What should inpatient psychological therapies be for? Qualitative views of service users on outcomes.

BACKGROUND: There is limited research on what, when and how outcomes should be measured in psychological therapy trials in acute mental health inpatient wards. OBJECTIVES: This study aimed to consider what outcomes service users think are important to measure. METHODS: This qualitative study explored the views of 14 participants, who had an inpatient admission within the last year, on outcomes of psychological therapies using semistructured interviews. Data were analysed using thematic analysis from a critical realist perspective with both inductive and deductive coding. RESULTS: The 126 outcomes that were important to participants were mapped onto an established taxonomy of outcomes across different health areas and the socioecological framework to consider the wider context and help summarise the outcomes. Most of the outcomes were mapped to the intrapersonal and interpersonal level. In addition to the outcome mapping, three themes were constructed from the qualitative data: (1) I am not a problem I am a person, (2) Feeling cared for and loved, (3) What does getting better look like. CONCLUSIONS: Our results highlight the need for patient-reported outcomes which are cocreated with service users, disseminating research and training on preventing dehumanising experiences, enhancing psychological safety and therapeutic relationships and improving access to psychological therapy. PATIENT OR PUBLIC CONTRIBUTION: The wider People with Personal Experience Involvement Committee at the University of Bath were consulted which included a focus group during the early planning stages. We also collaborated with a person with personal experience, at every stage of the research. This included developing our research question and aims, protocol, participant documents (e.g., information and debrief forms), advertisement and recruitment strategy, interview topic guide, the codes, the final themes and quotes and reviewing the manuscript. People with lived experience of being admitted to an acute mental health inpatient ward participated in our study.

Acceptability of integrating smoking cessation treatment into routine care for people with mental illness: A qualitative study.

INTRODUCTION: Improving Access to Psychological Therapies (IAPTs) Services could offer smoking cessation treatment to improve physical and psychological outcomes for service users, but it currently does not. This study aimed to understand participants' views and experiences of receiving a novel smoking cessation intervention as part of the ESCAPE trial (intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety). We used the Capability, Opportunity and Motivation Model of Behaviour (COM-B) to understand the (i) acceptability of the integrated smoking cessation treatment, (ii) views of psychological well-being practitioners' (PWPs) ability to deliver the smoking cessation treatment and (iii) positive and negative impacts of smoking cessation treatment. METHODS: This was a qualitative study embedded within a feasibility randomized-controlled trial (ESCAPE) in primary care services in the United Kingdom (IAPT). Thirty-six participants (53% female) from both usual care and intervention arms of the ESCAPE trial, including both quitters and nonquitters, were interviewed using semi-structured interviews. Data were analysed using a framework approach to thematic analysis, using the COM-B as a theoretical frame. RESULTS: Psychological Capability: Integrated smoking cessation treatment was acceptable and encouraged participants to reflect on their mental health. Some participants found it difficult to understand nicotine withdrawal symptoms. MOTIVATION: Participants were open to change during the event of presenting to IAPT. Some described being motivated to take part in the intervention by curiosity, to see whether quitting smoking would help their mental health. Physical Opportunity: IAPT has a natural infrastructure for supporting integrated treatment, but there were some barriers such as session duration and interventions feeling segmented. Social Opportunity: Participants viewed PWPs as having good interpersonal skills to deliver a smoking cessation intervention. CONCLUSION: People with common mental illness generally accepted integrated smoking cessation and mental health treatment. Smoking cessation treatment fits well within IAPT's structure; however, there are barriers to implementation. PATIENT OR PUBLIC CONTRIBUTION: Before data collection, we consulted with people with lived experience of smoking and/or mental illness and lay public members regarding the aims, design and interview schedules. After analysis, two people with lived experience of smoking and mental illness individually gave feedback on the final themes and quotes.

Surviving and thriving - a mixed-methods study of staff experiences of occupational wellbeing in a psychiatric place of safety service.

