CLEAR - clozapine in early psychosis: study protocol for a multi-centre, randomised controlled trial of clozapine vs other antipsychotics for young people with treatment resistant schizophrenia in real world settings.

BACKGROUND: Clozapine is an antipsychotic drug with unique efficacy, and it is the only recommended treatment for treatment-resistant schizophrenia (TRS: failure to respond to at least two different antipsychotics). However, clozapine is also associated with a range of adverse effects which restrict its use, including blood dyscrasias, for which haematological monitoring is required. As treatment resistance is recognised earlier in the illness, the question of whether clozapine should be prescribed in children and young people is increasingly important. However, most research to date has been in older, chronic patients, and evidence regarding the efficacy and safety of clozapine in people under age 25 is lacking. The CLEAR (CLozapine in EARly psychosis) trial will assess whether clozapine is more effective than treatment as usual (TAU), at the level of clinical symptoms, patient rated outcomes, quality of life and cost-effectiveness in people below 25 years of age. Additionally, a nested biomarker study will investigate the mechanisms of action of clozapine compared to TAU. METHODS AND DESIGN: This is the protocol of a multi-centre, open label, blind-rated, randomised controlled effectiveness trial of clozapine vs TAU (any other oral antipsychotic monotherapy licenced in the British National Formulary) for 12 weeks in 260 children and young people with TRS (12-24 years old). AIM AND OBJECTIVES: The primary outcome is the change in blind-rated Positive and Negative Syndrome Scale scores at 12 weeks from baseline. Secondary outcomes include blind-rated Clinical Global Impression, patient-rated outcomes, quality of life, adverse effects, and treatment adherence. Patients will be followed up for 12 months and will be invited to give consent for longer term follow-up using clinical records and potential re-contact for further research. For mechanism of action, change in brain magnetic resonance imaging (MRI) biomarkers and peripheral inflammatory markers will be measured over 12 weeks. DISCUSSION: The CLEAR trial will contribute knowledge on clozapine effectiveness, safety and cost-effectiveness compared to standard antipsychotics in young people with TRS, and the results may guide future clinical treatment recommendation for early psychosis. TRIAL REGISTRATION: ISRCTN Number: 37176025, IRAS Number: 1004947. TRIAL STATUS: In set-up. Protocol version 4.0 01/08/23. Current up to date protocol available here: https://fundingawards.nihr.ac.uk/award/NIHR131175# /.

The relationship between deinstitutionalization and quality of care in longer-term psychiatric and social care facilities in Europe: A cross-sectional study.

BACKGROUND: The process of deinstitutionalization (community-based care) has been shown to be associated with better quality of life for those with longer-term mental health problems compared to long stay hospitals. This project aimed to investigate the relationship between national progress towards deinstitutionalization and (1) quality of longer-term mental health care (2) service users' ratings of that care in nine European countries. METHODS: Quality of care was assessed in 193 longer-term hospital- and community-based facilities in Bulgaria, Germany, Greece, Italy, the Netherlands, Poland, Portugal, Spain and the UK. Data on users' ratings of care were collected from 1579 users of these services. Country level variables were compiled from publicly available data. Multilevel models were fit to assess associations with quality of care and service user experiences of care. RESULTS: Significant positive associations were found between deinstitutionalization and (1) five of seven quality of care domains; and (2) service user autonomy. A 10% increase in expenditure was associated with projected clinically important improvements in quality of care. CONCLUSIONS: Greater deinstitutionalization of mental health mental health services is associated with higher quality of care and better service user autonomy.

Contemporary mental health rehabilitation.

In the United Kingdom, contemporary mental health rehabilitation services evolved during the period of deinstitutionalisation. They focus on people with complex psychosis, a "low volume, high needs" group which is at risk of social exclusion. Without these specialist services, this group is at risk of becoming stuck in a hospital or in other facilities that do not enable them to achieve their optimal level of autonomy. When a "whole system" of rehabilitative care is provided, including specialist inpatient facilities and supported accommodation, the majority are able to progress in their recovery and live successfully in the community. Rehabilitation is a complex intervention; current and further research is needed to identify the specific aspects of treatment and support it delivers that are most effective in enabling recovery and social inclusion for those with the most complex and long-term mental health needs.

