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.

Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial.

BACKGROUND: Current NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The 'PARTNERS2' complex intervention is designed to support individuals with psychosis in a primary care setting. AIM: The trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention. DESIGN & SETTING: This is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with usual care, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth, and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care ('intervention'); or (b) standard care only ('control'). METHOD: PARTNERS2 is a flexible, general practice-based, person-centred, coaching-based intervention aimed at addressing mental health, physical health, and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life (QOL). Secondary outcomes include: mental wellbeing, time use, recovery, and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action, and look for unintended consequences. An economic evaluation will estimate its cost-effectiveness. Intervention delivery and follow-up have been modified during the COVID-19 pandemic. CONCLUSION: The overarching aim is to establish the clinical and cost-effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychoses.

After the storm, Solar comes out: A new service model for children and adolescent mental health.

AIM: Existing children and adolescent mental health services in the United Kingdom have many gaps, such as reduced access to community-based services, and a lack of early intervention, prevention, and 24/7 crisis care. These gaps prevent timely access to appropriate levels of care, decrease children and young people's engagement with providers, and lead to increased pressures on urgent and emergency care. In this paper, we outline a newly created 0-19 model and its crisis service, which have been transformed into a fully integrated, "joint partnership" service, in line with the recommendations from the recent UK policies that aim to meet the aforementioned challenges. METHOD: The "Solar" service is described as a case study of a 0-19 service model. We cover the national and local contexts of the service, in addition to its rationale, aims, organizational structure, strengths and limitations. RESULTS: The presented model is a fully integrated and innovative example of a service model that operates without tiers, and helps to create an inclusive, compassionate, stigma-free and youth-friendly environment. Additionally, the model aims to prioritize recovery, early intervention, prevention and the development of resilience. CONCLUSION: The 0-19 model is a result of the recent transformation of children and youth mental health services in the United Kingdom. The ongoing evaluation of the 0-19 model and its crisis component will investigate the model's effectiveness, accessibility and acceptability, as well as understanding the potential of the model to contribute towards solving numerous gaps in the existing mental health service provision within the United Kingdom.

Co-designing a virtual world with young people to deliver social cognition therapy in early psychosis.

AIMS: Co-design implies genuine partnership in the generation of knowledge between service users and researchers. Service user involvement in research has been encouraged in government policy, but it is rarely achieved, especially at trial initial stages. Co-designed with service users, we adapted existing manualised social cognition intervention for people with a first episode of psychosis to a virtual world environment. METHODS: We invited a group of young people who have used mental health services to co-design a virtual environment to deliver an accessible social cognition intervention to a hard to engage service user group. We used an iterative process with young service users and the design team that included developing initial ideas, creating a prototype and testing the virtual world. RESULTS: Twenty young service users of local mental healthcare services provided feedback on the design and delivery of the intervention. Reflecting the demographic of the sample, young people felt the virtual environment should be familiar, urban spaces, akin to therapy rooms or classrooms they have used in real-life situations rather than non-traditional therapy spaces that were initially proposed. CONCLUSION: The co-design process led to the development of a specific design, approach and protocol to be tested in a proof-of-concept trial. Young service users were integral to an agile and iterative design. Technological innovations should be routinely co-designed and co-produced if they are to realise their potential to deliver acceptable and affordable mental health interventions.

The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial.

BACKGROUND: Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. METHODS: This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. DISCUSSION: It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience. TRIAL REGISTRATION: ISRCTN, ISRCTN14678860 , Registered on 6 June 2016.

Cost-effectiveness of early intervention services for psychosis and fidelity to national policy implementation guidance.

