Search

BackgroundSevere COVID anxiety describes people whose experiences of the COVID-19 pandemic are overwhelming, and have lead to patterns of behaviours that add little protective benefit but are at the expense of other priorities in life. It appears to be a complex social and psychological phenomenon, influenced by demographic and social factors. Identifying subgroups of people with severe COVID anxiety would better place clinicians to assess and support this distress where indicated.MethodsMeasurement tools assessing depression, generalised and health anxiety, obsessive-compulsive symptoms, personality difficulty and alcohol use from 284 people living in United Kingdom with severe COVID anxiety were explored with latent profile analysis. Further analyses examined the associations of identified clusters with demographic and social factors and daily functioning, quality of life and protective behaviours.ResultsA model with 4 classes provided the best fit. Distinct patterns of psychopathology emerged which were variably associated with demographic factors and COVID behaviours.LimitationsGiven the complex aetiology of COVID anxiety a number of factors which might better cluster subgroups are likely to have gone uncollected. Moreover, using data collected at a single time-point limits these results’ ability to conclude whether observed relationships were the product of the pandemic or longstanding.ConclusionsPeople living with severe COVID anxiety are a heterogenous group. This analysis adds to evidence that certain health behaviours and demographic factors are inextricably linked to poor mental health in people with COVID anxiety, and that targeting health behaviours with specific intervention might be beneficial.

Background More than half of people who use antipsychotic medication for psychosis report having sexual dysfunction. The REMEDY trial aimed to find out if switching antipsychotic medication provides an effective way to reduce sexual dysfunction among people with psychosis. We set out to recruit 216 participants over a two-year period, but recruitment was stopped after an extended 12-month pilot phase, during which we recruited only 10 participants. As part of a nested process evaluation, we conducted qualitative interviews with front-line clinicians to examine barriers to recruitment to the trial. Methods We developed a semi-structured interview schedule to explore staff views on factors that influenced whether they referred potential participants to the study. We interviewed a purposive sample of 51 staff from four National Health Service (NHS) Trusts in England, ensuring a range of different backgrounds, seniority, and levels of involvement in the trial. Audio recordings of interviews were transcribed for verbatim, and data were analysed using an inductive approach to thematic analysis. Results Nine interconnected themes were generated. Six themes concerned barriers to recruitment; including; prioritising patients’ mental stability, mutual discomfort and embarrassment about discussing a “taboo” subject, and concerns about unintended consequences of asking people with psychosis about their sexual functioning. Three themes, including the quality of treatment relationships and strategies for opening dialogue suggested ways to improve recognition of these “hidden” side effects. Conclusion The identification and management of sexual dysfunction among people with psychosis are not priorities for mental health services in England at this time. Many staff working in front-line services feel unprepared and uncomfortable asking people with psychosis about these problems. While greater use of screening tools may improve the identification of sexual dysfunction among people with psychosis, the evaluation and implementation of interventions to manage them will continue to be challenging unless NHS leaders and senior clinicians demonstrate greater commitment to changing current clinical practice. Trial registration Current Controlled Trials ISRCTN12307891.

PurposeThe purpose of the article is to present standard set of outcomes for people with personality disorder (PD), in order to facilitate patient outcome measurement worldwide.MethodsThe International Consortium for Health Outcomes Measurement (ICHOM) gathered a multidisciplinary international working group, consisting of 16 experts, including clinicians, nurses, psychologists, methodologists and patient representatives, to develop a standard set of outcome measures for people with PD. The Delphi method was used to reach consensus on the scope of the set, outcome domains, outcome measures, case-mix variables and time points for measuring outcomes in service users. For each phase, a project team prepared materials based on systematic literature reviews and consultations with experts.ResultsThe working group decided to include PD, as defined by International Classification of Diseases 11th revision (ICD-11). Eleven core outcomes and three optional outcomes across four health domains (mental health, behaviour, functioning and recovery) were defined as those relevant for people with PD. Validated measures for the selected outcomes were selected, some covering more than one outcome. Case-mix variables were aligned to other ICHOM mental health standard sets and consisted of demographic factors and those related to the treatment that people received. The group recommended that most outcomes are measured at baseline and annually.ConclusionThe international minimum standard set of outcomes has the potential to improve clinical decision making through systematic measurement and comparability. This will be key in improving the standard of health care for people with PD across the world.

Background: There are longstanding concerns regarding physical health inequalities for people with psychotic disorders. In recent years concerted efforts have been made to address these. \ud Aims: To examine whether recent national initiatives in England have led to improvements in the physical health of people with schizophrenia and related psychoses. \ud Methods: Secondary analysis of data from multiple rounds of a national audit of services for people with psychosis, conducted over a 9-year period. Proportions of patients in ‘good health’ according to seven discrete measures, and one composite measure derived from national standards, were compared between each round of the audit. \ud Results: The proportion of patients in overall ‘good health’ under the care of ‘Early Intervention in Psychosis’ (EIP) teams increased between 2014 and 2019 (OR=4.65, 95% CI 3.32 to 6.52, P

Background The association of workplace factors on mental health of healthcare workers (HCWs) during the COVID-19 pandemic needs to be urgently established. This will enable governments and policy-makers to make evidence-based decisions. This international study reports the association between workplace factors and the mental health of HCWs during the pandemic. Methods An international, cross-sectional study was conducted in 41 countries. The primary outcome was depressive symptoms, derived from the validated Patient Health Questionnaire-2 (PHQ-2). Multivariable logistic regression identified factors associated with mental health outcomes. Inter-country differences were also evaluated. Results A total of 2527 responses were received, from 41 countries, including China (n = 1213; 48.0%), UK (n = 891; 35.3%), and USA (n = 252; 10.0%). Of all participants, 1343 (57.1%) were aged 26 to 40 years, and 2021 (80.0%) were female; 874 (34.6%) were doctors, and 1367 (54.1%) were nurses. Factors associated with an increased likelihood of depressive symptoms were: working in the UK (OR = 3.63; CI = [2.90–4.54]; p p p p p = 0.040). Workplace factors associated with depressive symptoms were: redeployment to Intensive Care Unit (ICU) (OR = 1.67; CI = [1.14–2.46]; p = 0.009); redeployment with perceived unsatisfactory training (OR = 1.67; CI = [1.32–2.11]; p p p p Conclusion This is the first international study, demonstrating that workplace factors, including PPE availability, staff training pre-redeployment, and provision of mental health support, are significantly associated with mental health during COVID-19. Governments, policy-makers and other stakeholders need to ensure provision of these to safeguard HCWs’ mental health, for future waves and other pandemics.