The nature and correlates of paid and unpaid work among service users of London Community Mental Health Teams.

Aims. Little is known about how the rates and characteristics of mental health service users in unpaid work, training and study compare with those in paid employment. Methods. From staff report and patient records, 1353 mental health service users of seven Community Mental Health Teams in two London boroughs were categorized as in paid work, unpaid vocational activity or no vocational activity. Types of work were described using Standard Occupational Classifications. The characteristics of each group were reported and associations with vocational status were explored. Results. Of the sample, 5.5% were in paid work and 12.7% were in unpaid vocational activity, (including 5.3% in voluntary work and 8.1% in study or training). People in paid work were engaged in a broader range of occupations than those in voluntary work and most in paid work (58.5%) worked part-time. Younger age and high educational attainment characterized both groups. Having sustained previous employment was most strongly associated with being in paid work. Conclusions. Rates of vocational activity were very low. Results did not suggest a clear clinical distinction between those in paid and unpaid activity. The motivations for and functions of unpaid work need further research.

Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

OBJECTIVE: To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN: A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING: Study participants were recruited from secondary care mental health and social services in four UK centres. PARTICIPANTS: Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. INTERVENTIONS: Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. MAIN OUTCOME MEASURES: Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months after randomisation. RESULTS: Four hundred and seventeen people were recruited, of whom 355 (85%) were followed up at 2 years. Eighty-six (61%) of those randomised to art therapy and 73 (52%) of those randomised to activity groups attended at least one group. No differences in primary outcomes were found between the three study arms. The adjusted mean difference between art therapy and standard care at 24 months was -0.9 [95% confidence interval (CI) -3.8 to 2.1] on the GAF Scale and 0.7 (95% CI -3.1 to 4.6) on the PANSS Scale. Differences in secondary outcomes were not found, except that those referred to an activity group had fewer positive symptoms of schizophrenia at 24 months than those randomised to art therapy. Secondary analysis indicated that attendance at art therapy groups was not associated with improvements in global functioning or mental health. Although the total cost of the art therapy group was lower than the cost of the two comparison groups, referral to group art therapy did not appear to provide a cost-effective use of resources. CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this randomised trial does not appear to improve global functioning or mental health of patients or provide a more cost-effective use of resources than standard care alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 46150447. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 8. See the HTA programme website for further project information.

A comparison of the implementation of assertive community treatment in Melbourne, Australia and London, England.

AIMS: The efficacy of Assertive Community Treatment (ACT) is well established in the USA, and to a lesser extent in Australia, whereas UK studies suggest little advantage for ACT over usual care. Implementation of ACT varies and these differences may explain variability in reported efficacy. We aimed to investigate differences in ACT implementation between Melbourne, Australia and London, UK. METHODS: In a cross-sectional survey, we investigated team organisation, staff and client characteristics from four Melbourne ACT teams using almost identical methods to the Pan London Assertive Outreach studies of 24 ACT teams. RESULTS: Client characteristics, staff satisfaction and burnout were very similar. Three of four Melbourne teams made over 70% of client contacts 'in vivo' compared to only one-third of comparable London teams, although all teams were rated as 'ACT-like'. Melbourne teams scored more highly on team approach. Three quarters of clients were admitted in the preceding 2 years but Melbourne clients had shorter stays. CONCLUSIONS: Differences in the implementation of 'active components' of home treatment models that have been associated with better client outcomes (home visiting, team approach) may explain international differences in ACT efficacy. Existing fidelity measures may not adequately weight these important elements of the model.

Effectiveness and cost-effectiveness of admissions to women's crisis houses compared with traditional psychiatric wards: pilot patient-preference randomised controlled trial.

