A brief CBT intervention for depersonalisation-derealisation disorder in psychosis: Results from a feasibility randomised controlled trial.

BACKGROUND AND OBJECTIVES: Depersonalisation/derealisation symptoms are prevalent in psychosis patients, are associated with increased impairment, and may maintain psychosis symptoms. We aimed to establish the feasibility and acceptability of a brief, six session therapy protocol adapted from a Cognitive-Behavioural model of Depersonalisation-Derealisation Disorder (DDD) in participants with psychotic symptoms. METHODS: A single-blind, randomised controlled trial was conducted with a treatment-as-usual control condition. Feasibility and acceptability estimates included rates of referral, acceptance, eligibility, consent, satisfaction and improved skills/knowledge to manage depersonalisation. RESULTS: Twenty-one individuals were recruited to the trial. Results suggest that the intervention was feasible and acceptable to participants and there is some signal of effect on clinical outcomes. LIMITATIONS: There were some challenges in recruitment. Recruitment feasibility estimates from the research register used may not be informative for future trials recruiting directly from teams. CONCLUSIONS: Overall, the results suggest that further investigations would be of interest and recommendations for this are made.

The clinical and functional outcomes of a large naturalistic cohort of young people accessing national early psychosis services.

AIMS: Services for individuals with a first episode of psychosis or at ultra-high risk of psychosis have become a treatment model of choice in mental health care. The longitudinal changes in clinical and functional outcomes as a result of real-world treatment remain under-reported. METHODS: We analysed data from first episode of psychosis and ultra-high risk services delivered across Australian primary youth mental health care services known as headspace between 19 June 2017 and 30 September 2019. Outcome measures were completed and entered into a minimum dataset every 90 days a participant was receiving treatment and included psychiatric symptomatology (Brief Psychiatric Rating Scale and psychological distress, K10) and psychosocial functioning (Social and Occupational Functioning Assessment Scale and My Life Tracker). Linear mixed-effects models were used to evaluate changes in outcome over time. RESULTS: Outcome data from a total of 1252 young people were evaluated (643 first episode of psychosis, 609 ultra-high risk). Of those who entered ultra-high risk services, 11.8% transitioned to first episode of psychosis services. Overall, substantial improvement in clinical (Brief Psychiatric Rating Scale, K10) and functional (Social and Occupational Functioning Assessment Scale, My Life Tracker) outcomes were seen across groups and outcomes. Ultra-high risk patients showed a greater reduction in distress symptoms, while first episode of psychosis patients experienced a greater reduction in positive psychosis symptoms. Although clinical outcomes showed a plateau effect after approximately 3 months of care, improvement in functional outcomes (Social and Occupational Functioning Assessment Scale, My Life Tracker) continued later in treatment. CONCLUSION: These findings support the use of real-time, real-world and low-cost administrative data to rigorously evaluate symptomatic and functional outcomes in early psychosis treatment settings. Findings that functional outcomes improve past the remittance of clinical outcomes also support the functional recovery focus of early psychosis services and remaining high levels of distress suggest the need for ultra-high risk services to extend beyond 6 months of care.

The utility of a fidelity measure to monitor implementation of new early psychosis services across Australia.

AIM: Early psychosis delivery models have proliferated worldwide, but there is limited research into establishing model fidelity. In this context, this article aims to describe the development and implementation of a fidelity tool in a national network of early psychosis services across Australia-the headspace Early Psychosis program. METHODS: Following a detailed consultation process, and based on the Australian Early Psychosis model, an 80-item Early Psychosis Prevention and Intervention Centre Model Integrity Tool (EMIT) was developed along with predefined thresholds for fidelity. The tool was used to assess adherence to the model in six clusters of service sites across Australia. Ratings on the EMIT were informed by interviews with site staff and young people receiving the service, routinely collected data and site policies and procedures. RESULTS: All six clusters of headspace Early Psychosis programs participated in five fidelity assessments across a period of two and a half years. In the initial two visits, the average fidelity score was in the 'low' fidelity range (i.e., <75%). By the fifth fidelity visit, the network average improved to 92.35%, reflecting 'superior' fidelity. CONCLUSIONS: Results of the longitudinal fidelity assessments indicate the successful implementation of the Australian Early Psychosis model across the headspace Early Psychosis program. Utilisation of ongoing fidelity assessments has proved an effective method to improve and maintain adherence to the model.

The development and validation of the Brief Experience of Caregiving Inventory (BECI).