Background Individuals with Complex Emotional Needs (CEN) services, a working description to refer to the needs experienced by people who may have been diagnosed with a “personality disorder”, face premature mortality, high rates of co-morbidity, service user and treatment costs. Service provision for this population is recurrently identified as needing to be transformed: there are serious concerns about quality, accessibility, fragmentation of the service system and the stigma and therapeutic pessimism service users encounter. Understanding clinician perspectives is vital for service transformation, as their views and experiences shed light on potential barriers to achieving good care, and how these might be overcome. In this study, we aimed to explore these views. Methods We used a qualitative interview design. A total of fifty participants from a range of professions across specialist and generic community mental health services across England who provide care to people with CEN took part in six focus groups and sixteen one-to-one interviews. We analysed the data using a thematic approach. Findings Main themes were: 1) Acknowledging the heterogeneity of needs: the need for a person-centred care approach and flexibility when working with CEN, 2) ‘Still a diagnosis of exclusion’: Exploring the healthcare provider-level barriers to providing care, and 3) Understanding the exclusionary culture: exploring the system-based barriers to providing care for CEN. Across these themes, staff highlighted in particular the need for care that was person-centred, relational, empathic, and trauma informed. Major barriers to achieving this are stigmatising attitudes and behaviour towards people with CEN, especially in generic mental health services, lack of development of coherent service systems offering clear long-term pathways and ready access to high quality treatment, and lack of well-developed structures for staff training and support. Discussion Overall, the findings point towards clinician views as generally congruent with those of service users, reinforcing the need for priorities towards systemwide change to ensure that best practice care is provided for people with CEN. Particularly prominent is the need to put in place systemwide training and support for clinicians working with CEN, encompassing generic and specialist services, and to challenge the stigma still experienced throughout the system. Conclusions Staff working with this service user group report that delivering best practice care requires services to be flexible, integrated, and sustainably funded, and for staff to be supported through ongoing training and supervision.

Background Patients who undergo psychological treatment can report both negative and positive effects, but evidence of factors influencing the likelihood of negative effects is limited. Aims To identify aspects of the organisation and delivery of secondary care psychological treatment services that are associated with patient experiences of negative effects. Method Cross-sectional survey of people with anxiety and depression who ended psychological treatment delivered by 50 NHS trusts in England. Respondents were asked about how their treatment was organised and delivered and whether they experienced lasting negative effects. Results Of 662 respondents, 90 (14.1%) reported experiencing lasting negative effects. People over the age of 65 were less likely than younger respondents to report negative effects. There was an association between reporting neutral or negative effects and not being referred at what respondents considered to be the right time (OR = 1.712, 95% CI = 1.078–2.726), not receiving the right number of sessions (OR = 3.105, 95% CI = 1.934–4.987), and not discussing progress with their therapist (OR 2.063, 95% CI = 1.290–3.301). Conclusions One in seven patients who took part in this survey reported lasting negative effects from psychological treatment. Steps should be taken to prepare people for the potential for negative experiences of treatment, and progress reviewed during therapy in an effort to identify and prevent negative effects.

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.

Background Diagnoses of personality disorder are prevalent among people using community secondary mental health services. Identifying cost-effective community-based interventions is important when working with finite resources. Aims To assess the cost-effectiveness of primary or secondary care community-based interventions for people with complex emotional needs who meet criteria for a diagnosis of personality disorder to inform healthcare policy-making. Method Systematic review (PROSPERO: CRD42020134068) of databases. We included economic evaluations of interventions for adults with complex emotional needs associated with a diagnosis of personality disorder in community mental health settings published before 18 September 2019. Study quality was assessed using the CHEERS statement. Results Eighteen studies were included. The studies mainly evaluated psychotherapeutic interventions. Studies were also identified that evaluated altering the setting in which care was delivered and joint crisis plans. No strong economic evidence to support a single intervention or model of community-based care was identified. Conclusions Robust economic evidence to support a single intervention or model of community-based care for people with complex emotional needs is lacking. The strongest evidence was for dialectical behaviour therapy, with all three identified studies indicating that it is likely to be cost-effective in community settings compared with treatment as usual. More robust evidence is required on the cost-effectiveness of community-based interventions on which decision makers can confidently base guidelines or allocate resources. The evidence should be based on consistent measures of costs and outcomes with sufficient sample sizes to demonstrate impacts on these.

Funder: Public Health Research Programme; doi: http://dx.doi.org/10.13039/501100001921; Grant(s): NIHR-PHR: 16/122/35, Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children’s well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0–10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3–18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. Trial registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500.

ObjectivesTo identify aspects of the organisation and delivery of acute inpatient services for people with dementia that are associated with shorter length of hospital stay.Design and settingRetrospective cohort study of patients admitted to 200 general hospitals in England and Wales.Participants10 106 people with dementia who took part in the third round of National Audit of Dementia.Main outcome measureLength of admission to hospital.ResultsThe median length of stay was 12 days (IQR=6–23 days). People with dementia spent less time in hospital when discharge planning was initiated within 24 hours of admission (estimated effect −0.24, 95% CI: −0.29 to −0.18, pConclusionsThe way that services for inpatients with dementia are delivered can influence how long they spend in hospital. Initiating discharge planning within the first 24 hours of admission may help reduce the amount of time that people with dementia spend in hospital.

Objectives There is a lack of independent longitudinal evidence on the factor structure and validity of the Zanarini Rating Scale for Borderline Personality Disorder (ZAN‐BPD). This study aimed to investigate the dimensionality of ZAN‐BPD and its conceptual consistency over time. Methods Adult BPD participants (n = 276) were recruited for a multicentre, two‐arm randomised clinical trial with ZAN‐BPD measured at baseline and follow up at 12, 24 and 52 weeks. The construct and stability of the ZAN‐BPD across 52 weeks was examined through a measurement equivalence/invariance procedure via Exploratory Structural Equation Modelling. Results Factor analysis results showed that the ZAN‐BPD had a bi‐2 factor structure that was stable over 52 weeks with a general factor and two specific factors. Factor loadings for eight of the nine items were greater for the general factor than the two specific factors. Factor 1 contrasts externalising distress with internalising distress. Factor 2 contrasts depression and self‐destruction with interpersonal anxiety and conflict. Conclusion ZAN‐BPD is a conceptually and empirically valid measure of total BPD symptom severity in BPD patients over time suitable for use in clinical trials. Two factors related to the expression of distress and self‐harm may be utilised as possible predictors of outcome.