AIM: Early intervention services (EIS) for psychosis are being implemented, internationally. It is important to learn from established examples and define the components and intensity of services that provide good value for money. This study aims to assess the cost-effectiveness of EIS according to how closely they adhered to the recommendations of the English Department of Health 2001 Policy Implementation Guide (PIG). METHODS: EIS from the National Eden Study were assessed using a measure of fidelity to the PIG that rated the presence or absence of 64 recommended items relating to team structure and practice. EIS were then classified into three groups: those with fidelity of 75-80%, 81-90% and 91-95%. Patient-level resource use and outcomes were measured 1 year following inception into the service; costs were calculated and combined with quality-adjusted life years (QALYs) gained. RESULTS: At a threshold of £20 000 per QALY, the 81-90% fidelity group had a 56.3% likelihood of being the most cost-effective option followed by 75-80% fidelity at 35.8% and 91-95% fidelity group (7.9%). CONCLUSIONS: The results from England suggest that striving to maximize fidelity may not be warranted, but that dropping below a certain level of fidelity may result in inefficient use of resources.

Informed, advance refusals of treatment by people with severe mental illness in a randomised controlled trial of joint crisis plans: demand, content and correlates.

BACKGROUND: In the UK, crisis planning for mental health care should acknowledge the right to make an informed advance treatment refusal under the Mental Capacity Act 2005. Our aims were to estimate the demand for such treatment refusals within a sample of service users who had had a recent hospital admission for psychosis or bipolar disorder, and to examine the relationship between refusals, and service user characteristics. METHODS: To identify refusals we conducted content analysis of Joint Crisis Plans, which are plans formulated by service users and their clinical team with involvement from an external facilitator, and routine care plans in sub-samples from a multi-centre randomised controlled trial of Joint Crisis Plans (plus routine mental health care) versus routine care alone (CRIMSON) in England. Factors hypothesised to be associated with refusals were identified using the trial data collected through baseline interviews of service users and clinicians and collection of routine clinical data. RESULTS: Ninety-nine of 221 (45%) of the Joint Crisis Plans contained a treatment refusal compared to 10 of 424 (2.4%) baseline routine care plans. No Joint Crisis Plans recorded disagreement with refusals on the part of clinicians. Among those with completed Joint Crisis Plans, adjusted analyses indicated a significant association between treatment refusals and perceived coercion at baseline (odds ratio = 1.21, 95% CI 1.02-1.43), but not with baseline working alliance or a past history of involuntary admission. CONCLUSIONS: We demonstrated significant demand for written treatment refusals in line with the Mental Capacity Act 2005, which had not previously been elicited by the process of treatment planning. Future treatment/crisis plans should incorporate the opportunity for service users to record a treatment refusal during the drafting of such plans. TRIAL REGISTRATION: ISRCTN11501328 Registered 13th March 2008.

Transitioning care-leavers with mental health needs: 'they set you up to fail!'

BACKGROUND: Children in the UK care system often face multiple disadvantages in terms of health, education and future employment. This is especially true of mental health where they present with greater mental health needs than other children. Although transition from care - the process of leaving the local authority as a child-in-care to independence - is a key juncture for young people, it is often experienced negatively with inconsistency in care and exacerbation of existing mental illness. Those receiving support from child and adolescent mental health services (CAMHS), often experience an additional, concurrent transfer to adult services (AMHS), which are guided by different service models which can create a care gap between services. METHOD: This qualitative study explored care-leavers' experiences of mental illness, and transition in social care and mental health services. Twelve care-leavers with mental health needs were interviewed and data analysed using framework analysis. RESULTS: Sixteen individual themes were grouped into four superordinate themes: overarching attitudes towards the care journey, experience of social care, experience of mental health services and recommendations. CONCLUSIONS: Existing social care and mental health teams can improve the care of care-leavers navigating multiple personal, practical and service transitions. Recommendations include effective Pathway Planning, multiagency coordination, and stating who is responsible for mental health care and its coordination. Participants asked that youth mental health services span the social care transition; and provide continuity of mental health provision when care-leavers are at risk of feeling abandoned and isolated, suffering deteriorating mental health and struggling to establish new relationships with professionals. Young people say that the key to successful transition and achieving independence is maintaining trust and support from services.

The course of negative symptom in first episode psychosis and the relationship with social recovery.

