Implementing and Evaluating a National Integrated Digital Registry and Clinical Decision Support System in Early Intervention in Psychosis Services (Early Psychosis Informatics Into Care): Co-Designed Protocol.

BACKGROUND: Early intervention in psychosis (EIP) services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems (CDSSs) have revolutionized the delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. OBJECTIVE: This paper reports the protocol for the program development phase of this study, in which we aimed to co-design and produce an evidence-based, stakeholder-informed framework for the building, implementation, piloting, and evaluation of a national integrated digital registry and CDSS for psychosis, known as EPICare (Early Psychosis Informatics into Care). METHODS: We conducted 3 concurrent work packages, with reciprocal knowledge exchange between each. In work package 1, using a participatory co-design framework, key stakeholders (clinicians, academics, policy makers, and patient and public contributors) engaged in 4 workshops to review, refine, and identify a core set of essential and desirable measures and features of the EPICare registry and CDSS. Using a modified Delphi approach, we then developed a consensus of data priorities. In work package 2, we collaborated with National Health Service (NHS) informatics teams to identify relevant data currently captured in electronic health records, understand data retrieval methods, and design the software architecture and data model to inform future implementation. In work package 3, observations of stakeholder workshops and individual interviews with representative stakeholders (n=10) were subject to interpretative qualitative analysis, guided by normalization process theory, to identify factors likely to influence the adoption and implementation of EPICare into routine practice. RESULTS: Stage 1 of the EPICare study took place between December 2021 and September 2022. The next steps include stage 2 building, piloting, implementation, and evaluation of EPICare in 5 demonstrator NHS Trusts serving underserved and diverse populations with substantial need for EIP care in England. If successful, this will be followed by stage 3, in which we will seek NHS adoption of EPICare for rollout to all EIP services in England. CONCLUSIONS: By establishing a multistakeholder network and engaging them in an iterative co-design process, we have identified essential and desirable elements of the EPICare registry and CDSS; proactively identified and minimized potential challenges and barriers to uptake and implementation; and addressed key questions related to informatics architecture, infrastructure, governance, and integration in diverse NHS Trusts, enabling us to proceed with the building, piloting, implementation, and evaluation of EPICare. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50177.

A crisis planning and monitoring intervention to reduce compulsory hospital readmissions (FINCH study): protocol for a randomised controlled feasibility study.

BACKGROUND: Rates of compulsory (also known as involuntary) detention under mental health legislation have been rising over several decades in countries including England. Avoiding such detentions should be a high priority given their potentially traumatic nature and departure from usual ethical principles of consent and collaboration. Those who have been detained previously are at high risk of being detained again, and thus a priority group for preventive interventions. In a very sparse literature, interventions based on crisis planning emerge as having more supporting evidence than other approaches to preventing compulsory detention. METHOD: We have adapted and manualised an intervention previously trialled in Zürich Switzerland, aimed at reducing future compulsory detentions among people being discharged following a psychiatric admission that has included a period of compulsory detention. A co-production group including people with relevant lived and clinical experience has co-designed the adaptations to the intervention, drawing on evidence on crisis planning and self-management and on qualitative interviews with service users and clinicians. We will conduct a randomised controlled feasibility trial of the intervention, randomising 80 participants to either the intervention in addition to usual care, or usual care only. Feasibility and acceptability of the intervention and trial procedures will be assessed through process evaluation (including rates of randomisation, recruitment, and retention) and qualitative interviews. We will also assess and report on planned trial outcomes. The planned primary outcome for a full trial is repeat compulsory detention within one year of randomisation, and secondary outcomes include compulsory detention within 2 years, and symptoms, service satisfaction, self-rated recovery, self-management confidence, and service engagement. A health economic evaluation is also included. DISCUSSION: This feasibility study, and any subsequent full trial, will add to a currently limited literature on interventions to prevent involuntary detention, a goal valued highly by service users, carers, clinicians, and policymakers. There are significant potential impediments to recruiting and retaining this group, whose experiences of mental health care have often been negative and traumatising, and who are at high risk of disengagement. TRIAL REGISTRATION: ISRCTN, ISRCTN11627644. Registered 25th May 2022, https://www.isrctn.com/ISRCTN11627644 .

Evaluating mental health decision units in acute care pathways (DECISION): a quasi-experimental, qualitative and health economic evaluation.