BACKGROUND: Under the S136 of the UK Mental Health Act, people experiencing a mental health crisis may be taken to a locally agreed location (Place of Safety) by police for urgent assessment. Research has shown that mental health professionals (MHPs) face high levels of burnout, but we know very little about the particular challenges staff who work in extreme clinical settings such as a Place of Safety service face. AIM: This study aimed to fill this gap by exploring the wellbeing experiences of staff in a Place of Safety service. METHOD: A mixed-methods approach was used, with quantitative data on job satisfaction (Job Satisfaction Survey) and burnout (Maslach Burnout Inventory-Human Services Survey) and qualitative data from focus groups. Purposive sampling was used. Qualitative data was analysed using thematic analysis and descriptive statistics were calculated for the quantitative data. RESULTS: Twenty staff scored within the moderate range for emotional exhaustion, depersonalisation and personal accomplishment, and in the satisfied range for job satisfaction. Three overarching themes were identified: (i) united as insiders, (ii) surviving and thriving, and (iii) narratives of coping. CONCLUSIONS: Despite unique setting-related stressors, participants showed comparable levels of wellbeing to other MHPs. Implications are discussed.

Epistemic injustice amongst clinical and non-clinical voice-hearers: A qualitative thematic analysis study.

OBJECTIVES: Research has suggested people who hear voices may be at risk of epistemic injustice. This is a form of discrimination whereby someone is unfairly judged to be an unreliable knower (testimonial injustice) or is unable to contribute to, and therefore access, concepts that make sense of their experience within mainstream society (hermeneutical injustice). Voice-hearing occurs both in people who are mental health service users and in the general population (clinical and non-clinical voice-hearers, respectively). The degree of distress and impairment associated with voices has been shown to relate to how individuals make sense of their experiences and how others respond to their identity as a voice-hearer. The aim of this study was to explore people's experiences of epistemic injustice in relation to voice-hearing and to understand how these may differ between clinical and non-clinical voice-hearers. DESIGN: A qualitative design was used. METHOD: Eight clinical and nine non-clinical voice-hearers partook in semi-structured interviews, which were analysed using thematic analysis. RESULTS: Three pairs of themes related to (i) identity, (ii) relationships and (iii) power and position were constructed across the clinical and non-clinical groups, and two shared themes within both groups were created relating to testimonial and hermeneutical injustice. CONCLUSION: Both clinical and non-clinical voice-hearers described experiencing epistemic injustice in wider society. The presence of a 'safe haven' (e.g. spiritualist churches) for non-clinical voice-hearers ameliorated the impact of this to some degree, by allowing people to make connections with others with similar experiences within a non-judgemental and accepting community.

Is mindfulness for psychosis harmful? Deconstructing a myth.

Mindfulness-based therapies are increasingly available for a range of mental disorders, such as depression and anxiety. However, there remain concerns that mindfulness has the potential to exacerbate psychosis, despite a growing body of literature demonstrating effectiveness. These concerns may relate to long-standing perceptions about the suitability of offering psychological therapies to people with psychosis.

Mindfulness-based crisis interventions (MBCI) for psychosis within acute inpatient psychiatric settings; a feasibility randomised controlled trial.

BACKGROUND: Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. Brief inpatient talking therapies for psychosis could help reduce re-admission rates. The primary aim was to assess feasibility and acceptability of a novel, brief, mindfulness-based intervention for inpatients with psychosis. The secondary aim was to collect pilot outcome data on readmission rate, at 6 and 12 months (m) post discharge, and self-report symptom measures at 6 m. METHODS: The amBITION study (BrIef Talking therapIes ON wards) was a parallel group, feasibility randomised controlled trial (RCT). In addition to treatment as usual (TAU), eligible inpatients with psychotic symptoms were randomly allocated to receive either (Mindfulness-Based Crisis Intervention; MBCI) or a control intervention (Social Activity Therapy; SAT), for 1-5 sessions. RESULTS: Fifty participants were recruited (26 MBCI; 24 SAT); all received at least 1 therapy session (mean = 3). Follow-up rates were 98% at 6 m and 96% at 12 m for service use data extracted from clinical notes, and 86% for self-report measures. At 6 m follow-up, re-admission rates were similar across groups (MBCI = 6, SAT = 5; odds ratio = 1.20, 95% CI: 0.312-4.61). At 12 m follow-up, re-admissions were lower in the MBCI group (MBCI = 7, SAT = 11; odds ratio = 0.46, 95% CI: 0.14-1.51). Three participants experienced adverse events; none was related to trial participation. CONCLUSIONS: Delivering a brief mindfulness-based inpatient intervention for psychosis is feasible and acceptable, and may reduce risk of short-term readmission. These promising findings warrant progression to a larger clinical effectiveness trial. TRIAL REGISTRATION: ISRCTN37625384.

