BACKGROUND:Initial patient perceptions of a treatment's credibility, and expectations for improvement, have been shown to predict to a small degree outcomes for common mental health disorders. This study aimed to discover: how patients with psychosis initially perceive psychological therapy's credibility and likely success; whether there are predictors of these first views; and, primarily, if such ideas predict improvement in persecutory delusions. METHODS:We analysed first therapy session data on credibility and expectancy from 195 patients with non-affective psychosis taking part in clinical trials treating persecutory delusions. Baseline assessments before randomisation to therapy were used to identify potential predictors of credibility and expectancy. First session credibility and expectancy scores were tested as predictors of persecutory delusion severity six months later. RESULTS:Most patients were optimistic about therapy's potential. Baseline delusion severity did not predict credibility, β = -0.02, p = .742, or expectancy, β = -0.03, p = .632. Higher psychological well-being predicted higher levels of expectancy, β = 0.23, p = .001. Higher levels of credibility, β = -0.17, p = .021, and expectancy, β = -0.17, p = .020, predicted lower severity of persecutory delusions six months later. Credibility, β = 0.00, p = .970, and expectancy, β = -0.21, p = .074, did not significantly predict uptake of therapy sessions. CONCLUSIONS:Treatment credibility and expectancy may account for a small proportion of improvement when psychological interventions are used to treat severe paranoia. The results are comparable to those for common mental health disorders. There was little prediction of patient variability in credibility and expectancy. It will be helpful to understand a patient's initial views on intervention so that any concerns can be addressed.

At the heart of a persecutory delusion is an incorrect perception of threat from others. This makes the person feel very unsafe. Overcoming such delusions therefore means establishing a sense of safety, and thus a realisation that there is no current threat. Discovering that one is safe functions as the counterweight to feeling unsafe. The counterweight shifts expectations and changes beliefs. In this article, we describe how safety may be learned. This includes how to engage patients, framing the finding of safety, switching from threat to safety mode, using experiential learning, and consideration of blocking beliefs that may prevent new learning. Key points are to: frame intervention as an opportunity to find greater safety in the world so that meaningful activities can be resumed; repeatedly measure the learning of safety; make new benign associations with the internal and external cues driving the delusions; keep the new learning to the present and future, suitably circumscribed for an individual, so that potential for discord is limited; carry out safety-establishing behavioral experiments that allow for the dropping of defense behaviors, the reframing of evidence for the delusion, and diminish the pervasiveness of the perceived threat; and help patients move from situation-specific instances of safety to more generalised belief change. Enabling patients to re-discover safety in their everyday lives-decisively tipping the scales in favor of the counterweight-is the most transformational element of successful psychological intervention for persecutory delusions.