BACKGROUND: The social network supporting an individual with psychosis may be adversely affected by the experience of caregiving. The Experience of Caregiving Inventory (ECI) is 66 item self-report measure of the impact of caregiving for carers of people diagnosed with psychotic disorders. This study aimed to create a brief version of the ECI, and evaluate its reliability and validity (n = 626). METHODS: The validation process was conducted through a Multidimensional Item Response Theory (MIRT) approach, using a graded response model and a complementary network approach. RESULTS: This resulted in a 19 item, four factor inventory with a good model fit, displaying good reliability and validity. CONCLUSION: The BECI is a valid measure. The simplicity, ease of application and robust psychometric properties further enhances its acceptability and usefulness as a brief measure in clinical research and trials, as well as in routine practice providing reliable and valid data on experience of caregiving in families of an individual with psychosis.

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.

A brief CBT intervention for depersonalisation/derealisation in psychosis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Depersonalisation is the experience of being detached or disconnected from one's experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically significant depersonalisation in such patient groups. This study aims to determine the feasibility and acceptability of a brief intervention targeting clinically significant depersonalisation in those who also have current psychotic symptoms. METHODS/DESIGN: The feasibility of delivering six sessions of cognitive behavioural therapy for depersonalisation in psychosis patients will be evaluated using a single-blinded randomised controlled trial with a treatment as usual control condition. Participants will be assessed at baseline and then randomised to either the treatment or control arm. Participants randomised to the treatment arm will be offered six sessions of individual cognitive behavioural therapy delivered over a maximum of 10 weeks. Therapy will focus on an individualised shared formulation of depersonalisation experiences and behavioural, cognitive, emotional regulation and thinking process strategies to decrease distress associated with depersonalisation. Participants will be assessed again at a 10-week (post-randomisation) follow-up assessment. The primary outcomes of interest will be those assessing the feasibility and acceptability of the intervention including rates of referral, eligibility and acceptance to participate; attendance at therapy sessions and completion of homework tasks; satisfaction with the intervention; maintenance of blinding; and therapist competence. Secondary outcomes will be data on clinical outcome measures of depersonalisation and positive symptoms of psychosis, anxiety, depression and post-traumatic stress. DISCUSSION: This study will determine the feasibility of delivering six sessions of cognitive behavioural therapy for individuals with current psychotic symptoms who also experience clinically significant levels of depersonalisation. The results will provide information to inform a larger randomised trial to assess intervention efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02427542.

Barriers to shared decision making in mental health care: qualitative study of the Joint Crisis Plan for psychosis.

BACKGROUND: Despite increasing calls for shared decision making (SDM), the precise mechanisms for its attainment are unclear. Sharing decisions in mental health care may be especially complex. Fluctuations in service user capacity and significant power differences are particular barriers. OBJECTIVE AND DESIGN: We trialled a form of facilitated SDM that aimed to generate patients' treatment preferences in advance of a possible relapse. The 'Joint Crisis Plan' (JCP) intervention was trialled in four mental health trusts in England between 2008 and 2011. This qualitative study used grounded theory methods to analyse focus group and interview data to understand how stakeholders perceived the intervention and the barriers to SDM in the form of a JCP. RESULTS: Fifty service users with psychotic disorders and 45 clinicians participated in focus groups or interviews between February 2010 and November 2011. Results suggested four barriers to clinician engagement in the JCP: (i) ambivalence about care planning; (ii) perceptions that they were 'already doing SDM'; (iii) concerns regarding the clinical 'appropriateness of service users' choices'; and (iv) limited 'availability of service users' choices'. Service users reported barriers to SDM in routine practice, most of which were addressed by the JCP process. Barriers identified by clinicians led to their lack of constructive engagement in the process, undermining the service users' experience. CONCLUSIONS: Future work requires interventions targeted at the engagement of clinicians addressing their concerns about SDM. Particular strategies include organizational investment in implementation of service users' choices and directly training clinicians in SDM communication processes.

Stigma- and non-stigma-related treatment barriers to mental healthcare reported by service users and caregivers.