Background: People experiencing mental health crises in the community often present to emergency departments and are admitted to a psychiatric hospital. Because of the demands on emergency department and inpatient care, psychiatric decision units have emerged to provide a more suitable environment for assessment and signposting to appropriate care. Objectives: The study aimed to ascertain the structure and activities of psychiatric decision units in England and to provide an evidence base for their effectiveness, costs and benefits, and optimal configuration. Design: This was a mixed-methods study comprising survey, systematic review, interrupted time series, synthetic control study, cohort study, qualitative interview study and health economic evaluation, using a critical interpretive synthesis approach. Setting: The study took place in four mental health National Health Service trusts with psychiatric decision units, and six acute hospital National Health Service trusts where emergency departments referred to psychiatric decision units in each mental health trust. Participants: Participants in the cohort study (n = 2110) were first-time referrals to psychiatric decision units for two 5-month periods from 1 October 2018 and 1 October 2019, respectively. Participants in the qualitative study were first-time referrals to psychiatric decision units recruited within 1 month of discharge (n = 39), members of psychiatric decision unit clinical teams (n = 15) and clinicians referring to psychiatric decision units (n = 19). Outcomes: Primary mental health outcome in the interrupted time series and cohort study was informal psychiatric hospital admission, and in the synthetic control any psychiatric hospital admission; primary emergency department outcome in the interrupted time series and synthetic control was mental health attendance at emergency department. Data for the interrupted time series and cohort study were extracted from electronic patient record in mental health and acute trusts; data for the synthetic control study were obtained through NHS Digital from Hospital Episode Statistics admitted patient care for psychiatric admissions and Hospital Episode Statistics Accident and Emergency for emergency department attendances. The health economic evaluation used data from all studies. Relevant databases were searched for controlled or comparison group studies of hospital-based mental health assessments permitting overnight stays of a maximum of 1 week that measured adult acute psychiatric admissions and/or mental health presentations at emergency department. Selection, data extraction and quality rating of studies were double assessed. Narrative synthesis of included studies was undertaken and meta-analyses were performed where sufficient studies reported outcomes. Results: Psychiatric decision units have the potential to reduce informal psychiatric admissions, mental health presentations and wait times at emergency department. Cost savings are largely marginal and do not offset the cost of units. First-time referrals to psychiatric decision units use more inpatient and community care and less emergency department-based liaison psychiatry in the months following the first visit. Psychiatric decision units work best when configured to reduce either informal psychiatric admissions (longer length of stay, higher staff-to-patient ratio, use of psychosocial interventions), resulting in improved quality of crisis care or demand on the emergency department (higher capacity, shorter length of stay). To function well, psychiatric decision units should be integrated into the crisis care pathway alongside a range of community-based support. Limitations: The availability and quality of data imposed limitations on the reliability of some analyses. Future work: Psychiatric decision units should not be commissioned with an expectation of short-term financial return on investment but, if appropriately configured, they can provide better quality of care for people in crisis who would not benefit from acute admission or reduce pressure on emergency department. Study registration: The systematic review was registered on the International Prospective Register of Systematic Reviews as CRD42019151043. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/49/70) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 25. See the NIHR Funding and Awards website for further award information.

People who experience mental health crises often go to a hospital emergency department and can be admitted to a psychiatric hospital. Emergency departments and psychiatric wards are not always the best environments for supporting people in a crisis. Emergency departments are overcrowded and waits can be very long; psychiatric wards are also very busy. Psychiatric decision units have been introduced to reduce pressure and improve experiences of crisis care. Psychiatric decision units are short-stay hospital-based units where people can be assessed and signposted to the most appropriate care. This study aimed to evaluate the effect of psychiatric decision units on emergency department visits, psychiatric admissions and the cost of mental health care, and to consider the best way for psychiatric decision units to be structured. We looked at research on similar units internationally and identified all psychiatric decision units in England. We evaluated the impact of psychiatric decision units four mental health NHS trusts on emergency department visits and psychiatric admissions by examining electronic patient records in the 2 years before and after units opened, and by comparing records in areas with and without psychiatric decision units using data from NHS Digital. We compared mental health services used by people in the 9 months before and after their first psychiatric decision unit stay. We interviewed people about their experiences of the psychiatric decision unit and crisis care. We also interviewed staff working on and referring people to psychiatric decision units. There were some reductions in psychiatric admissions, emergency department visits and wait times following opening of psychiatric decision units. The resulting cost savings were small and did not outweigh the costs of running psychiatric decision units. People mostly found units safe, calming and supportive, except where they were discharged too quickly. Psychiatric decision units worked best to reduce psychiatric admissions and improve quality of crisis care where stays were longer and staffing levels higher. Psychiatric decision units had more impact on emergency departments where they were larger and stays were shorter.

Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment-resistant depression in secondary community mental health services: trial protocol.