BACKGROUND: Women's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards. AIMS: To examine the effectiveness and cost-effectiveness of women's crisis houses by first examining the feasibility of a pilot patient-preference randomised controlled trial (PP-RCT) design (ISRCTN20804014). METHOD: We used a PP-RCT study design to investigate women presenting in crisis needing informal admission. The four study arms were the patient preference arms of women's crisis house or hospital admission, and randomised arms of women's crisis house or hospital admission. RESULTS: Forty-one women entered the randomised arms of the trial (crisis house n = 19, wards n = 22) and 61 entered the patient-preference arms (crisis house n = 37, ward n = 24). There was no significant difference in outcomes (symptoms, functioning, perceived coercion, stigma, unmet needs or quality of life) or costs for any of the groups (randomised or preference arms), but women who obtained their preferred intervention were more satisfied with treatment. CONCLUSIONS: Although the sample sizes were too small to allow definite conclusions, the results suggest that when services are able to provide interventions preferred by patients, those patients are more likely to be satisfied with treatment. This pilot study provides some evidence that women's crisis houses are as effective as traditional psychiatric wards, and may be more cost-effective.

Prospective controlled study of psychiatric out-patient non-attendance. Characteristics and outcome.

BACKGROUND: Psychiatric clinics have high non-attendance rates and failure to attend may be a sign of deteriorating mental health. AIMS: To investigate why psychiatric out-patients fail to attend, and the outcome of attenders and non-attenders. METHOD: Prospective cohort study of randomly selected attenders and non-attenders at general adult psychiatric out-patient clinics. Subjects were interviewed at recruitment and severity of mental disorder and degree of social adjustment were measured. Six and 12 months later their engagement with the clinic and any psychiatric admissions were ascertained. RESULTS: Of the 365 patients included in the study, 30 were untraceable and 224 consented to participate. Follow-up patients were more psychiatrically unwell than new patients. For follow-up patients, non-attenders had lower social functioning and more severe mental disorder than those who attended. At 12-month follow-up patients who missed their appointment were more likely to have been admitted than those who attended. CONCLUSIONS: Those who miss psychiatric follow-up out-patient appointments are more unwell and more poorly socially functioning than those who attend. They have a greater chance of drop-out from clinic contact and subsequent admission.

Non-attendance at psychiatric outpatient clinics: communication and implications for primary care.

BACKGROUND: What should happen when an outpatient fails to attend a psychiatric clinic? Guidelines from the General Medical Services Committee suggest that general practitioners (GPs) have no further responsibility of care for a patient once a referral to a psychiatrist has been made. This raises questions about the formulation of effective management plans for those patients with whom psychiatric services find it difficult to engage due to non-compliance with assessment and follow-up. AIMS: To investigate communication between GPs, patients, and psychiatrists at referral and following attendance or non-attendance at outpatient appointments. METHOD: A prospective study of a random sample of attenders and non-attenders at psychiatric outpatient clinics. Patients and GPs were interviewed to obtain data about the referral process. GPs' views on communication from psychiatrists and the appropriate course of action following clinic non-attendance were investigated. The quality of referral and clinic letters for attenders and non-attenders was compared. RESULTS: There was no difference in the quality of referral letter for attenders and non-attenders. Psychiatrists were less likely to write to GPs about follow-up patients' appointments than new patients' appointments; communication was least likely when a follow-up patient missed their appointment. GPs considered follow-up non-attenders were more likely to need a further appointment than new patient non-attenders, but did not identify a role for themselves in engaging with follow-up non-attenders. CONCLUSION: Communication between GPs and psychiatrists about new patients seems adequate. However, there are important deficits in communication from psychiatrists to GPs about follow-up patients, especially non-attenders who are often more severely ill and difficult to engage. An effective response for this group is likely to need cooperative health and social service action rather than rigid guidelines concerning clinical responsibility.