Delayed treatment seeking for people experiencing symptoms of mental illness is common despite available mental healthcare. Poor outcomes are associated with untreated mental illness and caregivers may eventually need to seek help on the service user's behalf. More attention has recently focused on the role of stigma in delayed treatment seeking. This study aimed to establish the frequency of stigma- and non-stigma-related treatment barriers reported by 202 service users and 80 caregivers; to compare treatment barriers reported by service users and caregivers; and to investigate demographic predictors of reporting stigma-related treatment barriers. The profile of treatment barriers differed between service users and caregivers. Service users were more likely to report stigma-related treatment barriers than caregivers across all stigma-related items. Service users who were female, had a diagnosis of schizophrenia or with GCSEs (UK qualifications usually obtained at age 16) were significantly more likely to report stigma-related treatment barriers. Caregivers who were female or of Black ethnicities were significantly more likely to report stigma-related treatment barriers. Multifaceted approaches are needed to reduce barriers to treatment seeking for both service users and caregivers, with anti-stigma interventions being of particular importance for the former group.

Mental health-related discrimination as a predictor of low engagement with mental health services.

OBJECTIVE: This study aimed to test the hypothesis that mental health-related discrimination experienced by adults receiving care from community mental health teams is associated with low engagement with services and to explore the pathways between these two variables. METHODS: In this cross-sectional study, 202 adults registered with inner-city community mental health teams in the United Kingdom completed interviews assessing their engagement with mental health services (service user-rated version of the Service Engagement Scale), discrimination that they experienced because of mental illness, and other variables. Structural equation modeling was conducted to examine the relationship of experienced discrimination and service engagement with potential mediating and moderating variables, such as anticipated discrimination (Questionnaire on Anticipated Discrimination), internalized stigma (Internalized Stigma of Mental Illness Scale), stigma stress appraisal (Stigma Stress Appraisal), mistrust in services, the therapeutic relationship (Scale to Assess Therapeutic Relationships), difficulty disclosing information about one's mental health, and social support. Analyses controlled for age, race-ethnicity, and symptomatology. RESULTS: No evidence was found for a direct effect between experienced discrimination and service engagement. The total indirect effect of experienced discrimination on service engagement was statistically significant (coefficient=1.055, 95% confidence interval [CI]=.312-2.074, p=.019), mainly via mistrust in mental health services and therapeutic relationships (coefficient=.804, CI=.295-1.558, p=.019). A 1-unit increase in experienced discrimination via this pathway resulted in .804-unit of deterioration in service engagement. CONCLUSIONS: Findings indicate the importance of building and maintaining service users' trust in mental health services and in therapeutic relationships with professionals and countering the discrimination that may erode trust.

Improving Therapeutic Relationships: Joint Crisis Planning for Individuals With Psychotic Disorders.

Outcomes for individuals with psychosis remain far from acceptable. Recently, prominent psychiatrists have called for an improved understanding of the impact of social contexts, and how social contexts might influence the development and maintenance of mental health problems. A key social context for individuals with psychosis is the therapeutic relationship. As part of a trial of joint crisis planning in England, this qualitative study aimed to determine the mechanism through which joint crisis planning might affect the therapeutic relationship. Results suggest that routine processes in mental health care are affected by policy and organizational requirements for risk mitigation-aspects that undermine person-centered approaches. In contrast, strong therapeutic relationships are characterized by individualized care and reliable and respectful treatment. The Joint Crisis Plan intervention partially succeeded in reducing contextual influences on routine role enactments, facilitating the demonstration of respect and improving the therapeutic relationship.

Discrimination attributed to mental illness or race-ethnicity by users of community psychiatric services.

OBJECTIVE: This study assessed participants' experienced discrimination and their causal attributions, particularly to mental illness or race-ethnicity. METHODS: In a cross-sectional study, 202 service users with severe mental illnesses were interviewed to assess their reported experiences of discrimination. The Major Experiences of Discrimination Scale assessed major experiences of discrimination and their recency and frequency across 12 life domains and perceived reasons (attributions). The Everyday Experiences of Discrimination Scale assessed ten types of everyday discrimination and attributions for these experiences. RESULTS: Most participants (88%) reported discrimination in at least one life domain, and 94% reported ever experiencing everyday discrimination. The most common areas of major discrimination were mental health care (44%), neighbors (42%), police (33%), employment (31%), and general medical care (31%). The most common attributions for major discrimination were mental illness (57%), race-ethnicity (24%), education or income (20%), or appearance (19%). Almost half (47%) attributed experiences of major discrimination to two or more causes. No differences were found between racial-ethnic groups in overall experienced discrimination or in main attributions to mental illness. However, compared with the mixed and white groups, participants in the black group were most likely to endorse race-ethnicity as a main attribution (p<.001). CONCLUSIONS: Mental illness-related discrimination was found to be a common issue across racial-ethnic groups, and discrimination based on race-ethnicity was prevalent for the mixed and black groups. There is a need for antidiscrimination strategies that combine efforts to reduce the experience of discrimination attributed to mental illness and to race-ethnicity for racial-ethnic minority groups.