OBJECTIVES: Dialectical behaviour therapy (DBT) and mentalization-based therapy (MBT) are widely used evidence-based psychological treatments for borderline personality disorder (BPD). The study aimed to establish evidence on common and unique, and helpful and unhelpful, treatment processes. \ud \ud DESIGN: Mixed-methods. \ud \ud METHODS: In-depth qualitative interview data on patient experiences during treatment were combined with quantitative outcome measures in 73 patients diagnosed with a personality disorder and receiving DBT or MBT. \ud \ud RESULTS: Across both DBT and MBT, accounts of learning not to react impulsively, learning to question one's thoughts and assumptions, learning to communicate more effectively, and exposure to painful emotions that may previously have been avoided were each associated with less baseline-adjusted self-harm at the end of treatment. Difficulties in interacting with other group members were more likely to be described by patients receiving MBT than DBT, whilst difficulties in the therapeutic relationship were equally common. Both of these types of difficult experience were associated with higher baseline-adjusted levels of BPD traits and emotional dysregulation, at the end of the 12-month study period. \ud \ud CONCLUSIONS: The findings identify novel evidence of common therapeutic processes across DBT and MBT that may help to reduce self-harm. The findings also highlight the potential iatrogenic effect of difficulties in the alliance with therapists or with other group members. This underscores the importance of listening to patients' voices about what they are finding difficult during therapy and working to address these relational challenges, so that the patient is able to progress and make best use of the treatment. \ud \ud PRACTITIONER POINTS: \ud \ud - Regardless of whether dialectical behaviour therapy or mentalization based therapy is used, helping service-users to learn not to react impulsively, to question their thoughts and assumptions, and to communicate more effectively, may be beneficial for reducing self-harm.\ud \ud - Across both types of therapy, exposure to painful emotions is a difficult experience for service-users, but may also be beneficial for reducing self-harm, if carefully managed. \ud \ud - Whilst service-users' experiences across both types of therapy have much in common, accounts of mentalization based therapy stand out in more often describing both helpful and unhelpful experiences of interactions with therapy group members. \ud \ud - Service-users across both types of therapy report the benefits of learning intrapersonal mentalization skills, whilst recipients of mentalization based therapy uniquely extend this to learning interpersonal mentalization. \ud \ud - Ruptures in the therapeutic alliance, and distressing interactions with group members, may be iatrogenic and must be carefully managed.

Aims and methodWe conducted a secondary analysis of data from the National Audit of Psychosis to identify factors associated with use of community treatment orders (CTOs) and assess the quality of care that people on CTOs receive.ResultsBetween 1.1 and 20.2% of patients in each trust were being treated on a CTO. Male gender, younger age, greater use of in-patient services, coexisting substance misuse and problems with cognition predicted use of CTOs. Patients on CTOs were more likely to be screened for physical health, have a current care plan, be given contact details for crisis support, and be offered cognitive–behavioural therapy.Clinical implicationsCTOs appear to be used as a framework for delivering higher-quality care to people with more complex needs. High levels of variation in the use of CTOs indicate a need for better evidence about the effects of this approach to patient care.

Levels of awareness and treatment of depression in older adults admitted to acute hospitals are unclear. This study aims to examine the proportion of older adults diagnosed with depression in acute hospitals, treatment, referral, and communication between secondary and primary healthcare services following discharge. Retrospective examination of records of 766 older adults admitted to 27 acute hospitals in England was carried out. Ninety-eight (12.7%, 95% confidence interval (CI) = 10.6–15.3) records included a diagnosis of depression of which eight (1.0%, 95% CI = 0.5–2.0) had a new diagnosis made during their hospital admission. All newly diagnosed and 76 (84.4%, 95% CI = 75.5–90.5) of those with an existing diagnosis of depression were prescribed antidepressant medication. Six (75.0%, 95% CI = 40.9–92.8) of those with a new diagnosis, and 21 (23.3%, 95% CI = 15.8–33.0) with an existing diagnosis of depression were referred to liaison psychiatry. References to mental health were made in 50 (51.0%, 95% CI = 41.2–60.6) discharge letters sent to primary care. Very few older adults admitted to acute hospitals in this study were diagnosed with depression during their inpatient stay. Opportunities for improving the mental and physical health of such patients appear to be being missed.

Introduction Some people are so anxious about COVID-19 that it impairs their functioning. However, little is known about the course of severe COVID-19 anxiety or what can be done to help people who experience it. Methods and analysis Cohort study with a nested feasibility trial with follow-up at 3 and 6 months. We recruited 306 people who were aged 18 and over, lived in the UK and had severe COVID-19 anxiety (indicated by a score of 9 or more on the Coronavirus Anxiety Scale (CAS)). To take part in the nested feasibility trial, participants also had to have a score of 20 or more on the Short Health Anxiety Inventory. We excluded people from the trial if they had had COVID-19 within the previous 4 weeks, if they were currently self-isolating or if they were already receiving psychological treatment. We publicised the study nationally through adverts, social media and posts on message boards. We also recruited participants via clinicians working in primary and secondary care NHS services in London. All those in the active arm will be offered 5–10 sessions of remotely delivered modified cognitive–behavioural therapy for health anxiety (CBT-HA). We will examine the proportion of participants who remain above threshold on the CAS at 3 and 6 months and factors that influence levels of COVID-19 anxiety over 6 months using mixed effects logistic regression. The key feasibility metrics for the nested trial are the level of uptake of CBT-HA and the rate of follow-up. Ethics and dissemination Approved by Leicester Central Research Ethics Committee (reference: 20/EM/0238). The results of the study will be published in peer-reviewed scientific journals. Trial registration number NCT14973494.

