosis: A systematic review of the literature in primary care services.

AIM: Psychosis and related disorders are a major public health issue. Early identification and prevention for those at high risk (at-risk-mental-state, ARMS) is important. General practitioners (GPs) are often the first point of contact for health services. In this review we aim to identify (1) the most common methods for identifying individuals with an ARMS in primary care, (2) the methods for improving identification of individuals with an ARMS in primary care, and (3) the most common barriers that prevent GPs from screening for individuals with an ARMS. METHODS: We conducted a systematic review (PROSPERO 42021245095) of quantitative and qualitative studies with no date restriction. Searches were performed in September 2021. Studies' quality was appraised using Mixed Methods Appraisal tool (MMAT). RESULTS: We identified 16 eligible studies, and all but one provided quantitative data. Nearly two-thirds of studies were classified as 'medium' quality. Employing narrative synthesis, we identified three themes relating to (1) improving GP knowledge and confidence in identifying individuals with an ARMS, (2) balancing the over- and under-identification of individuals with an ARMS in primary care, and (3) supporting GPs as significant stakeholders in early diagnosis and treatment of individuals with an ARMS. CONCLUSIONS: Improved identification of individuals with an ARMS is needed. We identified various strategies, including development and implementation of identification methods (e.g., screening measures), educational interventions for GPs (e.g., workshops), and systemic interventions (e.g., simplifying referrals to secondary care, developing integrated services). When implemented successfully, these interventions may help facilitate the access to appropriate care for individuals with an ARMS.