Overgeneral autobiographical memory bias in clinical and non-clinical voice hearers.

BACKGROUND: Hearing voices can be a distressing and disabling experience for some, whilst it is a valued experience for others, so-called 'healthy voice-hearers'. Cognitive models of psychosis highlight the role of memory, appraisal and cognitive biases in determining emotional and behavioural responses to voices. A memory bias potentially associated with distressing voices is the overgeneral memory bias (OGM), namely the tendency to recall a summary of events rather than specific occasions. It may limit access to autobiographical information that could be helpful in re-appraising distressing experiences, including voices. METHODS: We investigated the possible links between OGM and distressing voices in psychosis by comparing three groups: (1) clinical voice-hearers (N = 39), (2) non-clinical voice-hearers (N = 35) and (3) controls without voices (N = 77) on a standard version of the autobiographical memory test (AMT). Clinical and non-clinical voice-hearers also completed a newly adapted version of the task, designed to assess voices-related memories (vAMT). RESULTS: As hypothesised, the clinical group displayed an OGM bias by retrieving fewer specific autobiographical memories on the AMT compared with both the non-clinical and control groups, who did not differ from each other. The clinical group also showed an OGM bias in recall of voice-related memories on the vAMT, compared with the non-clinical group. CONCLUSIONS: Clinical voice-hearers display an OGM bias when compared with non-clinical voice-hearers on both general and voices-specific recall tasks. These findings have implications for the refinement and targeting of psychological interventions for psychosis.

Mindfulness for Psychosis Groups; Within-Session Effects on Stress and Symptom-Related Distress in Routine Community Care.

BACKGROUND: There is an emerging evidence base that mindfulness for psychosis is a safe and effective intervention. However, empirical data on the within-session effects of mindfulness meditation was hitherto lacking. AIMS: The aim of the study was to assess the impact of taking part in a mindfulness for psychosis group, using a within-session self-report measure of general stress, and symptom-related distress. METHOD: Users of a secondary mental health service (n = 34), who experienced enduring psychotic symptoms, took part in an 8-week mindfulness for psychosis group in a community setting. Mindfulness meditations were limited to 10 minutes and included explicit reference to psychotic experience arising during the practice. Participants self-rated general stress, and symptom-related distress, before and after each group session using a visual analogue scale. RESULTS: Average ratings of general stress and symptom-related distress decreased from pre- to post-session for all eight sessions, although not all differences were statistically significant. There was no increase in general stress, or symptom-related distress across any session. CONCLUSIONS: There was evidence of positive effects and no evidence of any harmful effects arising from people with psychotic symptoms taking part in a mindfulness for psychosis session.

A systematic scoping review of psychological therapies for psychosis within acute psychiatric in-patient settings.

BACKGROUND: People with psychotic disorders account for most acute admissions to psychiatric wards. Psychological therapies are a treatment adjunct to standard medication and nursing care, but the evidence base for such therapies within in-patient settings is unclear.AimsTo conduct a systematic scoping review of the current evidence base for psychological therapies for psychosis delivered within acute in-patient settings (PROSPERO: CRD42015025623). METHOD: All study designs, and therapy models, were eligible for inclusion in the review. We searched PubMed, PsycINFO, EThOS, ProQuest, conference abstracts and trial registries. RESULTS: We found 65 studies that met criteria for inclusion in the review, 21 of which were randomised controlled trials (RCTs). The majority of studies evaluated cognitive-behavioural interventions. Quality was variable across all study types. The RCTs were mostly small (n<25 in the treatment arm), and many had methodological limitations including poorly described randomisation methods, inadequate allocation concealment and non-masked outcome assessments. We found studies used a wide range of different outcome measures, and relatively few studies reported affective symptoms or recovery-based outcomes. Many studies described adaptations to treatment delivery within in-patient settings, including increased frequency of sessions, briefer interventions and use of single-session formats. CONCLUSIONS: Based on these findings, there is a clear need to improve methodological rigour within in-patient research. Interpretation of the current evidence base is challenging given the wide range of different therapies, outcome measures and models of delivery described in the literature.Declaration of interestNone.

Delayed discharge in inpatient psychiatric care: a systematic review.