Objective: While incidence rates of depression and anxiety disorders in the elderly have been comprehensively investigated, the incidence rates of other mental disorders have rarely been researched. The incidence rate and predictors of various mental disorders in the elderly were evaluated in different European and associated countries. Methods: A cross-sectional and longitudinal multi-centre survey of Diagnostic and Statistical Manual of Mental Disorders (4th ed.) diagnoses was conducted in different European and associated countries (Germany, Italy, Spain, Switzerland, the United Kingdom and Israel) to collect data on the prevalence and incidence of mental disorders in the elderly. The sample size of the longitudinal wave was N = 2592 elderly. Results: The overall 1-year incidence rate for any mental disorder in the elderly is 8.65%. At 5.18%, any anxiety disorder had the highest incidence rate across all diagnostic groups. The incidence rate for any affective disorder was 2.97%. The lowest incidence rates were found for agoraphobia (1.37%) and panic disorder (1.30%). Risk factors for the development of any mental disorder were never having been married, no religious affiliation, a higher number of physical illnesses and a lower quality of life. Conclusion: In comparison to other studies, lower incidence rates for any affective disorder and middle-range incidence for any anxiety disorder were found. To the authors’ knowledge, no prior studies have reported 1-year incidence rates for somatoform disorder, bipolar disorder and substance misuse in community-dwelling elderly. These findings indicate the need to raise awareness of psychosocial problems in the elderly and to ensure adequate availability of mental health services.

Background Antisocial personality disorder (ASPD), although associated with very significant health and social burden, is an under-researched mental disorder for which clinically effective and cost-effective treatment methods are urgently needed. No intervention has been established for prevention or as the treatment of choice for this disorder. Mentalization-based treatment (MBT) is a psychotherapeutic treatment that has shown some promising preliminary results for reducing personality disorder symptomatology by specifically targeting the ability to recognize and understand the mental states of oneself and others, an ability that is compromised in people with ASPD. This paper describes the protocol of a multi-site RCT designed to test the effectiveness and cost-effectiveness of MBT for reducing aggression and alleviating the wider symptoms of ASPD in male offenders subject to probation supervision who fulfil diagnostic criteria for ASPD. Methods Three hundred and two participants recruited from a pool of offenders subject to statutory supervision by the National Probation Service at 13 sites across the UK will be randomized on a 1:1 basis to 12 months of probation plus MBT or standard probation as usual, with follow-up to 24 months post-randomization. The primary outcome is frequency of aggressive antisocial behaviour as assessed by the Overt Aggression Scale – Modified. Secondary outcomes include violence, offending rates, alcohol use, drug use, mental health status, quality of life, and total service use costs. Data will be gathered from police and criminal justice databases, NHS record linkage, and interviews and self-report measures administered to participants. Primary analysis will be on an intent-to-treat basis; per-protocol analysis will be undertaken as secondary analysis. The primary outcome will be analysed using hierarchical mixed-effects linear regression. Secondary outcomes will be analysed using mixed-effects linear regression, mixed-effects logistic regression, and mixed-effects Poisson models for secondary outcomes depending on whether the outcome is continuous, binary, or count data. A cost-effectiveness and cost-utility analysis will be undertaken. Discussion This definitive, national, multi-site trial is of sufficient size to evaluate MBT to inform policymakers, service commissioners, clinicians, and service users about its potential to treat offenders with ASPD and the likely impact on the population at risk. Trial registration ISRCTN 32309003. Registered on 8 April 2016.

BackgroundDiagnoses of “personality disorder” are prevalent among people using community secondary mental health services. Whilst the effectiveness of a range of community-based treatments have been considered, as the NHS budget is finite, it is also important to consider the cost-effectiveness of those interventions.AimsTo assess the cost-effectiveness of primary or secondary care community-based interventions for people with complex emotional needs that meet criteria for a diagnosis of “personality disorder” to inform healthcare policy making.MethodSystematic review (PRESPORO #: CRD42020134068) of five databases, supplemented by reference list screening and citation tracking of included papers. We included economic evaluations of interventions for adults with complex emotional needs associated with a diagnosis of ‘personality disorder’ in community mental health settings published between before 18 September 2019. Study quality was assessed using the CHEERS statement. Narrative synthesis was used to summarise study findings.ResultsEighteen studies were included. The studies mainly evaluated psychotherapeutic interventions. Studies were also identified which evaluated altering the setting in which care was delivered and joint crisis plans. No strong economic evidence to support a single intervention or model of community-based care was identified.ConclusionThere is no robust economic evidence to support a single intervention or model of community-based care for people with complex emotional needs. The review identified the strongest evidence for Dialectical Behavioural Therapy with all three identified studies indicating the intervention is likely to be cost-effective in community settings compared to treatment as usual. Further research is needed to provide robust evidence on the cost-effectiveness of community-based interventions upon which decision makers can confidently base guidelines or allocate resources.

Background Questions have been raised regarding differences in the standards of care that patients receive when they are admitted to or discharged from in-patient units at weekends. Aims To compare the quality of care received by patients with anxiety and depressive disorders who were admitted to or discharged from psychiatric hospital at weekends with those admitted or discharged during the ‘working week’. Method Retrospective case-note review of 3795 admissions to in-patient psychiatric wards in England. Quality of care received by people with depressive or anxiety disorders was compared using multivariable regression analyses. Results In total, 795 (20.9%) patients were admitted at weekends and 157 (4.8%) were discharged at weekends. There were minimal differences in quality of care between those admitted at weekends and those admitted during the week. Patients discharged at weekends were less likely to be given sufficient notification (48 h) in advance of being discharged (OR = 0.55, 95% CI 0.39–0.78), to have a crisis plan in place (OR = 0.65, 95% CI 0.46–0.92) or to be given medication to take home (OR = 0.45, 95% CI 0.30–0.66). They were also less likely to have been assessed using a validated outcome measure (OR = 0.70, 95% CI 0.50–0.97). Conclusions There is no evidence of a ‘weekend effect’ for patients admitted to psychiatric hospital at weekends, but the quality of care offered to those who were discharged at weekends was relatively poor, highlighting the need for improvement in this area.

Background The numerous health risks of excessive alcohol consumption are well documented. Individuals at risk of harm from alcohol consumption can be identified through alcohol screening tools; however, there is limited research regarding their use in general dental practices.Methods Data were collected as part of a feasibility trial evaluating delivery of brief alcohol advice in general dental practices in North London. Patient demographics and health-related behaviours were collected, and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) tool was used to assess alcohol consumption patterns.Results The analytical sample comprised 552 dental patients, of whom approximately half (46%) were drinking alcohol at hazardous levels. Males, younger adults, those who consumed red meat weekly and smokers all had significantly increased risks of excessive alcohol consumption. Smokers were more likely to consume excessive levels of alcohol irrespective of smoking frequency. Notable sex differences in alcohol consumption were identified, with males being more likely to consume alcohol frequently and in larger quantities than females.Conclusion The AUDIT-C tool can be used in general dental practice to screen for harmful levels of alcohol consumption. Clear associations exist between patient demographics, health behaviours and excessive alcohol consumption.