BACKGROUND: New treatments are needed for people with treatment-resistant depression (TRD), who do not benefit from anti-depressants and many of whom do not recover fully with psychological treatments. The Community Navigator programme was co-produced with service users and practitioners. It is a novel social intervention which aims to reduce loneliness and thus improve health outcomes for people with TRD. Participants receive up to 10 individual meetings with a Community Navigator, who helps them to map their social world and set and enact goals to enhance their social connections and reduce loneliness. Participants may also access group meet-ups with others in the programme every 2 months, and may be offered modest financial support to enable activities to support social connections. METHODS: A researcher-blind, multi-site, 1:1 randomised controlled trial with N = 306 participants will test the effectiveness of the Community Navigator programme for people with TRD in secondary community mental health teams (CMHTs). Our primary hypothesis is that people who are offered the Community Navigator programme as an addition to usual CMHT care will be less depressed, assessed using the PHQ-9 self-report measure, at 8-month, end-of-treatment follow-up, compared to a control group receiving usual CMHT care and a booklet with information about local social groups and activities. We will follow participants up at end-of-treatment and at 14 months, 6 months after end-of-treatment follow-up. Secondary outcomes include the following: loneliness, anxiety, personal recovery, self-efficacy, social network, social identities. We will collect data about health-related quality of life and service use to investigate the cost-effectiveness of the Community Navigator programme. DISCUSSION: This trial will provide definitive evidence about the effectiveness and cost-effectiveness of the Community Navigator programme and whether it can be recommended for use in practice. The trial is due to finish in August 2025. TRIAL REGISTRATION: Prospectively registered on 8th July 2022 at: ISRCTN13205972.

Cost-effectiveness of peer-supported self-management for people discharged from a mental health crisis team: methodological challenges and recommendations.

Background: Mental health acute crisis episodes are associated with high inpatient costs. Self-management interventions may reduce readmission by enabling individuals to manage their condition. Delivery of such interventions by Peer Support Workers (PSWs) may be cost-effective. CORE, a randomized control trial of a PSW self-management intervention compared to usual care, found a significant reduction in admissions to acute mental healthcare for participants receiving the intervention. This paper aims to evaluate the cost-effectiveness of the intervention over 12 months from a mental health service perspective. Analysis methods of increasing complexity were used to account for data missingness and distribution. Methods: Participants were recruited from six crisis resolution teams in England from 12 March 2014 to 3 July 2015 (trial registration ISRCTN: 01027104). Resource use was collected from patient records at baseline and 12 months. The EQ-5D-3L was collected at baseline and 4 and 18 months, and linear interpolation was used to calculate 12-month values for quality-adjusted life-years (QALYs). The primary analysis of adjusted mean incremental costs and QALYs for complete cases are calculated separately using OLS regression. Secondly, a complete-case non-parametric two-stage bootstrap (TSB) was performed. The impacts of missing data and skewed cost data were explored using multiple imputation using chained equations and general linear models, respectively. Results: Four hundred and forty-one participants were recruited to CORE; 221 randomized to the PSW intervention and 220 to usual care plus workbook. The probability that the PSW intervention was cost-effective compared with the workbook plus usual care control at 12 months varied with the method used, and ranged from 57% to 96% at a cost-effectiveness threshold of £20,000 per QALY gained. Discussion: There was a minimum 57% chance that the intervention was cost-effective compared to the control using 12-month costs and QALYs. The probability varied by 40% when methods were employed to account for the relationship between costs and QALYs, but which restricted the sample to those who provided both complete cost and utility data. Caution should therefore be applied when selecting methods for the evaluation of healthcare interventions that aim to increase precision but may introduce bias if missing data are heavily unbalanced between costs and outcomes.

Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants.

BACKGROUND AND HYPOTHESIS: Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes. STUDY DESIGN: A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles. STUDY RESULTS: We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen's d: 0.07, -0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment. CONCLUSIONS: Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation. TRIAL REGISTRATION: ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.

Acceptability and feasibility of using contingency management for cannabis reduction in specialist mental health services for psychosis: A qualitative study of staff views.

AIM: There is increasing evidence linking cannabis use to onset, continuation, and relapse of psychosis. Contingency Management (CM) is discussed as a candidate intervention to reduce cannabis use. Our study aimed to explore staff views on the feasibility and acceptability of using CM for cannabis reduction in early intervention services for psychosis (EIS), in order to inform wider learning about implementation of such approaches in mental health services. SETTING: EIS teams in England. METHOD: Semi-structured interviews and focus groups analysed thematically. PARTICIPANTS: Forty managers and staff members working in mental health services where a CM intervention was delivered as part of a trial, four staff who delivered CM in these settings, and three key informants (academic experts in relevant fields). INTERVENTION: A complex intervention comprising CM with incremental financial incentives (vouchers) for reducing or stopping cannabis use, and psychoeducation about the risks of cannabis use. FINDINGS: Acceptability appeared to depend on how well the intervention was seen to fit with the service setting and ethos. Concerns included who should deliver CM; potential impacts on the therapeutic relationship; the ethics of using incentives to reduce socially objectionable behaviours; and how CM fits with the work of mental health practitioners. Feasibility concerns centred on resource limitations including time, cost, training, and national guidance and commissioning. CONCLUSIONS: Staff attitudes are likely to be a crucial influence on successful implementation of contingency management for cannabis reduction in specialist mental health settings. Several contextual barriers would need to be overcome to increase the acceptability of the intervention for use in early intervention services for psychosis.

Clinician perspectives on what constitutes good practice in community services for people with complex emotional needs: A qualitative thematic meta-synthesis.