Background:Fear of needles is distressing in itself but can also lead to avoidance of vaccinations, blood donation, and medical tests and treatments. Working with adolescents with needle fears, we developed an automated virtual reality (VR) therapy. We set out to evaluate its efficacy. Methods:We conducted an initial proof-of-concept cohort study followed by a Phase II randomised controlled trial. Participants were included if they were 12-15 years old and had significant needle fears that they would like treated. The proof-of-concept testing was a pre- to post-cohort study. To proceed to an RCT an effect size of at least 0.6 on the Injection Phobia Scale - Anxiety (child version) (IPS) was required. The Phase II test was a parallel group, single-blind, randomised controlled trial in one centre in England. Participants were randomly assigned (1:1) to either the VR therapy or no treatment, using a permuted blocks algorithm with randomly varying block size. The VR therapy was provided in approximately three sessions over two to three weeks. The trial assessor was masked to group allocation. Outcomes were assessed at 0, 3 (end of treatment) (primary endpoint), and 6 weeks. The primary outcome was needle fear, assessed by the IPS. Outcome analyses were done in the intention-to-treat population. Moderation and mediation tests were also planned. The RCT was prospectively registered with the ISRCTN registry, ISRCTN74002253. Findings:From March 26th, 2024, to June 7th, 2024, 12 participants (5 [42%] males; 6 [50%] females, 1 [8%] prefer not to say, mean age 13.4 years [SD = 0.8, range 12-15]; 10 [83%] White, 1 [8%] other, 1 [8%] prefer not to say) were recruited for the cohort study. After the VR therapy, needle fears as assessed by the IPS reduced on average by 15.2 points [95% C.I. 9.2, 21.1, n = 11, Cohen's d = 1.5]. There were no serious adverse events. The RCT could therefore proceed. From October 28th, 2024, to July 15th, 2025, 60 participants (26 [43%] males; 32 [53%] females, 2 other [3%], mean age 13.4 years [SD = 0.9, range 12-15]; 57 [95%] White, 3 [5%] other) were recruited for the RCT. Compared with no treatment, there was strong evidence that VR therapy led to a reduction in needle fears (adjusted mean difference = -14.07, 95% C.I. -17.40, -10.73, p < 0.001, n = 60, Cohen's d = 1.34). The benefits were maintained at follow-up (adjusted mean difference = -14.67, 95% C.I. -18.00, -11.33, p < 0.001, n = 60, Cohen's d = 1.39). There were no serious adverse events. Interpretation:An automated VR therapy, which is potentially scalable, had efficacy in reducing self-reported needle fears in adolescents. Given that this is an age at which people often have a formative experience of medical procedures, it is an important time to reduce needle fears. The intervention requires testing in a Phase III clinical trial. A key focus would be assessing whether the VR therapy increases vaccine uptake in young people who have initially refused due to needle fears. Funding:Beryl Alexander Charity and the NIHR Oxford Health Biomedical Research Centre and NIHR Oxford Biomedical Research Centre.

Introduction:Worry is common and distressing in psychotic disorders, contributing to the onset and persistence of persecutory delusions. A previously developed 8-week manualized cognitive behavioral therapy (CBT)-worry intervention has shown efficacy in treating persecutory delusions, compared with standard care. We aimed to test CBT-worry's impact on persecutory delusions at 8 weeks, as previously reported, delusions at 24 weeks, and secondary clinical outcomes, relative to an active comparison therapy. Materials and Methods:A two-arm, assessor-blinded, randomized controlled trial was conducted. Sixty-two adults with a non-affective psychotic disorder and current persecutory delusion were randomized to CBT-worry (n = 32) or befriending (n = 30). The preregistered primary clinical outcome was persecutory delusion severity. Outcomes were assessed at baseline, post-treatment (8 weeks), and at follow-up (24 weeks). Results:Regarding primary outcomes, CBT-worry was not superior to befriending in treating persecutory delusions at post-treatment or follow-up (P's > .05). For secondary exploratory outcomes, CBT-worry demonstrated superiority over befriending for self-reported worry (d = .26, P = .006), depression (d = .23, P = .018), perseveration (d = .21, P = .024), insomnia (d = .25, P = .01), and asocial beliefs (d = .23, P = .022) and assessor-rated affective symptoms (d = .36, P < .001) post-treatment. At follow-up, no significant between-group treatment effects were found after correction for multiple comparisons. Discussion:A brief CBT-worry intervention did not outperform befriending in the treatment of persecutory delusions. CBT-worry did, however, demonstrate significant benefit for affective symptoms post-treatment, compared to befriending. At follow-up, gains were maintained in CBT-worry but were also observed in befriending, minimizing group differences. Limitations include a small sample size, lack of a non-clinical control, and 20% drop-out. ClinicalTrials.gov (NCT04748679).

