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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Use of core outcome sets was low in clinical trials published in major medical journals.

OBJECTIVES: To examine current practices in late-phase trials published in major medical journals and examine trialists' views about core outcome set (COS) use. STUDY DESIGN AND SETTING: A sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS. RESULTS: Ninety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%). CONCLUSION: COS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.

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.

Representation of published core outcome sets for research in regulatory guidance: protocol.

Background: The COMET Initiative promotes the development and use of 'core outcome sets' (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents which match in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in EMA and FDA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. If the findings of this study reveal a lack of concordance between COS and regulatory guidance overall or for particular disease areas, we will invite feedback from FDA and EMA and will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

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.

Who gets evidence-based therapy for psychosis following a psychiatric hospital admission? Follow-up data from an inpatient randomised controlled trial.

A major barrier to clinicians referring service users with psychosis for psychological therapies is the belief that they will not engage. We investigated therapy receipt after discharge, in a sample of service users who had already demonstrated willingness to engage in psychological therapy during an inpatient admission. Only one-third of service users (33%; 16/48) received at least 1 session of evidence-based therapy at 6-month follow-up after discharge. Therapy receipt was more common for service users with (i) lower delusional distress at discharge, (ii) Black and Minority Ethnic (BME) background, and (iii) discharged to an Early Intervention (EI) service.

Mindfulness for psychosis groups; description and preliminary evaluation of a novel routine care pathway in Hong Kong.

BACKGROUND: There is no current guidance on where Mindfulness for Psychosis groups should best be situated within care pathways. The objectives of this paper are to (1) describe a novel care pathway tested out in a psychiatric outpatient service in Hong Kong, and (2) to present feasibility outcomes on attendance and drop-out, and routine clinical outcomes. METHODS: A new mindfulness pathway was set up, for service users with psychosis who had first completed a course of Cognitive Behavioural Therapy for psychosis (CBTp). After attending an orientation 'taster' session, service users could then attended a 4-session weekly Mindfulness for Psychosis group, followed by optional monthly follow-up sessions. RESULTS: A high proportion of service users referred into the pathway (19/22; 86%) went on to attend a Mindfulness for Psychosis group after attending an orientation 'taster' session. Attendance at group sessions was high, with all participants attending at least 2/4 group sessions, and no drop-outs. Attendance at monthly follow-up groups was also high, with 84% (16/19) attending at least one monthly follow-up. Routine clinical outcome data showed a reduction in negative symptoms of psychosis, and an increase in mindfulness and mindful responding in daily life, from pre- to post group. CONCLUSIONS: Offering service users with psychosis the opportunity to attend a mindfulness for psychosis group after completing a course of CBTp was highly acceptable, as evidenced by high attendance, and low drop-out. Possible benefits in terms of improving negative symptoms may be particularly important in promoting recovery through improved everyday functioning.