INTRODUCTION: The need to improve the quality of community mental health services for people with Complex Emotional Needs (CEN) (who may have a diagnosis of 'personality disorder') is recognised internationally and has become a renewed policy priority in England. Such improvement requires positive engagement from clinicians across the service system, and their perspectives on achieving good practice need to be understood. AIM: To synthesise qualitative evidence on clinician perspectives on what constitutes good practice, and what helps or prevents it being achieved, in community mental health services for people with CEN. METHODS: Six bibliographic databases were searched for studies published since 2003 and supplementary citation tracking was conducted. Studies that used any recognised qualitative method and reported clinician experiences and perspectives on community-based mental health services for adults with CEN were eligible for this review, including generic and specialist settings. Meta-synthesis was used to generate and synthesise over-arching themes across included studies. RESULTS: Twenty-nine papers were eligible for inclusion, most with samples given a 'personality disorder' diagnosis. Six over-arching themes were identified: 1. The use and misuse of diagnosis; 2. The patient journey into services: nowhere to go; 3. Therapeutic relationships: connection and distance; 4. The nature of treatment: not doing too much or too little; 5. Managing safety issues and crises: being measured and proactive; 6. Clinician and wider service needs: whose needs are they anyway? The overall quality of the evidence was moderate. DISCUSSION: Through summarising the literature on clinician perspectives on good practice for people with CEN, over-arching priorities were identified on which there appears to be substantial consensus. In their focus on needs such as for a long-term perspective on treatment journeys, high quality and consistent therapeutic relationships, and a balanced approach to safety, clinician priorities are mainly congruent with those found in studies on service user views. They also identify clinician needs that should be met for good care to be provided, including for supervision, joint working and organisational support.

Effectiveness and cost-effectiveness of psychiatric mother and baby units: quasi-experimental study.

BACKGROUND: Psychiatric mother and baby units (MBUs) are recommended for severe perinatal mental illness, but effectiveness compared with other forms of acute care remains unknown. AIMS: We hypothesised that women admitted to MBUs would be less likely to be readmitted to acute care in the 12 months following discharge, compared with women admitted to non-MBU acute care (generic psychiatric wards or crisis resolution teams (CRTs)). METHOD: Quasi-experimental cohort study of women accessing acute psychiatric care up to 1 year postpartum in 42 healthcare organisations across England and Wales. Primary outcome was readmission within 12 months post-discharge. Propensity scores were used to account for systematic differences between MBU and non-MBU participants. Secondary outcomes included assessment of cost-effectiveness, experience of services, unmet needs, perceived bonding, observed mother-infant interaction quality and safeguarding outcome. RESULTS: Of 279 women, 108 (39%) received MBU care, 62 (22%) generic ward care and 109 (39%) CRT care only. The MBU group (n = 105) had similar readmission rates to the non-MBU group (n = 158) (aOR = 0.95, 95% CI 0.86-1.04, P = 0.29; an absolute difference of -5%, 95% CI -14 to 4%). Service satisfaction was significantly higher among women accessing MBUs compared with non-MBUs; no significant differences were observed for any other secondary outcomes. CONCLUSIONS: We found no significant differences in rates of readmission, but MBU advantage might have been masked by residual confounders; readmission will also depend on quality of care after discharge and type of illness. Future studies should attempt to identify the effective ingredients of specialist perinatal in-patient and community care to improve outcomes.

Interventions to improve social circumstances of people with mental health conditions: a rapid evidence synthesis.

BACKGROUND: Poor social circumstances can induce, exacerbate and prolong symptoms of mental health conditions, while having a mental health condition can also lead to worse social outcomes. Many people with mental health conditions prioritise improvement in social and functional outcomes over reduction in clinical symptoms. Interventions that improve social circumstances in this population should thus be considered a priority for research and policy. METHODS: This rapid evidence synthesis reports on randomised controlled trials of interventions to improve social circumstances across eight social domains (Housing and homelessness; money and basic needs; work and education; social isolation and connectedness; family, intimate and caring relationships; victimisation and exploitation; offending; and rights, inclusion and citizenship) in people with mental health conditions. Economic evaluations were also identified. A comprehensive, stepped search approach of the Cochrane library, MEDLINE, Embase, PsycINFO, Web of Science and Scopus was conducted. RESULTS: One systematic review and 102 randomised controlled trials were included. We did not find RCT evidence for interventions to improve family, intimate and caring relationships and only one or two trials for each of improving money and basic needs, victimisation and exploitation, and rights, inclusion and citizenship. Evidence from successful interventions in improving homelessness (Housing First) and employment (Individual Placement and Support) suggests that high-intensity interventions which focus on the desired social outcome and provide comprehensive multidisciplinary support could influence positive change in social circumstances of people with mental health conditions. Objective social isolation could be improved using a range of approaches such as supported socialisation and social skills training but interventions to reduce offending showed few benefits. Studies with cost and cost-effectiveness components were generally supportive of interventions to improve housing and vocational outcomes. More research is needed to ensure that social circumstances accompanied by high risks of further exacerbation of mental health conditions are adequately addressed. CONCLUSIONS: Although there is a large body of literature examining how to support some aspects of life for people with mental health conditions, more high-quality evidence is required in other social domains. Integration into mental health services of interventions targeting social circumstances could significantly improve a number of social outcomes.