BACKGROUND AND HYPOTHESIS:Individuals with psychosis often experience levels of anxious avoidance comparable to patients with agoraphobia, causing detrimental effects on quality of life and functional outcomes. Automated virtual reality delivered cognitive behavioural therapy (CBT) may represent a promising treatment approach for addressing agoraphobic avoidance in patients with psychosis. We sought to evaluate the feasibility of using the virtual reality application gameChange as a treatment option for agoraphobic avoidance in people with psychosis in psychosis treatment units in Oslo, Norway. STUDY DESIGN:This study was conducted as a two arm non-randomized site-based feasibility trial (gameChange plus CBTp and standard care or gameChange plus standard care) across 3 treatment units for patients diagnosed with psychosis. Participants were allocated to intervention arm based on the type of CBTp available at their respective treatment units. It was aimed to recruit thirty patients with psychosis. Outcomes were assessed at baseline and post-treatment (13 weeks). Outcomes were recruitment-, retention-, and adherence-rates as well as patient satisfaction and a range of self-reported symptom measures. STUDY RESULTS:A total of 32 patients were referred: 28 patients were eligible, and 27 participated. 22 patients (81%) received an adherent dose of gameChange. 21 patients (77.7%) completed the post-treatment assessment. Participants reported high satisfaction with the intervention. gameChange was associated with improvements in symptomatology, most notably in the domains of functioning and depression. CONCLUSIONS:Findings suggest that incorporating virtual reality delivered cognitive behavioural therapy interventions in a Norwegian health care setting is feasible. Randomised controlled trials are warranted to assess treatment efficacy.

Study Objectives:Tiredness is a common presentation composed of sleepiness (propensity towards sleeping) and fatigue (feelings of physiological exhaustion). Differentiating between these presentations is important for diagnosis and management. The current study reports on the development and validation of an integrated measure of tiredness (Tiredness Identification Index-TIDI) incorporating assessment of sleepiness and fatigue, and the relationship of the measure with sleep and mental health outcomes. Methods:A sample of 6706 adult participants responded to a pool of sleepiness and fatigue items. Regularized structural equation modelling and confirmatory factor analysis were used to refine the items and factor structure based on convergence against validation measures of fatigue and sleepiness. Regression analyses were then applied to test relationships of the sleepiness and fatigue factors with sleep, mental health, and wellbeing variables. Results:An 8-item scale was developed, composed of a sleepiness (TIDI-sleepiness) and fatigue (TIDI-fatigue) factor with divergent and convergent validity, alongside a general tiredness factor. Higher TIDI-sleepiness was associated with increased apnoea risk and shorter sleep duration, whereas TIDI-fatigue was associated with increased insomnia and reduced sleep efficiency. Controlling for TIDI-sleepiness, TIDI-fatigue was associated with increased depression, anxiety, reduced well-being, and lower physical activity. Increased TIDI-sleepiness and TIDI-fatigue were both associated with paranoia and hallucinations. Conclusions:The results indicate that the TIDI can be used as a brief scale to measure and differentiate fatigue and sleepiness, particularly in non-clinical populations and for research purposes. Assessment of its validity in discriminating fatigue and sleepiness in relevant clinical sleep, mental, and physical health populations should be a focus of future research.

Virtual reality (VR) simulations may provide a safer way for people with high levels of anger to practise overcoming unhelpful reactions. The first step in such treatment development is to test whether anger can be caused by a simulation of a common triggering situation. The aim was to test whether an intimidating VR social environment raises anger in men and whether the effect is more pronounced in those with problematic anger. A mixed-design experimental study was conducted. Two hundred and sixty-five people were screened: 20 men were allocated to a high anger group based on the clinical cut-off of the Dimensions of Anger Reactions-5 (DAR-5) (> 12) and 22 men to a low anger group (DAR-5 score < 8). Anger was assessed pre- and post-exposure to an intimidating VR lift scenario featuring seven characters. Appraisals of the virtual characters were also assessed. Regression analyses were used to test the effects of anger group and appraisals on anger response whilst controlling for baseline anger. Across all participants, anger significantly increased from pre- to post-VR (t(41) = 3.63, p < .001, d = 0.56). There was a significant effect of group on the extent anger was triggered by the VR scenario (β = 0.277, t(df) = 2.443, p = .019, SE = 2.098) with the high anger group showing a greater anger response. Hostile appraisal of virtual characters (β = 0.416, t(df) = 3.285, p = .002, SE = 0.038) was associated with a greater anger response. The reactions to the virtual reality simulation mirrored what may be expected in the real world. A mildly stressful VR social situation raised anger in all but this was more pronounced in men who have difficulties with anger. VR has the potential to be used in the assessment and treatment of anger.