BACKGROUND: It is known that personality has an influence on the outcome of mental state disorders, but detailed studies on its long-term impact are few. We examined the influence of personality status on the 8-year outcome of health anxiety and its relationship to the effects of cognitive behaviour therapy in a randomized controlled trial. AIMS: This study aims to examine both the usefulness of the diagnosis of personality disorder and an additional measure of pathological dependence, in predicting the outcome of medical patients with health anxiety treated with cognitive behaviour therapy. Because the influence of personality is often shown in the long term, these assessments covered the period of 8 years after randomization. An additional aim is to examine the costs of different levels of personality dysfunction in each treatment group. METHOD: Personality dysfunction, using both ICD-10 and ICD-11 classifications of severity, was assessed at baseline by interview in a randomized controlled trial. Patients were also assessed for pathological dependence using the Dependent Personality Questionnaire, also scored along a severity dimension. Four hundred forty-four patients from medical clinics with pathological health anxiety were treated with a modified form of cognitive behaviour therapy for health anxiety (CBT-HA) or standard care. Total costs over follow-up were calculated from hospital data and compared by personality group. RESULTS: At baseline, 381 (86%) had some personality dysfunction, mainly at the lower level of personality difficulty (not formally a disorder). One hundred eighty four (41%) had a personality disorder. A similar proportion was found with regard to dependent personality. Using the ICD-10 classification, 153 patients (34.6%) had a personality disorder, with 83 (54.2%) having anxious or dependent personality disorder, 20 (13.1%) having an anankastic disorder, but also with 66 (43.1%) having mixed disorder. During initial treatment, those with personality disorder adhered more closely to CBT-HA, and after 8 years, they had a significantly better outcome than those with personality difficulty and no personality disorder (p

Background People with Borderline Personality Disorder (BPD) have limited access to long term psychological therapies. Briefer interventions have been developed but trial evidence to support their use has not been reviewed. Aims To examine whether psychological interventions for adults with BPD of six months duration or less improve symptoms, mood, self-harm, suicidal behaviour, and service use. Methods The protocol was prospectively registered (PROSPERO CRD42017063777). Database searches were conducted up to April 2020. Inclusion, data extraction and risk of bias were assessed in duplicate. We identified 27 randomised controlled trials. We conducted random-effects meta-analyses sub-grouping data into delivery method, additional support, and comparison type. Results High levels of bias were found for attrition and reporting. Heterogeneity was high in some pooled data. Borderline symptom reductions were greatest for interventions including additional support (SMD. -1.23, 95% C.I. -2.13, −0.33). Planned generic support may be as effective as specialist interventions for borderline symptoms (SMD = −0.11, 95% C.I. -0.51, 0.29) and social functioning (SMD = −0.16., 95% C.I. -0.65, 0.33). Follow-up was limited and direct comparison with post-intervention results was unreliable. Conclusions Short-term interventions may be effective. Access to additional support has an impact on outcomes. It is unclear if symptomatic change is sustained.

Background Recent major concerns about the quality of healthcare delivered to older adults have been linked to inadequate staffing and a lack of patient-centred care. Patient experience is a key component of quality care - yet there has been little research on whether and how staffing levels and staffing types affect satisfaction amongst older adult hospital inpatients. This study aimed to evaluate the association between registered nurse and healthcare assistant staffing levels and satisfaction with care amongst older adult hospital inpatients, and to test whether any positive effect of higher staffing levels is mediated by staff feeling they have more time to care for patients. Methods Survey data from 4928 inpatients aged 65 years and older and 2237 medical and nursing staff from 123 acute and community medical wards in England, United Kingdom (UK) was collected through the Royal College of Psychiatrist’s Elder Care Quality Mark. The cross-sectional association between staffing ratios and older adult patient satisfaction, and mediation by staff perceived time to care, was evaluated using multi-level modelling, adjusted for ward type and with a random effect for ward identity. Results Higher numbers of patients per healthcare assistant were associated with poorer patient satisfaction (adjusted β = − 0.32, 95% CI − 0.55 to 0.10, p Conclusions Older adult hospital patients may particularly value the type of care provided by healthcare assistants, such as basic personal care and supportive communication. Additionally, higher availability of healthcare assistants may contribute to all ward staff feeling more able to spend time with patients. However, high availability of registered nurses has been shown in other research to be vital for ensuring quality and safety of patient care. Future research should seek to identify the ideal balance of registered nurses and healthcare assistants for optimising a range of outcomes amongst older adult patients.

Introduction Concerns have been raised about the quality of inpatient care received by patients with a diagnosis of personality disorder. Objectives The aim of this study was to examine the quality of care received by inpatients with an anxiety or depressive disorder, comparing subgroups with or without a co‐morbid personality disorder. Method We used a retrospective case‐note review of 3 795 patients admitted to inpatient psychiatric wards in England, utilizing data from the National Clinical Audit of Anxiety and Depression. Data were gathered on all acute admissions with an anxiety or depressive disorder over a 6‐month period, for a number of measures reflecting quality of care derived from national standards. Association of coexisting personality disorder with quality of care was investigated using multivariable regression analyses. Results Four hundred sixteen (11.0%) of the patients had a co‐co‐morbid diagnosis of personality disorder. Patients with personality disorder were less likely to have been asked about prior responses to treatment in their initial assessment (odds ratio (OR) = 0.67, 95% confidence interval (CI) 0.50 to 0.89, p = 0.007). They were less likely to receive adequate notice in advance of their discharge (OR = 0.87, 95% CI 0.65 to 0.98, p = 0.046). They were more likely to be prescribed medication at the point of discharge (OR = 1.52, 95% CI 1.02 to 2.09, p = 0.012) and less likely to have been provided with information about the medicines they were taking (OR = 0.86, 95% CI 0.69 to 0.94, p = 0.048). In addition, the carers of patients with co‐morbid personality disorder were less likely to have been provided with information about available support services (OR = 0.73, 95% CI 0.51 to 0.93, p = 0.045). Conclusion We found evidence of poorer quality of care for patients with co‐morbid personality disorder who were admitted to psychiatric hospital for treatment of anxiety or depressive disorders, highlighting the need for improved clinical care in this patient group.