AIMS: To investigate trajectories of negative symptoms during the first 12months of treatment for first episode psychosis (FEP), their predictors and relationship to social recovery. METHOD: 1006 participants were followed up for 12months following acceptance into Early Intervention in Psychosis services. Negative symptom trajectories were modelled using latent class growth analysis (LCGA) and predictors of trajectories examined using multinomial regression. Social recovery trajectories - also modelled using LCGA - of members of each negative symptom trajectory were ascertained and the relationship between negative symptom and social recovery trajectories examined. RESULTS: Four negative symptom trajectories were identified: Minimal Decreasing (63.9%), Mild Stable (13.5%), High Decreasing (17.1%) and High Stable (5.4%). Male gender and family history of non-affective psychosis predicted stably high negative symptoms. Poor premorbid adolescent adjustment, family history of non-affective psychosis and baseline depression predicted initially high but decreasing negative symptoms. Members of the Mild Stable, High Stable and High Decreasing classes were more likely to experience stably low functioning than the Minimal Decreasing class. CONCLUSIONS: Distinct negative symptom trajectories are evident in FEP. Only a small subgroup present with persistently high levels of negative symptoms. A substantial proportion of FEP patients with elevated negative symptoms at baseline will achieve remission of these symptoms within 12months. However, elevated negative symptoms at baseline, whether or not they remit, are associated with poor social recovery, suggesting targeted interventions for service users with elevated baseline negative symptoms may help improve functional outcomes.

A pilot study to assess the feasibility and impact of a brief motivational intervention on problem drug and alcohol use in adult mental health inpatient units: study protocol for a randomized controlled trial.

BACKGROUND: Substance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes. Up to 44% of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems. However, this is not routinely addressed as part of their treatment plan. A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use. This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention. METHODS/DESIGN: This randomized controlled trial will use concealed randomization; blind, independent assessment of outcome at 3 months; characterization of refusers and dropouts; and be analyzed according to the intention-to-treat principle. After baseline assessments, eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual, or Treatment as Usual alone. Eligible participants will be those who are new admissions; >18 years; ICD-10 diagnosis of -schizophrenia or related disorder, bipolar affective disorder, recurrent depressive disorder, and DSM-IV diagnosis of substance abuse or dependence over the last 3 months. The primary outcome is engagement in treatment for substance misuse, and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis. Qualitative interviews with staff and participants will assess the acceptability of the intervention. DISCUSSION: This pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible, cost-effective, and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care. TRIAL REGISTRATION: ISRCTN43548483 Date of ISRCTN assignation: 4/17/2014.

Protocol for a systematic review and meta-analysis of cognitive-behavioural therapy for social anxiety disorder in psychosis.

BACKGROUND: Social anxiety is among the most prevalent and debilitating affective disturbances manifest in people with psychosis. It is usually accompanied by high levels of depression and leads to significant social disability, lower quality of life and poorer prognosis as it raises the possibility of an early relapse. Despite its elevated prevalence and severity in psychosis, social anxiety remains under-recognized and under-treated. Cognitive-behavioural therapy is recommended for the treatment of people with psychosis. However, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms, and not for co-morbid affective disturbances such as social anxiety. There is lack of evidence on the clinical effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in psychosis. METHODS/DESIGN: Electronic databases will be systematically searched for randomised controlled trials and quasi-experimental studies investigating the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. Grey literature will also be searched by screening trial registers. Only studies published in English will be included in the review. Date restrictions will not be applied. Eligible studies will have as the primary outcome social anxiety (continuous data) measured using any psychometrically validated scale both self-reported and clinician administered. Secondary outcomes will include general anxiety symptoms, distress, depression, positive and negative symptoms of schizophrenia, and quality of life measured using any psychometrically validated scale, both self-reported and clinician administered, and the cost of cognitive-behaviour therapy (CBT) intervention (with another treatment or treatment-as-usual). CONCLUSIONS: This review will provide an evidence synthesis of the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. The review will identify the specific intervention components associated with effectiveness which will facilitate the translation of the existing evidence to the development of new, targeted interventions optimising these components. In doing so, this review will provide recommendations for the treatment of social anxiety and associated distress in psychosis and will further inform the development of future interventions in this area. TRIAL REGISTRATION: PROSPERO registration numberCRD42014009052.