A theory-driven cognitive therapy (Feeling Safe) has produced much better outcomes for patients with persecutory delusions. There are four distinct response classes: very high delusion conviction with large improvement, very high delusion conviction with no response, high delusion conviction with large improvement, and high delusion conviction with modest improvement. Our objective was to apply principal trajectories analysis, a novel statistical method, to original trial data to estimate whether these groups may have responded differently to a different intervention: befriending. One hundred and thirty patients with persistent persecutory delusions were randomised to six months of Feeling Safe or befriending. Baseline assessments were used to assign patients allocated to befriending (who did not receive Feeling Safe) into the four Feeling Safe response classes. The treatment effect, including on potential mediators, was then estimated for these classes. Patients in two treatment response classes (Very high conviction/large improvement, High conviction/large improvement) benefited more from Feeling Safe, patients in one group (Very high conviction/no improvement) benefited more from befriending, and patients in the remaining group (High conviction/moderate improvement) benefited equally from the interventions. Mechanism differences were detected when Feeling Safe was superior to befriending, but not when befriending was superior. There may be patients with psychosis who benefit more from one type of therapy than another, likely due to different change mechanisms. The application of principal trajectories has generated testable hypotheses and a potential step toward personalised treatment. We recommend an investigation of whether sequential provision of the treatment types could enhance patient outcomes. Keywords: persecutory, delusions, outcome trajectories, psychosis, cognitive therapy.

Background:Although the application of self-monitoring (ambulatory assessment) and visual feedback in psychological interventions has yielded promising results, there are currently no reports on using self-monitoring and feedback during a complete therapy. The online m-Path platform provides a tailorable framework for integrating self-monitoring and visual feedback within different psychological interventions. Methods:Therapy-specific questionnaires and visual feedback were developed within the online m-Path platform as part of the Feeling Safe-NL trial (registration number: ISRCTN25766661) for regular CBT for psychosis (CBTp) and the Feeling Safe Programme combined with peer counselling (the Feeling Safe-NL Programme). The design process involved people with lived experience, psychologists, peer counsellors, researchers, and software developers. The design principles included that the system should be 1) easy to use, 2) suitable for use during a six-month therapy, 3) focussed on positive and goal-aligned outcomes, 4) understandable by patients and professionals, and 5) informing, guiding, and promoting therapy. Design principles were evaluated using compliance data and a patient questionnaire. Results:The system was used by 21 patients, of which nine completed the questionnaires for the full therapy period, 168 days on average. Usability data from patients revealed that the system was easy to use, well-explained, and suitable for use over six months of therapy. The patients also reported that the questions overall positively affected their emotions and that the feedback was insightful. Conclusion:The results support the successful application of the design principles to promote the integration of the self-monitoring and visual feedback system within specific CBTp interventions.