BACKGROUND: Delayed discharge is problematic. It is financially costly and can create barriers to delivering best patient care, by preventing return to usual functioning and delaying admissions of others in need. This systematic review aimed to collate existing evidence on delayed discharge in psychiatric inpatient settings and to develop understanding of factors and outcomes of delays in these services. METHODS: A search of relevant literature published between 2002 and 2022 was conducted on Pubmed, PsycInfo and Embase. Studies of any design, which published data on delayed discharge from psychiatric inpatient care in high income countries were included. Studies examining child and adolescent, general medical or forensic settings were excluded. A narrative synthesis method was utilised. Quality of research was appraised using the Mixed Methods Appraisal Tool (MMAT). RESULTS: Eighteen studies from England, Canada, Australia, Ireland, and Norway met the inclusion criteria. Six main reasons for delayed discharge were identified: (1) accommodation needs, (2) challenges securing community or rehabilitation support, (3) funding difficulties, (4) family/carer factors, (5) forensic considerations and (6) person being out of area. Some demographic and clinical factors were also found to relate to delays, such as having a diagnosis of schizophrenia or other psychotic disorder, cognitive impairment, and increased service input prior to admission. Being unemployed and socially isolated were also linked to delays. Only one study commented on consequences of delays for patients, finding they experienced feelings of lack of choice and control. Four studies examined consequences on services, identifying high financial costs. CONCLUSION: Overall, the findings suggest there are multiple interlinked factors relevant in delayed discharge that should be considered in practice and policy. Suggestions for future research are discussed, including investigating delayed discharge in other high-income countries, examining delayed discharge from child and forensic psychiatric settings, and exploring consequences of delays on patients and staff. We suggest that future research be consistent in terms used to define delayed discharge, to enhance the clarity of the evidence base. REVIEW REGISTRATION NUMBER ON PROSPERO: 292515. DATE OF REGISTRATION: 9th December 2021.

IntEgrating Smoking Cessation treAtment into usual online Psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital).

BACKGROUND: In the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available. This novel study aims to assess the acceptability and feasibility of an online smoking cessation intervention, and trial procedures, offered alongside online mental health treatment as it offers increased reach to people with common mental health difficulties who smoke. METHODS: A two-armed; Intervention (Integrated SilverCloud smoking cessation support) and control group (SilverCloud usual care), pragmatic, randomised controlled feasibility trial. We aim to recruit 500 adult smokers eligible for online mental health treatment. Follow-up will be conducted at 3-months and 6-months. We will assess the acceptability and feasibility of the trial procedures (i.e., recruitment, data completeness, self-reported acceptability and satisfaction) and the intervention (i.e., self-reported quit attempt, engagement with the smoking cessation and mental health programs, smoking cessation medicine and e-cigarette use, self-reported acceptability and satisfaction) and pilot clinical outcomes (i.e., biologically validated smoking abstinence, anxiety, depression, quality of health). CONCLUSION: If the Trial is successful, a randomised controlled effectiveness trial will follow to examine whether integrated smoking cessation and mental health treatment increases smoking abstinence and improves depression and anxiety compared to usual care. TRIAL REGISTRATION: ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149), 02/02/2023.

Mindfulness for voices: An experimental analogue study of the effect of manipulating response style to simulated voices in a non-clinical population.

OBJECTIVES: We aimed to investigate the effects of directly manipulating response style to simulated voice hearing on emotional and cognitive outcomes in a non-clinical population. DESIGN: A between-subjects design with one independent variable, response style (with two levels: mindful acceptance vs attentional avoidance). The dependent variables were subjective distress and anxiety (primary outcomes) and performance on a sustained attention task (secondary outcomes). METHODS: Participants were randomly assigned to one of two response styles (mindful acceptance vs. attentional avoidance). They completed a computerised attention task (continuous performance task) whilst listening to a simulation of voice hearing. Participants rated their experience of anxiety and distress before and after completing the sustained attention task which was used to measure their accuracy and response times. RESULTS: One hundred and one participants took part (mindful acceptance (n = 54); attentional avoidance (n = 47)). There were no statistically significant group differences on post-test distress and anxiety scores, correct response rate or response times on the computerised attention task. Participants reported a range of different response styles along the spectrum of avoidance to acceptance, but this had no association with their assigned experimental condition. Adherence to task instructions was therefore low. CONCLUSIONS: We are unable to conclude from this study whether experimentally inducing people to respond to voices under cognitively demanding conditions in an avoidant or accepting way has an impact on their emotional or cognitive outcomes. Further research should focus on the development of more robust and reliable procedures for inducing differences in response style under experimental conditions.