Background To describe the clinical activity patterns and nature of interventions of hospital-based liaison psychiatry services in England. Methods Multi-site, cross-sectional survey. 18 acute hospitals across England with a liaison psychiatry service. All liaison staff members, at each hospital site, recorded data on each patient they had face to face contact with, over a 7 day period. Data included location of referral, source of referral, main clinical problem, type of liaison intervention employed, staff professional group and grade, referral onto other services, and standard assessment measures. Results A total of 1475 face to face contacts from 18 hospitals were included in the analysis, of which approximately half were follow-up reviews. There was considerable variation across sites, related to the volume of Emergency Department (ED) attendances, number of hospital admissions, and work hours of the team but not to the size of the hospital (number of beds). The most common clinical problems were co-morbid physical and psychiatric symptoms, self-harm and cognitive impairment. The main types of intervention delivered were diagnosis/formulation, risk management and advice. There were differences in the type of clinical problems seen by the services between EDs and wards, and also differences between the work conducted by doctors and nurses. Almost half of the contacts were for continuing care, rather than assessment. Eight per cent of all referrals were offered follow up with the LP team, and approximately 37% were referred to community or other services. Conclusions The activity of LP services is related to the flow of patients through an acute hospital. In addition to initial assessments, services provide a wide range of differing interventions, with nurses and doctors carrying out distinctly different roles within the team. The results show the volume and diversity of LP work. While much clinical contact is acute and confined to the inpatient episode, the LP service is not defined solely by an assessment and discharge function; cases are often complex and nearly half were referred for follow up including liaison team follow up.

The children of parents with severe personality difficulties have greater risk of significant mental health problems. Existing care is poorly co-ordinated, with limited effectiveness. A specialised parenting intervention may improve child and parenting outcomes, reduce family morbidity and lower the service costs.To develop a specialised parenting intervention for parents affected by severe personality difficulties who have children with mental health problems and to conduct a feasibility trial.A pragmatic, mixed-methods design to develop and pilot a specialised parenting intervention, Helping Families Programme-Modified, and to conduct a randomised feasibility trial with process evaluation. Initial cost-effectiveness was assessed using UK NHS/Personal Social Services and societal perspectives, generating quality-adjusted life-years. Researchers collecting quantitative data were masked to participant allocation.Two NHS mental health trusts and concomitant children's social care services.Parents who met the following criteria: (1) the primary caregiver of the index child, (2) aged 18-65 years, (3) have severe personality difficulties, (4) proficient in English and (5) capable of providing informed consent. Index children who met the following criteria: (1) aged 3-11 years, (2) living with index parent and (3) have significant emotional/behavioural difficulties. Exclusion criteria were (1) having coexisting psychosis, (2) participating in another parenting intervention, (3) receiving inpatient care, (4) having insufficient language/cognitive abilities, (5) having child developmental disorder, (6) care proceedings and (7) index child not residing with index parent.The Helping Families Programme-Modified - a 16-session intervention using structured, goal-orientated strategies and collaborative therapeutic methods to improve parenting, and child and parent functioning. Usual care - standard care augmented by a single psychoeducational session.Trial feasibility - rates of recruitment, eligibility, allocation, retention, data completion and experience. Intervention acceptability - rates of acceptance, completion, alliance (Working Alliance Inventory-Short Revised) and experience. Outcomes - child (assessed via Concerns About My Child, Eyberg Child Behaviour Inventory, Child Behaviour Checklist-Internalising Scale), parenting (assessed via the Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale), parent (assessed via the Symptom Checklist-27), and health economics (assessed via the Client Service Receipt Inventory, EuroQol-5 Dimensions).The findings broadly supported trial feasibility using non-diagnostic screening criteria. Parents were mainly referred from one site (75.0%). Site and participant factors delayed recruitment. An estimate of eligible parents was not obtained. Of the 86 parents referred, 60 (69.7%) completed screening and 48 of these (80.0%) were recruited. Participants experienced significant disadvantage and multiple morbidity. The Helping Families Programme-Modified uptake (87.5%) was higher than usual-care uptake (62.5%). Trial retention (66.7%, 95% confidence interval 51.6% to 79.6%) exceeded the a priori rate. Process findings highlighted the impact of random allocation and the negative effects on retention. The Helping Families Programme-Modified was acceptable, with duration of delivery longer than planned, whereas the usual-care condition was less acceptable. At initial follow-up, effects on child and parenting outcomes were detected across both arms, with a potential outcome advantage for the Helping Families Programme-Modified (effect size range 0.0-1.3). For parental quality-adjusted life-years, the Helping Families Programme-Modified dominated usual care, and child quality-adjusted life-years resulted in higher costs and more quality-adjusted life-years. At second follow-up, the Helping Families Programme-Modified was associated with higher costs and more quality-adjusted life-years than usual care. For child quality-adjusted life-years, when controlled for baseline EuroQol-5 Dimensions, three-level version, usual care dominated the Helping Families Programme-Modified. No serious adverse events were reported.The Helping Families Programme-Modified is an acceptable specialised parenting intervention. Trial methods using non-diagnostic criteria were largely supported. For future work, a definitive efficacy trial should consider site selection, recruitment methods, intervention efficiency and revised comparator condition.Current Controlled Trials ISRCTN14573230.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inParents affected by personality difficulties experience strong, overwhelming emotions and struggle in their personal and social relationships. These difficulties can interfere with their ability to provide stable, safe and warm parenting, which increases the risk of their children developing mental health problems. This research developed the Helping Families Programme-Modified, a new parenting intervention designed to help parents with severe personality difficulties who have children with mental health problems. Parents received 16 home-based appointments to learn new parenting skills and improve their children’s difficulties. The research assessed how the Helping Families Programme-Modified worked in practice and the viability of evaluation methods. A short questionnaire assessing personality difficulties, rather than a lengthy diagnostic interview, was more effective and acceptable for identifying parents who may benefit from the Helping Families Programme-Modified. Parents taking part had high levels of personal, family and social problems. This slowed the rate at which parents agreed to take part in the evaluation and lengthened the intervention period. The research tested parent agreement to being randomly allocated to receive either the Helping Families Programme-Modified or usual care plus a specially designed parenting appointment. Although this random allocation was feasible, parents were disappointed when they did not receive the Helping Families Programme-Modified. They often felt overwhelmed by family difficulties and lacked other suitable services. These parents were less likely to take up the additional parenting appointment available or to provide subsequent research information, which affected the certainty of the research findings. Parents receiving the Helping Families Programme-Modified or usual care reported improvements, with a potentially greater impact on parents and children, and better acceptability, for the new intervention. Parents generally supported the tailored, home-based approach of the Helping Families Programme-Modified, and they valued its content, therapist skills and persistence. It was uncertain whether the new intervention increased or reduced service costs. These results will be used to plan the most suitable methods for a large-scale evaluation of the Helping Families Programme-Modified.