Service user perspectives of community mental health services for people with complex emotional needs: a co-produced qualitative interview study.

BACKGROUND: There is consensus that services supporting people with complex emotional needs are part of a mental health care system in which change is needed. To date, service users' views and co-production initiatives have had little impact on the development of interventions and care. This needs to change, and our paper evidences the experiences and perspectives of a diverse range of people on how community services can best address the needs of people with complex emotional needs. METHODS: A co-produced qualitative research study. Lived experience researchers led data collection and analysis. Individual interviews were conducted with 30 people across England who had a diverse range of experiences and perspectives of using community services for complex emotional needs. Participants were asked about their experiences of using community services for their mental health, and views on how community services can best address their needs. Thematic analysis was used to analyse the data. RESULTS: Participants reported some experiences of good practice but also of experiences of severely stigmatising interventions, a lack of effective support and service fragmentation. Relational Practice was identified as the central overarching theme and describes how community services can best support people with complex emotional needs. This approach involves care delivered in a non-stigmatising, individualised and compassionate way and care that is trauma-informed. It involves care that is planned collaboratively with service users to ensure their multiple needs are addressed in a flexible, holistic and consistent way which accounts for the long-term and fluctuating nature of their needs. CONCLUSIONS: Relational practice approaches have potential to facilitate better community care for people with complex emotional needs. Research and service development are needed to examine how best to implement such approaches across the mental health service system. This work must be co-produced with people with relevant lived experience, their carers and the professionals who support them.

A web-based, peer-supported self-management intervention to reduce distress in relatives of people with psychosis or bipolar disorder: the REACT RCT.

BACKGROUND: Relatives caring for people with severe mental health problems find information and emotional support hard to access. Online support for self-management offers a potential solution. OBJECTIVE: The objective was to determine the clinical effectiveness and cost-effectiveness of an online supported self-management tool for relatives: the Relatives' Education And Coping Toolkit (REACT). DESIGN AND SETTING: This was a primarily online (UK), single-blind, randomised controlled trial, comparing REACT plus a resource directory and treatment as usual with the resource directory and treatment as usual only, by measuring user distress and other well-being measures at baseline and at 12 and 24 weeks. PARTICIPANTS: A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥ 16 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited. INTERVENTION: REACT comprised 12 psychoeducation modules, peer support through a group forum, confidential messaging and a comprehensive resource directory of national support. Trained relatives moderated the forum and responded to messages. MAIN OUTCOME MEASURE: The main outcome was the level of participants' distress, as measured by the General Health Questionnaire-28 items. RESULTS: Various online and offline strategies, including social media, directed potential participants to the website. Participants were randomised to one of two arms: REACT plus the resource directory (n = 399) or the resource directory only (n = 401). Retention at 24 weeks was 75% (REACT arm, n = 292; resource directory-only arm, n = 307). The mean scores for the General Health Questionnaire-28 items reduced substantially across both arms over 24 weeks, from 40.2 (standard deviation 14.3) to 30.5 (standard deviation 15.6), with no significant difference between arms (mean difference -1.39, 95% confidence interval -3.60 to 0.83; p = 0.22). At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03; p = 0.027), but this finding is likely to be of limited clinical significance. Accounting for missing data, which were associated with higher distress in the REACT arm (0.33, 95% confidence interval -0.27 to 0.93; p = 0.279), in a longitudinal model, there was no significant difference between arms over 24 weeks (-0.56, 95% confidence interval -2.34 to 1.22; p = 0.51). REACT cost £142.95 per participant to design and deliver (£62.27 for delivery only), compared with £0.84 for the resource directory only. A health economic analysis of NHS, health and Personal Social Services outcomes found that REACT has higher costs (£286.77), slightly better General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score adjusted for baseline, age and gender: -1.152, 95% confidence interval -3.370 to 1.065) and slightly lower quality-adjusted life-year gains than the resource directory only; none of these differences was statistically significant. The median time spent online was 50.8 minutes (interquartile range 12.4-172.1 minutes) for REACT, with no significant association with outcome. Participants reported finding REACT a safe, confidential environment (96%) and reported feeling supported by the forum (89%) and the REACT supporters (86%). No serious adverse events were reported. LIMITATIONS: The sample comprised predominantly white British females, 25% of participants were lost to follow-up and dropout in the REACT arm was not random. CONCLUSIONS: An online self-management support toolkit with a moderated group forum is acceptable to relatives and, compared with face-to-face programmes, offers inexpensive, safe delivery of National Institute for Health and Care Excellence-recommended support to engage relatives as peers in care delivery. However, currently, REACT plus the resource directory is no more effective at reducing relatives' distress than the resource directory only. FUTURE WORK: Further research in improving the effectiveness of online carer support interventions is required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72019945. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 32. See the NIHR Journals Library website for further project information.