Background To drive improvement in clinical services, an important innovation will be to regularly assess patients' psychotic experiences in order to guide, monitor and, when needed, alter treatment provision. The great heterogeneity in presentations of psychosis means that a comprehensive assessment battery is impractical. A plausible solution is computerised adaptive testing (CAT), which uses real-time computation to present the most informative questions to an individual. Fewer questions are needed to reach similar precision as a full questionnaire.Objective We tested the potential of a CAT for paranoia to halve the number of items that need to be presented.Methods We used the established item response theory psychometric properties of the 10-item Revised Green et al Paranoid Thoughts Scale (Persecution) to run CAT simulations in four datasets in which participants had completed the full scale: a representative survey of 10 382 UK adults; a clinical trial with 319 patients with psychosis; a cohort study of 836 National Health Service (NHS) male patients with psychosis; and a clinical trial with 89 patients with persecutory delusions. The CAT algorithm used the graded response model and the test was concluded when the SE of estimation dropped below 0.3 or five items had been answered.Findings On average, the CAT administered 4.2, 4.0, 4.2 and 4.0 items to each person in the four datasets. The correlations between the CAT score and the full-scale paranoia score were 0.95, 0.94, 0.94 and 0.87. Minimal systematic error in paranoia estimation occurred (mean bias scores=-0.01, -0.06, -0.07 to -0.10). Estimation was the least precise for people at the boundary of normal and elevated levels of paranoia.Conclusions In datasets with people across the whole paranoia continuum, accurate estimates of paranoia can be provided by a CAT with fewer than half the items of the full scale. Tailored testing may work well with people with psychosis.Clinical implications CAT may be a way to implement informative measurement-based care in psychosis services.

Introduction: Agoraphobic avoidance, fear of situations that seem hard to escape, is common across mental disorders and often remains untreated due to stigma and limited service access. Automated virtual reality (VR) exposure therapy offers a scalable alternative by enabling safe, guided simulations of feared situations. This randomized controlled trial evaluated the efficacy of a culturally adapted version of gameChange VR for reducing agoraphobic avoidance among adults in Hong Kong without psychiatric diagnoses. Methods: 272 participants were randomly assigned to either a three-session VR intervention (n = 146) or a waitlist control condition (n = 126). Assessments were conducted at baseline, 3-week, and 1-month follow-ups. Compared to the control condition, participants in the VR intervention condition showed significant reductions in the primary outcome of agoraphobic avoidance (Cohen’s d = 0.89), and all the secondary outcomes of agoraphobic distress (d = 1.0), social anxiety (d = 0.91), fear of negative evaluation (d = 0.68), generalized anxiety (d = 0.50), depressive symptoms (d = 0.67), and functional impairment (d = 0.85) at 3 weeks. Results: Significant group differences for all outcomes remained at the 1-month follow-up. Higher baseline levels of agoraphobic symptoms were associated with larger improvements in agoraphobic avoidance. Conclusion: These findings suggest that the automated VR intervention is effective in reducing agoraphobic symptoms in non-clinical populations and appears to be a scalable treatment in Asia where stigma is strong. Future studies could include longer follow-ups and address pandemic-related confounds on avoidance behaviours.

It is common in mental health care to ask about people's days but comparatively rare to ask about their nights. Most patients diagnosed with schizophrenia struggle at nighttime. The next-day effects can include a worsening of psychotic experiences, affective disturbances, and inactivity, which in turn affect the next night's sleep. Objective and subjective cognitive abilities may be affected too. Patients commonly experience a mix of sleep difficulties in a night and across a week. These difficulties include trouble falling asleep, staying asleep, or sleeping at all; nightmares and other awakenings; poor-quality sleep; oversleeping; tiredness; sleeping at the wrong times; and problems establishing a regular sleep pattern. The patient group is also more vulnerable to obstructive sleep apnea and restless legs syndrome. We describe in this article how the complex presentation of non-respiratory sleep difficulties arises from variation across five factors: timing, mental state, need for sleep, self-care, and environment. We set out 10 illustrative patterns of such difficulties experienced by patients with non-affective psychosis. These sleep problems are eminently treatable with intensive psychological therapy delivered over approximately eight sessions. We describe key techniques and their typical order of implementation by presentation. Sleep problems are an important issue for patients. Giving them the therapeutic attention patients often desire brings both real clinical benefits and improves views of services. Treatment is also very likely to lessen psychotic experiences and mood disturbances while improving daytime functioning and quality of life. Tackling sleep difficulties can be a route toward the successful treatment of psychosis.