Background An ageing population worldwide needs to investigate quality of life (QoL) and level of functioning (LoF) in the elderly and its associated variables. We aimed to study the relationship between Quality of Life (QoL) and Level of Functioning (LoF) in an elderly population in Europe. Method As part of the Ment_Dis65+ European Project, 3142 community-dwelling adults aged 65–84 years in six countries were assessed by using the adaptation for the elderly of the Composite International Diagnostic Interview (CIDI65+) to provide psychiatric diagnosis according to the International Classification of Diseases (10th edition) (ICD-10 Classification of Mental and Behavioural Disorders). Socio-demographic and clinical interviews, and two self-report tools, the World Health Organization QoL assessment (WHO QoL BREF), to assess QoL, and the WHO Disability Assessment Schedule -II (WHODAS-II), to assess LoF, were also administered. Results Most subjects reported good levels of QoL (56.6%) and self-rated health (62%), with no or mild disability (58.8%). There was a linear decrease of the QoL and the LoF by increase of age. Elderly with ICD-10 mental disorder (e.g. somatoform, affective and anxiety disorders) had poorer QoL and lower LoF. There were a number of predictors of lower levels of QoL and disability, including both socio-demographic variables (e.g. male gender, increase in age, poor financial situation, retirement, reduced number of close significant others), ICD-10 psychiatric diagnosis (mainly anxiety, somatoform disorders) and presence of medical disorders (mainly heart and respiratory diseases). Conclusions The study indicates that QoL and LoF were quite acceptable in European elderly people. A series of variables, including psychiatric and somatic disorders, as well as socio-demographic factor influenced in a negative way both QoL and LoF. More specific links between mental health, social and health services dedicated to this segment of the population, should be implemented in order to provide better care for elderly people with conditions impacting their QoL and functioning.

Background National guidance cautions against low-intensity interventions for people with personality disorder, but evidence from trials is lacking. Aims To test the feasibility of conducting a randomised trial of a low-intensity intervention for people with personality disorder. Method Single-blind, feasibility trial (trial registration: ISRCTN14994755). We recruited people aged 18 or over with a clinical diagnosis of personality disorder from mental health services, excluding those with a coexisting organic or psychotic mental disorder. We randomly allocated participants via a remote system on a 1:1 ratio to six to ten sessions of Structured Psychological Support (SPS) or to treatment as usual. We assessed social functioning, mental health, health-related quality of life, satisfaction with care and resource use and costs at baseline and 24 weeks after randomisation. Results A total of 63 participants were randomly assigned to either SPS (n = 33) or treatment as usual (n = 30). Twenty-nine (88%) of those in the active arm of the trial received one or more session (median 7). Among 46 (73%) who were followed up at 24 weeks, social dysfunction was lower (−6.3, 95% CI −12.0 to −0.6, P = 0.03) and satisfaction with care was higher (6.5, 95% CI 2.5 to 10.4; P = 0.002) in those allocated to SPS. Statistically significant differences were not found in other outcomes. The cost of the intervention was low and total costs over 24 weeks were similar in both groups. Conclusions SPS may provide an effective low-intensity intervention for people with personality disorder and should be tested in fully powered clinical trials.

Objectives: Delirium is associated with increased mortality in older adults. National guidance recommends that all people with dementia who are admitted to hospital are screened for delirium. However, the impact of screening for delirium among inpatients with dementia has not been examined. This study aims to examine this relationship.Methods: Secondary analysis of data from 10,047 patients admitted to 199 hospitals in England and Wales that took part in the third round of the National Audit of Dementia. Data on patients with dementia who died during their admission were compared with those who survived. We calculated odds of mortality among those who were screened for delirium, received cognitive testing, and, in those with delirium, an expert clinical review.Results: The mean age of study patients was 84 years (SD = 7.9), 40.1% were male and 82.1% white British. 1,285 patients (12.8%) died during their admission to hospital. Overall, 4,466 (44.5%) patients were screened for delirium, of whom 2,603 (58.6%) screened positive. The odds of mortality were lower in patients who underwent delirium screening (OR: 0.79, 95% confidence interval (CI): 0.69-0.90) and in those receiving cognitive testing (OR: 0.71, 95%CI: 0.61-0.82).Conclusion: These results demonstrate that, among people with dementia who are admitted to hospital, screening for delirium and assessment of cognitive functioning are associated with lower mortality. While we cannot be certain that these associations are causal, the findings support efforts that are being made to increase levels of screening for delirium among people with dementia who are admitted to hospital.

BackgroundSpecialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties.ObjectiveConduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention.DesignPragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates.SettingsTwo National Health Service health trusts and local authority children’s social care.ParticipantsParents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties.InterventionHFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session.OutcomesPrimary feasibility outcome: participant retention rate. Secondary outcomes: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). Secondary outcomes: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O’Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation.ResultsFindings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3).ConclusionHFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported.Trial registration numberISRCTN14573230

Background Peer-review networks aim to help services to improve the quality of care they provide, however, there is very little evidence about their impact. We conducted a cluster randomized controlled trial of a peer-review quality network for low-secure mental health services to examine the impact of network membership on the process and outcomes of care over a 12 month period. Methods Thirty-eight low secure units were randomly allocated to either the active intervention (participation in the network n = 18) or the control arm (delayed participation in the network n = 20). A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at 12 month follow up. The primary outcome measure was the quality of the physical environment and facilities of the services. The secondary outcomes included: safety of the ward, patient mental wellbeing and satisfaction with care, staff burnout, training and supervision. We hypothesised that, relative to control wards, the quality of the physical environment and facilities would be higher on wards in the active arm of the trial 12 months after randomization. Results The difference in the primary outcome between the groups was not statistically significant (4.1; 95% CI [− 0.2, 8.3] p = 0.06). The median number of untoward incidents rose in control services and remained the same at the member of the network (Difference between members and non-members = 0.55; 95% IC [0.29, 1.07] p = 0.08). At follow up, a higher proportion of staff in the active arm of the trial indicated that they felt safe on the ward relative to those in the control services (p = 0.04), despite reporting more physical assaults (p = 0.04). Staff working in services in the active arm of the trial reported higher levels of burnout relative to those in the control group. No difference was seen in patient outcomes. Conclusions We did not find evidence that participation in a peer-review network led to marked changes in the quality of the physical environment of low secure mental health services at 12 months. Future research should explore the impact of accreditation schemes and examine longer term outcomes of participation in such networks. Trial registration ISRCTN79614916. Retrospectively registered 28 March 2014.