Relatives of people with severe mental health problems need better access to information and emotional support. The Relatives' Education And Coping Toolkit (REACT) is a website designed to do this. It includes lots of information presented in text and video, an online forum for relatives to share knowledge and experience, a messaging system where they can ask questions in confidence and a comprehensive directory of contact details for national organisations offering relevant support. Trained relatives support the forum and messaging. In the UK, we recruited 800 relatives of people with severe mental health problems: all were aged ≥ 16 years, had high levels of distress, had access to the internet and wanted help. We divided them into two equal groups: one group received REACT (including the resource directory), whereas the other group received the resource directory only. To ensure that there were no differences between groups at the start, relatives were allocated to the two groups randomly, so they had an equal chance of being in either group. We followed up with both groups at 12 and 24 weeks, and received data from approximately three-quarters of the participants. This trial found that REACT was acceptable, safe and inexpensive to deliver (£62.27 per relative), compared with face-to-face interventions, and that relatives using it felt well supported. However, once we accounted for missing data (relatives who dropped out of the trial or did not complete the follow-up questionnaires), there were no significant differences between the groups. There was no evidence that REACT increased relatives' quality of life or saved money for the NHS.

The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression.

BACKGROUND: Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation. METHODS: Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff. RESULTS: Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety. CONCLUSIONS: A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.

The accuracy and accessibility of cited evidence: a study examining mental health policy documents.

PURPOSE: Evidence-based policy making is increasingly being advocated by governments and scholars. To show that policies are informed by evidence, policy-related documents that cite external sources should ideally provide direct access to, and accurately represent, the referenced source and the evidence it provides. Our aim was to find a way to systematically assess the prevalence of referencing accuracy and accessibility issues in referenced statements selected from a sample of mental health-related policy documents. METHOD: 236 referenced statements were selected from 10 mental health-related policy documents published between 2013 and 2018. Policy documents were chosen as the focus of this investigation because of their relative accessibility and impact on clinical practice. Statements were rated against their referenced sources in terms of the (i) content accuracy in relation to the information provided by the referenced source and (ii) degree of accessibility of the source and the required evidence from the references provided. RESULTS: Of the 236 statements, 141 (59.7%) accurately represented the referenced source, 45 (19.1%) contained major errors and 50 (21.2%) contained minor errors in accuracy. For accessibility, 126 (53.4%) directly referenced primary sources of evidence that supported the claims made, 36 (15.3%) contained indirect references, 18 (7.6%) provided 'dead-end' references, and 11 (4.7%) references were completely inaccessible. CONCLUSIONS: With only slightly over half of all statements assessed providing fully accessible references and accurately representing the referenced source, these components of referencing quality deserve further attention if evidence-informed policy goals are to be achieved. The rating framework used in the current study proved to be a simple and straightforward method to assess these components and can provide a baseline against which interventions can be designed to improve referencing quality.

Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT.

BACKGROUND: People with serious mental illness have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health. OBJECTIVES: To develop a sexual health promotion intervention for people with serious mental illness, and to conduct a feasibility trial in order to establish the acceptability and parameters for a fully powered trial. DESIGN: A two-armed randomised controlled, open feasibility study comparing usual care alone with usual care plus the adjunctive intervention. SETTING: Five community mental health providers in Leeds, Barnsley, Brighton and London. PARTICIPANTS: Adults aged ≥ 18 years with serious mental illness and receiving care from community mental health teams. INTERVENTIONS: A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on knowledge, motivation and behavioural intentions to adopt safer sexual behaviours. MAIN OUTCOME MEASURES: Feasibility parameters including establishing the percentage of people who were eligible, consented and were retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life. Data were collected at baseline and then at 3 months and 6 months post randomisation. RESULTS: Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial. CONCLUSIONS: Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a sexual health promotion study for people with serious mental illness. FUTURE WORK: A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15747739. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.

A team of researchers, mental health and sexual health workers, and people with lived experience of mental health problems developed an intervention to help people with serious mental health problems to increase their knowledge and understanding of sexual health, including types of contraception, using condoms safely and sexually transmitted infections, and to consider safety and assertiveness in intimate relationships. This was delivered over three sessions of 1 hour by a specifically trained mental health worker. We recruited 72 people from community mental health services to take part in a study to test the intervention and see whether or not we could collect information about their sexual behaviour using questionnaires. Initially, the numbers of people volunteering for the study were very small. We found that recruitment increased when we shifted to a more direct approach (rather than asking clinical staff to promote the study to people on their caseloads). The direct approach included talking to people who use services directly in clinics and at service user events, and by sending study information by post. We were not able to recruit the numbers that we aimed to (72/100 participants) in the timescale of the study, but the majority of the people who were recruited actively participated in the trial and were generally happy to attend follow-up appointments to complete more questionnaires. Most of those who were allocated to the intervention attended all three sessions. Overall, people found that being a participant of the study was comfortable and safe (acceptable) and we found that it was possible to undertake this type of study within mental health services. We have learnt a lot about how we could run this study on a larger scale. Such a study would allow us to see if the intervention makes a difference to sexual behaviour and increases access to sexual health services for people with serious mental illness.