Can the therapeutic relationship predict 18 month outcomes for individuals with psychosis?

Therapeutic relationships (TRs) are considered a key component of good psychiatric care, yet its association with outcomes for individuals with psychosis remains unclear. Five hundred and sixty-nine service users with psychotic disorders and care coordinators in community settings rated their therapeutic relationship; outcomes were assessed 18 months later. In multivariate analyses, a small but significant association was found between service user ratings and instances of psychiatric hospital admissions, self harm and suicide attempts over an 18 month period. Care coordinator ratings were associated with instances of psychiatric hospital admissions and harm to others over the 18 months and level of functioning at 18 months. The differential findings and small effect size suggests that the therapeutic relationship needs further definition for this patient group in this setting. Nevertheless, clinicians should prioritise interactions that strengthen therapeutic relationships.

Anticipated and experienced discrimination amongst people with schizophrenia, bipolar disorder and major depressive disorder: a cross sectional study.

BACKGROUND: The unfair treatment of individuals with severe mental illness has been linked to poorer physical and mental health outcomes. Additionally, anticipation of discrimination may lead some individuals to avoid participation in particular life areas, leading to greater isolation and social marginalisation. This study aimed to establish the levels and clinical and socio-demographic associations of anticipated and experienced discrimination amongst those diagnosed with a schizophrenia and comparator severe mental illnesses (bipolar and major depressive disorders). METHODS: This study was a cross-sectional analysis of anticipated and experienced discrimination from 202 individuals in South London (47% with schizophrenia, 32% with depression and 20% with bipolar disorder). RESULTS: 93% of the sample anticipated discrimination and 87% of participants had experienced discrimination in at least one area of life in the previous year. There was a significant association between the anticipation and the experience of discrimination. Higher levels of experienced discrimination were reported by those of a mixed ethnicity, and those with higher levels of education. Women anticipated more discrimination than men. Neither diagnosis nor levels of functioning were associated with the extent of discrimination. Clinical symptoms of anxiety, depression and suspiciousness were associated with more experienced and anticipated discrimination respectively. CONCLUSIONS: The unfair treatment of individuals with severe mental illnesses remains unacceptably common. Population level interventions are needed to reduce levels of discrimination and to safeguard individuals. Interventions are also required to assist those with severe mental illness to reduce internalised stigma and social avoidance.

What service users with psychotic disorders want in a mental health crisis or relapse: thematic analysis of joint crisis plans.

PURPOSE: Recent legislation and guidance in England emphasises the importance of service user choice in care planning. However, it is not obvious how best to facilitate choices in care planning, and some clinicians are concerned that service users may make 'unwise' decisions. This study aimed to examine mental health service users' preferences and priorities in the event of a future mental health crisis or relapse. METHOD: Thematic analysis of 221 joint crisis plans (JCP) developed by service users and their clinical team as part of the CRIMSON randomised controlled trial. Participants had a diagnosis of a psychotic disorder, at least one psychiatric admission in the past 2 years, contact with a community mental health team, and complex care needs. RESULTS: Two major categories of preferences were identified: first the manner in which crisis care would be delivered; and second, specific treatment interventions. Most service users requested full involvement in decisions about their care, clear and consistent treatment plans, access to familiar clinicians who knew them well, and to be treated with respect and compassion. Some service users requested hospitalisation, but the majority preferred alternatives. The most frequently preferred intervention was care by a home treatment team. Just under half made a treatment refusal, the majority being for specific medications, alternatives were offered. CONCLUSIONS: Joint crisis planning resulted in service users making choices that were clinically reasonable. The technique employed by JCPs appeared to empower service users by engaging them in a productive dialogue with their clinicians.

Therapeutic relationships between mental health service users with psychotic disorders and their clinicians: a critical interpretive synthesis.