BackgroundNo drug treatments are currently licensed for the treatment of borderline personality disorder (BPD). Despite this, people with this condition are frequently prescribed psychotropic medications and often with considerable polypharmacy. Preliminary studies have indicated that mood stabilisers may be of benefit to people with BPD.ObjectiveTo examine the clinical effectiveness and cost-effectiveness of lamotrigine for people with BPD.DesignA two-arm, double-blind, placebo-controlled individually randomised trial of lamotrigine versus placebo. Participants were randomised via an independent and remote web-based service using permuted blocks and stratified by study centre, the severity of personality disorder and the extent of hypomanic symptoms.SettingSecondary care NHS mental health services in six centres in England.ParticipantsPotential participants had to be aged ≥ 18 years, meet diagnostic criteria for BPD and provide written informed consent. We excluded people with coexisting psychosis or bipolar affective disorder, those already taking a mood stabiliser, those who spoke insufficient English to complete the baseline assessment and women who were pregnant or contemplating becoming pregnant.InterventionsUp to 200 mg of lamotrigine per day or an inert placebo. Women taking combined oral contraceptives were prescribed up to 400 mg of trial medication per day.Main outcome measuresOutcomes were assessed at 12, 24 and 52 weeks after randomisation. The primary outcome was the total score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. The secondary outcomes were depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment and adverse events. Higher scores on all measures indicate poorer outcomes.ResultsBetween July 2013 and October 2015 we randomised 276 participants, of whom 195 (70.6%) were followed up 52 weeks later. At 52 weeks, 49 (36%) of those participants prescribed lamotrigine and 58 (42%) of those prescribed placebo were taking it. At 52 weeks, the mean total ZAN-BPD score was 11.3 [standard deviation (SD) 6.6] among those participants randomised to lamotrigine and 11.5 (SD 7.7) among those participants randomised to placebo (adjusted mean difference 0.1, 95% CI –1.8 to 2.0;p = 0.91). No statistically significant differences in secondary outcomes were seen at any time. Adjusted costs of direct care for those prescribed lamotrigine were similar to those prescribed placebo.LimitationsLevels of adherence in this pragmatic trial were low, but greater adherence was not associated with better mental health.ConclusionsThe addition of lamotrigine to the usual care of people with BPD was not found to be clinically effective or provide a cost-effective use of resources.Future workFuture research into the treatment of BPD should focus on improving the evidence base for the clinical effectiveness and cost-effectiveness of non-pharmacological treatments to help policy-makers make better decisions about investing in specialist treatment services.Trial registrationCurrent Controlled Trials ISRCTN90916365.FundingFunding for this trial was provided by the Health Technology Assessment programme of the National Institute for Health Research (NIHR) and will be published in full inHealth Technology Assessment; Vol. 22, No. 17. See the NIHR Journals Library website for further project information. The Imperial Biomedical Research Centre Facility, which is funded by NIHR, also provided support that has contributed to the research results reported within this paper. Part of Richard Morriss’ salary during the project was paid by NIHR Collaboration for Leadership in Applied Health Research and Care East Midlands.

Background Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID). Objective To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months). Design A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster. Setting Community ID services in England. Participants Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist – Community total score (ABC-CT)]. Interventions Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm. Main outcome measures Carer-reported changes in challenging behaviour as measured by the ABC-CT over 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up. Results A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CT between the intervention and control arms [mean difference –2.14, 95% confidence interval (CI) –8.79 to 4.51; p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm, n = 19; control arm, n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months’ follow-up (n = 184), the mean ABC-CT difference between arms was not significant (–3.70, 95% CI –9.25 to 1.85; p = 0.191). The initial cost-effectiveness of the intervention dissipated over time. Limitations The main limitations were low treatment fidelity and reach of the intervention. Conclusions Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice. Trial registration This study is registered as NCT01680276. 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. 22, No. 15. See the NIHR Journals Library website for further project information.

Background: Data from case series suggest that clozapine may benefit inpatients with borderline personality disorder (BPD), but randomised trials have not been conducted. Methods: Multicentre, double-blind, placebo-controlled trial. We aimed to recruit 222 inpatients with severe BPD aged 18 or over, who had failed to respond to other antipsychotic medications. We randomly allocated participants on a 1:1 ratio to receive up to 400 mg of clozapine per day or an inert placebo using a remote web-based randomisation service. The primary outcome was total score on the Zanarini Rating scale for Borderline Personality Disorder (ZAN-BPD) at 6 months. Secondary outcomes included self-harm, aggression, resource use and costs, side effects and adverse events. We used a modified intention to treat analysis (mITT) restricted to those who took one or more dose of trial medication, using a general linear model fitted at 6 months adjusted for baseline score, allocation group and site. Results: The study closed early due to poor recruitment and the impact of the COVID-19 pandemic. Of 29 study participants, 24 (83%) were followed up at 6 months, of whom 21 (72%) were included in the mITT analysis. At 6 months, 11 (73%) participants assigned to clozapine and 6 (43%) of those assigned to placebo were still taking trial medication. Adjusted difference in mean total ZAN-BPD score at 6 months was -3.86 (95% Confidence Intervals = -10.04 to 2.32). There were 14 serious adverse events; 6 in the clozapine arm and 8 in the placebo arm of the trial. There was little difference in the cost of care between groups. Interpretation: We recruited insufficient participants to test the primary hypothesis. The study findings highlight problems in conducting placebo-controlled trials of clozapine and in using clozapine for people with BPD, outside specialist inpatient mental health units. Trial registration ISRCTN18352058. https://doi.org/10.1186/ISRCTN18352058

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.