International rates of receipt of psychological therapy for psychosis and schizophrenia: systematic review and meta-analysis.

BACKGROUND: International clinical practice guidelines commonly recommend the provision of psychological therapies for psychosis and schizophrenia as an adjunct to medication. However, access to recommended therapies in routine clinical practice is limited. The aim of this review was to synthesise the available data on the provision of recommended psychological therapies for psychosis and schizophrenia across international mental health systems. METHODS: Electronic databases (PsychINFO, Pubmed and EMBASE) were searched for audits, service evaluation projects, or surveys, which reported data on rates of offer or receipt of any recommended psychological therapy or therapeutic intervention as part of routine clinical care. RESULTS: Twenty-two eligible studies from 9 countries were identified (N participants = 79,407). The most commonly recommended therapies in national guidelines were Cognitive-Behavioural Therapy for Psychosis (CBTp) and Family Interventions (FI). The overall pooled prevalence of rate of receipt of CBTp was 24% [95% CI 0.15-0.32] based on 15 studies (N = 42,494), with a higher rate of receipt of therapy found when pooling data from Early Intervention services only (41% [95% CI 0.21-0.60], 6 studies, N = 11,068). The overall pooled prevalence of rate of receipt of FI was 30% [95% CI 0.22-0.37] based on 14 studies (N = 13,863). CONCLUSIONS: Overall rates of receipt of recommended psychological therapies for psychosis were low across the 9 countries data were available for in this review. However, there were high rates of heterogeneity across studies, meaning that pooled estimates should be interpreted with caution. Sources of heterogeneity included different service settings (e.g. early intervention vs. non-early intervention services), and varying methods used to collect the data (e.g. audit of electronic health records vs. self-report etc.). There were no available data from the continents of South America, Asia, or Africa, meaning that a truly global picture of provision of psychological therapies for psychosis and schizophrenia is currently lacking.

User-Centered Development of STOP (Successful Treatment for Paranoia): Material Development and Usability Testing for a Digital Therapeutic for Paranoia.

BACKGROUND: Paranoia is a highly debilitating mental health condition. One novel intervention for paranoia is cognitive bias modification for paranoia (CBM-pa). CBM-pa comes from a class of interventions that focus on manipulating interpretation bias. Here, we aimed to develop and evaluate new therapy content for CBM-pa for later use in a self-administered digital therapeutic for paranoia called STOP ("Successful Treatment of Paranoia"). OBJECTIVE: This study aimed to (1) take a user-centered approach with input from living experts, clinicians, and academics to create and evaluate paranoia-relevant item content to be used in STOP and (2) engage with living experts and the design team from a digital health care solutions company to cocreate and pilot-test the STOP mobile app prototype. METHODS: We invited 18 people with living or lived experiences of paranoia to create text exemplars of personal, everyday emotionally ambiguous scenarios that could provoke paranoid thoughts. Researchers then adapted 240 suitable exemplars into corresponding intervention items in the format commonly used for CBM training and created 240 control items for the purpose of testing STOP. Each item included newly developed, visually enriching graphics content to increase the engagement and realism of the basic text scenarios. All items were then evaluated for their paranoia severity and readability by living experts (n=8) and clinicians (n=7) and for their item length by the research team. Items were evenly distributed into six 40-item sessions based on these evaluations. Finalized items were presented in the STOP mobile app, which was co-designed with a digital health care solutions company, living or lived experts, and the academic team; user acceptance was evaluated across 2 pilot tests involving living or lived experts. RESULTS: All materials reached predefined acceptable thresholds on all rating criteria: paranoia severity (intervention items: ≥1; control items: ≤1, readability: ≥3, and length of the scenarios), and there was no systematic difference between the intervention and control group materials overall or between individual sessions within each group. For item graphics, we also found no systematic differences in users' ratings of complexity (P=.68), attractiveness (P=.15), and interest (P=.14) between intervention and control group materials. User acceptance testing of the mobile app found that it is easy to use and navigate, interactive, and helpful. CONCLUSIONS: Material development for any new digital therapeutic requires an iterative and rigorous process of testing involving multiple contributing groups. Appropriate user-centered development can create user-friendly mobile health apps, which may improve face validity and have a greater chance of being engaging and acceptable to the target end users.