Individuals with schizophrenia and other psychotic disorders remain among the most marginalised in our communities. There has been increasing criticism of the current state of clinical treatment of such individuals as technological developments in medication provide little, if any, improvement in the lived experiences of mental health service users (SUs). In this context, there is a call for a re-orientation away from medication in the treatment of 'common factors' such as the therapeutic relationship (TR). The TR is well researched in psychotherapy settings; however, the components of beneficial TRs in the treatment of individuals with psychotic disorders are poorly understood. A critical interpretive synthesis was conducted to determine the current understanding of the TRs between individuals with psychotic disorders and their clinicians in community case management settings. A search of MEDLINE, PsycINFO, EMBASE and Social Policy and Practice Databases and grey literature between 1990 and 2011 identified 13 papers to be included in the synthesis. Three key components of beneficial TRs were identified: mutual trust, demonstration of mutual respect and shared decision-making. However, the synthesis revealed that such interactions are difficult to achieve in routine practice. The main barrier identified was a lack of clarity regarding the goal of interactions, which in turn created stakeholders with poorly defined roles and possibly oppositional needs. In this context of ambiguity, clinicians appear to de-emphasise interactions characteristic of beneficial TRs, and prioritise interactions that protect the SU and themselves in the case of a relapse. Structural symbolic interactionism is used to interpret these findings. For interactions characteristic of TRs to be prioritised in the treatment of individuals with psychotic disorders, a clearer evidence base for the importance of the TR and a clear statement of purpose of treatment are required.

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.

User-held personalised information for routine care of people with severe mental illness.

BACKGROUND: It is important to seek cost-effective methods of improving the care and outcome of those with serious mental illnesses. User-held records, where the person with the illness holds all or some personal information relating to the course and care of their illness, are now the norm in some clinical settings. Their value for those with severe mental illnesses is unknown. OBJECTIVES: To evaluate the effects of personalised, accessible, user-held clinical information for people with a severe mental illness (defined as psychotic illnesses). SEARCH METHODS: We updated previous searches by searching the Cochrane Schizophrenia Group Trials Register in August 2011. This register is compiled by systematic searches of major databases, and handsearches of journals and conference proceedings. SELECTION CRITERIA: We included all relevant randomised controlled trials (RCTs) that:i. have recruited adult participants with a diagnosis of a severe mental illness (specifically psychotic illnesses and severe mood disorders such as bipolar and depression with psychotic features); andii. compared any personalised and accessible clinical information held by the user beyond standard care to standard information routinely held such as appointment cards and generic information on diagnosis, treatment or services available. DATA COLLECTION AND ANALYSIS: Study selection and data extraction were undertaken independently by two authors and confirmed and checked by a third. We contacted authors of trials for additional and missing data. Where possible, we calculated risk ratios (RR) and 95% confidence intervals (CI). We used a random-effects model. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE. MAIN RESULTS: Four RCTs (n = 607) of user-held records versus treatment as usual met the inclusion criteria. When the effect of user-held records on psychiatric hospital admissions was compared with treatment as usual in four studies, the pooled treatment effect showed no significant impact of the intervention and was of very low magnitude (n = 597, 4 RCTs, RR 0.99 CI 0.71 to 1.38, moderate quality evidence). Similarly, there was no significant effect of the intervention in three studies which investigated compulsory psychiatric hospital admissions (n = 507, 4 RCTs, RR 0.64 CI 0.37 to 1.10, moderate quality evidence). Other outcomes including satisfaction and mental state were investigated but pooled estimates were not obtainable due to skewed or poorly reported data, or only being investigated by one study. Two outcomes (violence and death) were not investigated by the included studies. Two important randomised studies are ongoing. AUTHORS' CONCLUSIONS: The evidence gap remains regarding user-held, personalised, accessible clinical information for people with psychotic illnesses for many of the outcomes of interest. However, based on moderate quality evidence, this review suggests that there is no effect of the intervention on hospital or outpatient appointment use for individuals with psychotic disorders. The number of studies is low, however, and further evidence is required to ascertain whether these results are mediated by the type of intervention, such as involvement of a clinical team or the type of information included.

Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial.

BACKGROUND: Many mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request 'reasonable adjustments'. There have been no intervention studies to support decision-making about disclosure to an employer. AIMS: To determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid. METHOD: In this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014). RESULTS: We recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement -22.7 (s.d. = 15.2) v. -11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03). CONCLUSIONS: The observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial.

BACKGROUND: The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. METHODS: Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. FINDINGS: 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58-1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference -1·28 [95% CI -2·56 to -0·01, p=0·049]). Qualitative data supported this finding. INTERPRETATION: Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. FUNDING: Medical Research Council UK and the National Institute for Health Research.