Introduction Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things—for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange.Methods and analysis 200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment.Ethics and dissemination The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS.Trial registration number ISRCTN79060696.

Background:Virtual reality (VR) is showing increasing promise for assessing, understanding, and treating mental health difficulties. Virtual humans (VHs) represent a key aspect within many VR mental health applications. While VHs can play diverse roles and display varied characteristics, their design and influence have rarely been the primary focus of mental health research. Objective:We aimed to carry out a systematic review of how VHs in immersive VR have been used in applications for mental health, focusing on their roles and interaction types, and the human characteristics being tested. Methods:Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched PubMed, MEDLINE, PsycINFO, Scopus, and Web of Science, using defined keyword combinations involving VR, VHs, and mental health. Eligible studies included peer-reviewed research using immersive VR with VHs in a mental health context, without restrictions on study design or population. We excluded nonimmersive VR, nonmental health applications, and papers without empirical data. Data were synthesized narratively, and a taxonomy to categorize VHs that we developed was used. Results:A total of 79 studies met all eligibility criteria. VHs were most frequently applied in studies on social anxiety (n=18), eating disorders (n=18), and psychosis (n=15). They were primarily used as active social interaction partners (n=40), as part of virtual crowds (n=16), and as virtual bodies for participants (n=23). Explicit interactions dominated active partner studies, while implicit and passive or no interactions were prevalent in crowd and body studies. Over half of the studies (n=44) varied the VH characteristics, with body size and gender being the most common variables, and personality was explored in fewer studies (n=5). Only a limited number of studies provided detailed descriptions of VH appearance and behavior, with some including still images and videos. Conclusions:VHs are versatile tools to be used within VR mental health applications, but their design features are inconsistently reported and insufficiently examined in relation to intervention outcomes. Evidence is limited by heterogeneity in study aims, designs, and populations, and by incomplete reporting of VH characteristics, which constrains replication and cross-study comparison. Standardized reporting and systematic investigations of VH design are needed to optimize their roles in evidence-based mental health applications.

Introduction Persecutory delusions are very common in severe mental health disorders such as schizophrenia. Existing treatments often do not work well enough. We developed a face-to-face theory-driven psychological intervention, called Feeling Safe, that produces very large reductions in persistent persecutory delusions. The challenge now is to make Feeling Safe widely available. So, we developed a 6-month supported online version, called Feeling Safer. The aim is an intervention that patients can easily access and use, reduces persecutory delusions and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. Initial proof of concept testing of Feeling Safer was very encouraging. In a randomised controlled trial, we now plan to test whether Feeling Safer is efficacious for patients and can be successfully delivered by any of three different mental health staff groups (peer-support workers, graduate psychologists and cognitive behavioural therapy (CBT) therapists). We will also test whether Feeling Safer works equally across gender, age, ethnicity and cognitive functioning (moderation) and whether Feeling Safer works via the targeted psychological processes (mediation).Methods and analysis The study design is a multicentre, single-blind (outcome assessor), parallel, four-arm randomised controlled trial; 484 patients with persistent persecutory delusions will be randomised to one of the four conditions (1:1:1:1): Feeling Safer (added to treatment as usual (TAU)) supported by peer-support workers, or Feeling Safer (added to TAU) supported by graduate mental health workers including assistant psychologists, or Feeling Safer (added to TAU) supported by CBT therapists or TAU. Feeling Safer will be provided for 6 months with a staff member. Assessments will be conducted at 0, 3, 6 and 9 months by research assistants blind to group allocation. The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale—Delusions. The secondary outcomes are other psychiatric symptoms (depression, anxiety, insomnia, agoraphobia and paranoia), psychological well-being, recovery, activity and health-related quality of life. Analysis will be conducted under a treatment policy strategy following the intention-to-treat principle, incorporating data from all participants including those who do not complete treatment. Moderation and mediation will be tested. A within-trial cost-effectiveness analysis will be conducted of Feeling Safer compared with TAU.Ethics and dissemination The trial has received ethical approval from the NHS Health Research Authority (23/LO/0951). Informed consent will be obtained from all participants. A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.Trial registration number ISRCTN93974770.