Patients' experiences of assessment and detention under mental health legislation: systematic review and qualitative meta-synthesis.

BACKGROUND: Understanding patient experiences of detention under mental health legislation is crucial to efforts to reform policy and practice. AIMS: To synthesise qualitative evidence on patients' experiences of assessment and detention under mental health legislation. METHOD: Five bibliographic databases were searched, supplemented by reference list screening and citation tracking. Studies were included if they reported on patient experiences of assessment or detention under mental health legislation; reported on patients aged 18 years or older; collected data using qualitative methods; and were reported in peer-reviewed journals. Findings were analysed and synthesised using thematic synthesis. RESULTS: The review included 56 papers. Themes were generally consistent across studies and related to information and involvement in care, the environment and relationships with staff, as well as the impact of detention on feelings of self-worth and emotional state. The emotional impact of detention and views of its appropriateness varied, but a frequent theme was fear and distress during detention, including in relation to the use of force and restraint. Where staff were perceived as striving to form caring and collaborative relationships with patients despite the coercive nature of treatment, and when clear information was delivered, the negative impact of involuntary care seemed to be reduced. CONCLUSIONS: Findings suggest that involuntary in-patient care is often frightening and distressing, but certain factors were identified that can help reduce negative experiences. Coproduction models may be fruitful in developing new ways of working on in-patient wards that provide more voice to patients and staff, and physical and social environments that are more conducive to recovery. DECLARATION OF INTEREST: None.

The therapeutic needs of psychiatric in-patients with psychosis: A qualitative exploration of patient and staff perspectives.

BACKGROUND: Concerns are recurrently expressed that the therapeutic content of in-patient care is limited and lacking clear guidance. The perspectives of patients and staff regarding therapeutic priorities for psychiatric in-patient care have been little explored and compared. AIMS: The aim of this study was to examine patient and staff perspectives on the care priorities of psychiatric in-patients with psychosis. METHOD: We recruited 12 in-patients with psychosis and 12 multidisciplinary team staff. All participants undertook a semi-structured interview examining their perspectives on the therapeutic needs of people with psychosis during admission. Interviews were transcribed verbatim and thematic analysis conducted. RESULTS: Three superordinate themes arose from patient interviews: 'the importance of considering social circumstances and trauma', 'managing the intra- and interpersonal impact of psychosis' and 'lack of control and collaboration in care' and three from staff interviews: 'multidisciplinary facilitators of care', 'treating complexity and incorporating social factors' and 'restrictive practices preventing quality care provision'. Comparison of patient and staff themes identified unmet needs in addressing social marginalisation, trauma and distress, and the importance of collaborative treatment process and inclusion of spirituality. CONCLUSIONS: There are gaps between staff and patient perspectives on important priorities for in-patient care that may help explain persistent patient dissatisfaction with in-patient care. Findings suggest the need for coproduced work to develop and test interventions that address broader therapeutic priorities. DECLARATION OF INTEREST: None.

A contingency management intervention to reduce cannabis use and time to relapse in early psychosis: the CIRCLE RCT.

BACKGROUND: Cannabis is the most prevalent illicit substance among people with psychosis, and its use is associated with poorer clinical and social outcomes. However, so far, there has been limited evidence that any treatment is effective for reducing use. Contingency management (CM) is an incentive-based intervention for substance misuse that has a substantial evidence base across a range of substances and cohorts. However, to date there have been no randomised controlled trials (RCTs) of CM as a treatment for cannabis use specifically in psychosis. OBJECTIVE: To conduct a RCT investigating the clinical effectiveness and cost-effectiveness of CM in reducing cannabis use among Early Intervention in Psychosis (EIP) service users. DESIGN: The CIRCLE (Contingency Intervention for Reduction of Cannabis in Early Psychosis) trial was a rater-blinded, multicentre RCT with two arms. Participants were randomised 1 : 1 to either an CM arm, in which participants received CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only. SETTING: EIP services across the Midlands and the south-east of England. PARTICIPANTS: The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks. INTERVENTION: The CM intervention offered financial incentives (i.e. shopping vouchers) for cannabis abstinence over 12 once-weekly sessions, confirmed using urinalysis. The maximum value in vouchers that participants could receive was £240. MAIN OUTCOME MEASURES: The main outcome was time to relapse, operationalised as admission to an acute mental health service or hospital. The primary outcome was assessed at 18 months post inclusion using electronic patient records. Secondary outcomes assessed the clinical effectiveness and cost-effectiveness of the intervention, for which data were collected at 3 and 18 months. RESULTS: A total of 278 participants were randomised to the CM arm and 273 were randomised to the control arm. In total, 530 (96%) participants were followed up for the primary outcome. There was no significant difference in time to admission between trial arms by 18 months following consent (hazard ratio 1.03, 95% confidence interval 0.76 to 1.40). There were no statistically significant differences in most secondary outcomes, including cannabis use, at either follow-up assessment. There were 58 serious adverse events, comprising 52 inpatient episodes, five deaths and one arrest. LIMITATIONS: Participant retention was low at 18 months, limiting the assessment of secondary outcomes. A different CM intervention design or reward level may have been effective. CONCLUSIONS: The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use. FUTURE WORK: Cannabis use is still a significant clinical concern in this population. A pressing need remains to identify suitable treatments. A wider perspective on the social circumstances of young people with psychosis may be needed for a successful intervention to be found. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33576045. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 45. See the NIHR Journals Library website for further project information.