Reasoning bias and belief conviction in obsessive-compulsive disorder and delusions: jumping to conclusions across disorders?

OBJECTIVES: This study investigated whether a reasoning bias ('jumping to conclusions'; JTC) found to be associated with higher levels of conviction in delusions is also associated with high-conviction beliefs in obsessive-compulsive disorder (OCD). DESIGN: The experimental design was mixed-effects, with one between-subjects factor of group and one within-subjects factor of task. METHODS: Participants were 16 people with high-conviction OCD (≥ 50%), 16 people with low-conviction OCD (< 50%), 16 people with delusions (≥ 50% conviction), and 16 non-clinical controls. JTC was assessed using a neutral probabilistic reasoning task (beads task) and a version involving words of differing emotional salience (words task). RESULTS: There was no statistically significant difference in draws to decision on the beads task between the high-conviction OCD group, the low-conviction OCD group, and the non-clinical controls. The delusions group made significantly fewer draws to decision compared to the non-clinical controls on the words task but not the beads task and significantly fewer draws on both tasks compared with the combined OCD group. Emotionally salient material (words task) did not affect draws to decision in any group. CONCLUSIONS: JTC is associated with delusions but not high-conviction beliefs in OCD. The cognitive processes associated with high-conviction beliefs in OCD and psychosis may not be trans-diagnostic. This is consistent with the view that high-conviction OCD should not be classified as a psychotic disorder.

Kintsugi-Identity change and reconstruction following an episode of psychosis: A systematic review and thematic synthesis.

AIM: Research has shown that experiences of psychosis can have a significant impact on an individual's identity. Moreover, the way those who experience psychosis make sense of these changes appears to affect their recovery journey and hold clinical significance. However, this area of research is still very much developing, and there is a need for reviews, which look to synthesise and understand this process of identity change to guide clinicians working in this area as well as future research. This study looks to meet that gap and aims to synthesise qualitative literature exploring the lived experience of identity change amongst people who experience psychosis. METHODS: A systematic review using thematic synthesis was carried out. The PRISMA and ENTREQ guidelines were followed in reporting the study. RESULTS: Ninety-one papers were identified which met criteria for inclusion and 31 papers included in the synthesis at which point conceptual saturation was judged to have been reached. Five themes were created: psychosis as an obliteration of the old self; the futile fight against psychosis; mourning for who I was; the battle for self as a battle against disempowerment; and recovery as rebirth. CONCLUSIONS: Results highlighted the substantive impact an experience of psychosis has on an individual's identity, the key role sense making around these identity changes plays in recovery and the crucial impact of clinicians on the sense-making process. The implications for theory, future research and clinical practice are discussed.

A systematic review and meta-analysis of the association between emotional stress reactivity and psychosis.

AIM: Emotional stress reactivity may be a mediating factor in the association between trauma and psychosis. This review aimed to (i) identify, summarise and critically evaluate the link between emotional stress reactivity and psychotic experiences (ii) examine evidence for a 'dose-response' relationship between stress reactivity and psychosis in the wider psychosis phenotype (i.e., sub-clinical symptoms). METHODS: Electronic database searches (PsychINFO, MEDLINE, EMBASE) were conducted for studies which investigated the link between stress reactivity and psychosis, psychotic symptoms, or a vulnerability to developing psychosis (wider phenotype). Cross-sectional, experimental and experience sampling method study designs were eligible for inclusion. RESULTS: Fourty five eligible articles were identified (N participants = 8830). Narrative synthesis showed that increased emotional stress reactivity was associated with psychosis and subclinical psychotic experiences across all study designs, however, findings were inconsistent across studies. The preliminary meta-analysis (k = 4, n = 383) showed increases in emotional stress reactivity was associated with higher negative affect in response to event-related stress, in those with psychosis compared to controls (mean difference in beta coefficients = 0.05, 95% CI 0.02-0.08, p = .004). However, this difference was small with a considerable degree of heterogeneity (p = .001, I2  = 81%) so results should be interpreted with caution. CONCLUSIONS: Overall, the evidence suggests that there is a link between emotional stress reactivity and psychosis in those with psychosis, those at high risk of developing psychosis and in relation to subclinical psychotic-like experiences in the general population.