The UK national evaluation of the development and impact of Early Intervention Services (the National EDEN studies): study rationale, design and baseline characteristics.

AIMS: National EDEN aims to evaluate the implementation and impact on key outcomes of somewhat differently configured Early Intervention Services (EIS) across sites in England and to develop a model of variance in patient outcomes that includes key variables of duration of untreated psychosis (DUP), fidelity to the EIS model and service engagement. The cohort is being followed up for two further years as patients are discharged, to observe the stability of change and the impact of the discharge settings. METHODS: A longitudinal cohort study of patients with a first episode of a psychosis, managed by EIS in six services across England. Patients are followed up 12 months after inception, then up to 2 years following discharge. Measures of DUP, psychosis, social functioning and relapse were taken. User and carer experience of EIS were monitored over time; as was the fidelity of each EIS to national guidelines. Service use is costed for a health economic evaluation. RESULTS: 1027 people consented to the study of which 75% were successfully followed up at 12 months, with almost 100% data on treatment, relapse and recovery and service use. CONCLUSIONS: National EDEN is the largest cohort study of young people with psychosis receiving care under EIS. It will be able definitively to indicate whether this major investment in the United Kingdom in EI is achieving meaningful change for its users in practice and provide indications concerning who does well under this approach and who does not, and the long-term stability of any improvements.

Randomised controlled trial of joint crisis plans to reduce compulsory treatment for people with psychosis: economic outcomes.

BACKGROUND: Compulsory admission to psychiatric hospitals may be distressing, disruptive to patients and families, and associated with considerable cost to the health service. Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services. METHODS: Economic evaluation within a multi-centre randomised controlled trial comparing Joint Crisis Plans (JCP) plus treatment as usual (TAU) to TAU alone for patients aged over 16, with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register. JCPs, containing the patient's treatment preferences for any future psychiatric emergency, are a form of crisis intervention that aim to mitigate the negative consequences of relapse, including hospital admission and use of coercion. Data were collected at baseline and 18-months after randomisation. The primary outcome was admission to hospital under the Mental Health Act. The economic evaluation took a service perspective (health, social care and criminal justice services) and a societal perspective (additionally including criminal activity and productivity losses). FINDINGS: The addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up. From the service cost perspective, however, evidence suggests a higher probability (80%) of JCPs being the more cost-effective option. Exploration by ethnic group highlights distinct patterns of costs and effects. Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups, there is at least a 90% probability of the JCP intervention being the more cost-effective option in the Black ethnic group. INTERPRETATION: The results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11501328.

Mental health services for young people: matching the service to the need.

It is now known that the onset of severe and recurring mental health problems begins for the most part before the age of 25: this provides a clear focus for preventive strategies and public mental health that are a feature of many health policy frameworks. The present distinction between child and adolescent mental health services and adult services at 16 or 18 does not fit easily with these data and the now well-documented problems of transition suggest that a fundamental review of services for young people is overdue. This supplement provides an overview of the epidemiological, conceptual and service structures for young people with emergent and existing mental health problems, and asks the question, 'How should we design services for young people to promote prevention and service engagement, and to improve outcomes?'

Designing youth mental health services for the 21st century: examples from Australia, Ireland and the UK.

Despite the evidence showing that young people aged 12-25 years have the highest incidence and prevalence of mental illness across the lifespan, and bear a disproportionate share of the burden of disease associated with mental disorder, their access to mental health services is the poorest of all age groups. A major factor contributing to this poor access is the current design of our mental healthcare system, which is manifestly inadequate for the unique developmental and cultural needs of our young people. If we are to reduce the impact of mental disorder on this most vulnerable population group, transformational change and service redesign is necessary. Here, we present three recent and rapidly evolving service structures from Australia, Ireland and the UK that have each worked within their respective healthcare contexts to reorient existing services to provide youth-specific, evidence-based mental healthcare that is both accessible and acceptable to young people.