A large proportion of people with psychosis use cannabis, despite the negative impact that it has on their recovery. So far, a clearly effective way of helping young people in the early stages of psychosis to cut down their cannabis use has not been found. The CIRCLE trial investigated if an approach known as contingency management (CM) would be beneficial for this group. This approach involves offering voucher rewards for not using cannabis. It has been effective in addressing drug use problems in general, but there is not much evidence about its effects on cannabis use in those with psychosis. A total of 551 service users with psychosis who used cannabis agreed to enter the trial. Half of the sample group was chosen by a chance method to receive CM. The other half formed a comparison group. The CM group received shopping vouchers if urine samples showed that they had not used cannabis for the previous week, measured over 12 weekly sessions. Participants could obtain £240-worth of vouchers if they did not use cannabis during the treatment period. The participants in both groups were also offered a six-session psychoeducation programme about the pros and cons of cannabis use and ways to reduce use of it. The main comparison in the trial was the average length of time in each group before a relapse of psychosis occurred, which was recorded for each participant over 18 months after they joined the trial. The results found no difference between the two trial groups in this measure. Furthermore, there were no differences found between the groups in terms of the levels of cannabis use, clinical symptoms, or engagement with work or education. However, a cost-effectiveness analysis found an 85% chance of CM being more effective than the treatment-as-usual psychoeducation package, which appears to be because of the lower use of inpatient services by those receiving CM. However, it is difficult to understand why this was, because there was no drop in cannabis use. The results suggest that CM is unlikely to be clinically effective and that alternative treatments are still needed.

Clinical and cost-effectiveness of contingency management for cannabis use in early psychosis: the CIRCLE randomised clinical trial.

BACKGROUND: Cannabis is the most commonly used illicit substance amongst people with psychosis. Continued cannabis use following the onset of psychosis is associated with poorer functional and clinical outcomes. However, finding effective ways of intervening has been very challenging. We examined the clinical and cost-effectiveness of adjunctive contingency management (CM), which involves incentives for abstinence from cannabis use, in people with a recent diagnosis of psychosis. METHODS: CIRCLE was a pragmatic multi-centre randomised controlled trial. Participants were recruited via Early Intervention in Psychosis (EIP) services across the Midlands and South East of England. They had had at least one episode of clinically diagnosed psychosis (affective or non-affective); were aged 18 to 36; reported cannabis use in at least 12 out of the previous 24 weeks; and were not currently receiving treatment for cannabis misuse, or subject to a legal requirement for cannabis testing. Participants were randomised via a secure web-based service 1:1 to either an experimental arm, involving 12 weeks of CM plus a six-session psychoeducation package, or a control arm receiving the psychoeducation package only. The total potential voucher reward in the CM intervention was £240. The primary outcome was time to acute psychiatric care, operationalised as admission to an acute mental health service (including community alternatives to admission). Primary outcome data were collected from patient records at 18 months post-consent by assessors masked to allocation. The trial was registered with the ISRCTN registry, number ISRCTN33576045. RESULTS: Five hundred fifty-one participants were recruited between June 2012 and April 2016. Primary outcome data were obtained for 272 (98%) in the CM (experimental) group and 259 (95%) in the control group. There was no statistically significant difference in time to acute psychiatric care (the primary outcome) (HR 1.03, 95% CI 0.76, 1.40) between groups. By 18 months, 90 (33%) of participants in the CM group, and 85 (30%) of the control groups had been admitted at least once to an acute psychiatric service. Amongst those who had experienced an acute psychiatric admission, the median time to admission was 196 days (IQR 82, 364) in the CM group and 245 days (IQR 99, 382) in the control group. Cost-effectiveness analyses suggest that there is an 81% likelihood that the intervention was cost-effective, mainly resulting from higher mean inpatient costs for the control group compared with the CM group; however, the cost difference between groups was not statistically significant. There were 58 adverse events, 27 in the CM group and 31 in the control group. CONCLUSIONS: Overall, these results suggest that CM is not an effective intervention for improving the time to acute psychiatric admission or reducing cannabis use in psychosis, at least at the level of voucher reward offered.