Treatments for patients diagnosed with psychosis need to be improved. Clinical trials are an important way of assessing the efficacy of new treatments. However, recruiting patients into trials is challenging. This study sought to better understand the reasons for this from the perspective of research assistants. A qualitative study underpinned by a critical realist ontology and contextualist epistemology. Research assistants who had recruited patients with psychosis into trials, primarily of psychological interventions, were interviewed. Reflexive thematic analysis was used to identify themes. Overarching themes representing four types of factors influencing recruitment of patients with psychosis into clinical trials were generated: patient, clinical team, research team, and NHS infrastructure. Patients largely wished to take part in trials but needed time to build trust with research assistants. Clinical teams held the power in suggesting patients for trials; therefore, it was essential for research teams to build strong relationships with clinical staff. Research teams recruiting into trials benefited from lived experience expertise, support systems, and institutional knowledge. A key NHS infrastructure factor was that mental health staff had limited time to consider trials for their patients. Trial participation needs to be made more accessible to patients with psychosis, who often want to take part but lack opportunities. Methods of increasing accessibility could include identifying and addressing barriers to referral from clinical teams, employing multiple recruitment strategies, and flexible appointment formats. Qualitative research with clinical teams and patients will also help in developing the understanding of barriers to recruitment.

People with psychosis typically show high levels of sedentary behaviour and low levels of physical activity. Effective interventions are needed, and staff will play a crucial role in implementation. Aims: To understand staff perspectives on reducing sedentary behaviour and increasing physical activity. Eighteen staff from NHS mental health trust community teams were interviewed, with data analysed using reflexive thematic analysis. Four themes were developed: (1) Choosing to target movement: staff recognise the need to address movement but struggle to prioritise it; (2) Encouraging but not steamrolling: balancing encouragement without pushing too hard is essential for motivation; (3) Tapping the reservoir of staff knowledge: staff possess valuable expertise to leverage; (4) Using lived experience: lived experience accounts effectively motivate and inspire hope. Despite recognising the importance of the issue, limited resources in services hinders prioritisation of increasing patient movement, and interventions are often not attempted. Adapting routine practices and recruiting support (e.g. from willing carers) may increase intervention success without burdening staff.

Background Based on an efficacious face-to-face theory-driven psychological therapy for persecutory delusions in the context of psychosis, we set out to develop a scalable guided 6-month online program. The aim was an intervention that patients can easily access and use, produces large clinical effects, and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. We report here the proof-of-concept testing. At least moderate-sized clinical effects were required to progress to a randomized controlled trial (RCT). Methods In the 6-month Feeling Safer online program, a certified medical device, patients complete a brief assessment and then are provided with up to 10 modules that match their difficulties. Regular remote meetings with a mental health professional also take place. These may be supplemented by in-person visits. A pre- to post-treatment cohort trial was conducted with 14 patients with persistent persecutory delusions. The primary outcome was the Psychotic Symptoms Rating Scale (PSYRATS)-Delusions. Results Satisfaction and usability ratings of the program were high. Very large reductions in persecutory delusions were observed (PSYRATS mean reduction = 7.1, 95% C.I. = 3.4, 10.8, n = 13, Cohen’s d = 3.0). There were large improvements in paranoia, anxiety, depression, agoraphobic distress, psychological wellbeing, meaningful activity, personal recovery, recovering quality of life, and moderate improvements in insomnia, agoraphobic avoidance, and quality of life. Conclusions The clinical effects associated with Feeling Safer were very high, comparable to those seen in the evaluations of the face-to-face therapy, and enable progression to an RCT.