A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations.

BACKGROUND: Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations. METHODS/DESIGN: This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations. DISCUSSION: Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue. TRIAL REGISTRATION: ISRCTN: ISRCTN62304114.

CRIMSON [CRisis plan IMpact: Subjective and Objective coercion and eNgagement] protocol: a randomised controlled trial of joint crisis plans to reduce compulsory treatment of people with psychosis.

BACKGROUND: The use of compulsory treatment under the Mental Health Act (MHA) has continued to rise in the UK and in other countries. The Joint Crisis Plan (JCP) is a statement of service users' wishes for treatment in the event of a future mental health crisis. It is developed with the clinical team and an independent facilitator. A recent pilot RCT showed a reduction in the use of the MHA amongst service users with a JCP. The JCP is the only intervention that has been shown to reduce compulsory treatment in this way. The CRIMSON trial aims to determine if JCPs, compared with treatment as usual, are effective in reducing the use of the MHA in a range of treatment settings across the UK. METHODS/DESIGN: This is a 3 centre, individual-level, single-blind, randomised controlled trial of the JCP compared with treatment as usual for people with a history of relapsing psychotic illness in Birmingham, London and Lancashire/Manchester. 540 service users will be recruited across the three sites. Eligible service users will be adults with a diagnosis of a psychotic disorder (including bipolar disorder), treated in the community under the Care Programme Approach with at least one admission to a psychiatric inpatient ward in the previous two years. Current inpatients and those subject to a community treatment order will be excluded to avoid any potential perceived pressure to participate. Research assessments will be conducted at baseline and 18 months. Following the baseline assessment, eligible service users will be randomly allocated to either develop a Joint Crisis Plan or continue with treatment as usual. Outcome will be assessed at 18 months with assessors blind to treatment allocation. The primary outcome is the proportion of service users treated or otherwise detained under an order of the Mental Health Act (MHA) during the follow-up period, compared across randomisation groups. Secondary outcomes include overall costs, service user engagement, perceived coercion and therapeutic relationships. Sub-analyses will explore the effectiveness of the JCP in reducing use of the MHA specifically for Black Caribbean and Black African service users (combined). Qualitative investigations with staff and service users will explore the acceptability of the JCPs. DISCUSSION: JCPs offer a potential solution to the rise of compulsory treatment for individuals with psychotic disorders and, if shown to be effective in this trial, they are likely to be of interest to mental health service providers worldwide. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11501328.

Disability in people clinically at high risk of psychosis.

BACKGROUND: Decline in social functioning occurs in individuals who later develop psychosis. AIMS: To investigate whether baseline differences in disability are present in those who do and those who do not make a transition to psychosis in a group clinically at high risk and whether disability is a risk factor for transition. METHOD: Prospective multicentre, naturalistic field study with an 18-month follow-up period on 245 help-seeking individuals clinically at high risk. Disability was assessed with the Disability Assessment Schedule of the World Health Organization (WHODAS-II). RESULTS: At baseline, the transition group displayed significantly greater difficulties in making new friends (z = -3.40, P = 0.001), maintaining a friendship (z =-3.00, P = 0.003), dealing with people they do not know (z =-2.28, P = 0.023) and joining community activities (z =-2.0, P = 0.05) compared with the non-transition group. In Cox regression, difficulties in getting along with people significantly contributed to the prediction of transition to psychosis in our sample (ß = 0.569, s.e. = 0.184, Wald = 9.548, P = 0.002, hazard ratio (HR) = 1.767, 95% CI 1.238-2.550). CONCLUSIONS: Certain domains of social disability might contribute to the prediction of psychosis in a sample clinically at high risk.