Recruiting and retaining participants in three randomised controlled trials of psychological interventions conducted on acute psychiatric wards: top ten tips for success.

BACKGROUND: It is essential to conduct randomised controlled trials of psychological interventions on acute psychiatric wards to build a robust evidence base for clinical practice. AIMS: This paper aims to share strategies from three different in-patient trials that successfully recruited and retained participants, to disseminate good practice for the conduct of future trials in this challenging and complex clinical setting. METHOD: We present strategies from three in-patient trials of psychological interventions: TULIPS (Talk, Understand, Listen for Inpatient Settings), amBITION (Brief Talking Therapies on Wards) and INSITE (Inpatient Suicide Intervention and Therapy Evaluation). All studies recruited participants from acute in-patient wards, initiated therapy within the in-patient setting and followed up on participants post-discharge. RESULTS: We summarise our recommendations for good practice in the form of ten top tips for success, based on our collective experience of conducting trials on psychiatric wards. Key themes relate to the importance of relationships between the research team and clinical staff; good stakeholder involvement and getting early buy-in from the team; and adapting to the particular demands of the clinical setting. CONCLUSIONS: Sharing good practice recommendations can help reduce research waste arising from poor recruitment and/or retention in future in-patient clinical trials.

Home practice in mindfulness-based interventions for psychosis groups: a systematic review and qualitative study.

BACKGROUND: Regular home practice is considered a core component of mindfulness groups and may be associated with better treatment outcomes. This study aimed to (1) review the existing evidence on how much home practice people do in mindfulness-based interventions for psychosis groups, and (2) explore participants' experiences of the barriers and facilitators to completing home practice in a mindfulness for psychosis group using a qualitative study. METHODS: In study 1, we conducted a systematic review of mindfulness-based interventions for psychosis studies and extracted data on home practice rates. In study 2, we conducted semi-structured interviews with people who had completed a mindfulness for psychosis group (N = 5) as part of their routine community care, specifically focusing on experiences of home practice. RESULTS: Out of 43 studies included in the systematic review, only 5 reported any data on amount of home practice, and none examined the relationship between completion of home practice and treatment outcomes. In the qualitative study, participants described home practice as being difficult but important. Arising themes were similar to findings from previous (non-psychosis) studies suggesting that generic challenges are common, rather than being specific to psychosis. CONCLUSIONS: We recommend that future mindfulness-based interventions for psychosis studies record data on home practice rates, in order to investigate any association between home practice and treatment outcome. Our qualitative findings suggest home practice can be a valued part of mindfulness for psychosis group, and a normalising approach could be taken when and if participants encounter common challenges.

Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis.

Objective: To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition. Design: Cross sectional analysis. Setting: US and Europe. Population: Sample of core outcome sets related to drugs, devices, and gene therapy that involved patients in the consensus process, published between 1 January 2015 and 31 December 2019; and corresponding EMA and FDA guidance documents. Main outcome measures: The extent of matches between outcomes included within core outcome sets and those recommended in corresponding EMA and FDA guidance documents were assessed. Matches were considered to be general (ie, non-specific) or specific (ie, exact). General matches were assessed to determine whether the core outcome set or guidance document outcome was narrower. Results: Relevant guidance documents were found for for 38 (39%) of 98 eligible published core outcome sets. Among outcomes in core outcome sets, medians of 70% (interquartile range 48-86%) and 52% (33-77%) were matches with outcomes recommended in EMA and FDA documents, respectively. Medians of 46% (27-68%) and 26% (18-46%) were specific matches with outcomes in EMA and FDA documents, respectively. When outcomes were generally matched, the outcomes from core outcome sets were more frequently narrower than the regulatory outcomes (83% and 75% for EMA and FDA, respectively). Conclusion: Greater adoption of, and reference to, core outcome sets in regulatory guidance documents can encourage clinical trialists, especially those in industry, to measure and report consistent and agreed outcomes and improve the quality of guidance. Given the overlap between outcomes in core outcome sets and regulatory guidance, and given that most core outcome sets now involve patients in the consensus process, these sets could serve as a useful resource for regulators when recommending outcomes for studies evaluating regulated products. Developers are encouraged to appraise recommended outcomes in salient regulatory documents when planning a core outcome set.