This study addresses a critical gap in the evidence base for cost-effective psychological interventions for antisocial personality disorder (ASPD) in forensic settings by presenting a full trial-based economic evaluation of mentalisation-based treatment plus probation as usual (MBT-ASPD + PAU), compared to PAU alone, for males with ASPD convicted of an offence in England and Wales. The economic evaluation adopted a societal perspective, incorporating costs to health care, the criminal justice system, and the wider societal impact of offending. Outcomes were assessed 24 months post-randomisation. The primary cost-utility analysis compared costs with quality-adjusted life years (QALYs) derived from the EQ-5D-5L, while a secondary cost-effectiveness analysis compared costs with aggression outcomes measured by the Overt Aggression Scale - Modified (OAS-M). Although missing data limited definitive conclusions regarding service use, available data suggest that participants in the PAU group spent more time in custody than those in the MBT-ASPD + PAU group. Utility scores and quality of life showed minimal variation over follow-up, with no significant differences between groups. Overall costs were lower in the MBT-ASPD + PAU group, though not statistically significant. Over the 24-month period, MBT-ASPD + PAU was associated with both reduced costs and lower aggression (as reflected in OAS-M scores), indicating that each unit reduction in aggression yielded a cost saving of approximately £93. For QALYs, MBT-ASPD + PAU appeared cost-effective compared to PAU across all values a decision-maker may be willing to pay for improvements in outcome. These findings provide preliminary evidence for the potential economic value of MBT-ASPD + PAU in a forensic ASPD population, particularly in relation to aggression reduction and the associated cost savings. Trial registrationThis trial is registered with ISRCTN (ISRCTN 32309003).

Background There is increasing evidence that sedentary behaviour has a detrimental effect on health and well-being. At least 1.2 million people living in England have had a stroke, and longer-term outcomes are poor for many. Stroke survivors are particularly sedentary compared to age-matched controls. Objective(s) We sought to enhance health outcomes for stroke survivors through the development and evaluation of strategies to reduce sedentary behaviour. Research questions related to identification of existing evidence; exploration of capabilities, opportunities and motivation related to sedentary behaviour after stroke; determining whether an intervention developed using principles of coproduction was feasible and whether trial design issues could be addressed before assessing the clinical and cost-effectiveness of the intervention. A pragmatic definitive trial to assess the developed intervention was planned; due to the COVID-19 pandemic, the trial was reduced to an external pilot trial. Design and methods Five overlapping workstreams were undertaken: Systematic review to collate the quantitative and qualitative evidence relating to sedentary behaviour in adults including survivors of stroke. Observations and semistructured interviews in two stroke services to inform the coproduction process and explore the capability, opportunity and motivation to address sedentary behaviours. Development of an intervention to reduce sedentary behaviour through use of coproduction principles in Yorkshire and Scotland. A single-arm feasibility trial in three services to refine the developed intervention and clarify trial procedures. A multicentre external pilot cluster randomised controlled trial evaluating the intervention incorporating embedded process and economic evaluations. Setting and participants Stroke services (inclusive of primary, secondary and community care provision) across England and Scotland. Participants were stroke survivors and their carers, and healthcare professionals in the included stroke services. Intervention An intervention to reduce sedentary behaviour was coproduced in workstream 3, informed by information obtained in workstream 1 and workstream 2. In workstream 4, groups (healthcare professionals, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention. The intervention (called Get Set Go) is a whole-service intervention designed to be implemented and embedded within routine practice. Delivery commences in the inpatient stroke unit setting and continues into the community for at least 12 weeks post discharge. The intervention focuses on: (1) educating staff and stroke survivors; (2) preparing and enabling staff to support and encourage stroke survivors to stand and move more in everyday stroke care; (3) encouraging stroke survivors to monitor their own standing and moving, Main outcome measures The primary outcome was stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months post registration. The key secondary outcome was mean daily sedentary time (minutes) at 12 months post registration using activity monitor (activPAL) data. Data sources Literature reviews; observations and semistructured interviews in stroke services; feasibility and trial outcomes. Results Workstream 1: two quantitative (n = 85 studies and n = 30, respectively) and two qualitative systematic reviews (n = 30, n = 17) were undertaken and published. Workstream 2: observational (in inpatient and community settings) and interview work was undertaken in two sites (Yorkshire and Scotland). Workstream 3: five coproduction workshops were conducted concurrently in Edinburgh and Yorkshire (n = 43 participants), and a provisional intervention was developed. Workstream 4: implementation groups in three services, who operationalised and implemented the intervention. Trial procedures were refined and a concurrent qualitative data collection guided adaptation of the intervention. Workstream 5: 15 English stroke services were randomised (n = 8 treatment, n = 7 control) and recruited 334 stroke survivors (n = 249 retained at 12-month follow-up). Results did not indicate potential effectiveness of Get Set Go compared with usual care [adjusted mean difference in Nottingham Extended Activities of Daily Living scale at 12 months (95% confidence interval) p = −1.76 (−7.63 to 4.25), p = 0.530]. No significant differences between arms were found in secondary outcomes. The exploratory findings from this external pilot study suggest that the Get Set Go intervention is unlikely to be cost-effective. Limitations Due to coronavirus disease discovered in 2019, workstream 5 was reduced to become an external pilot trial with reduced 24-month follow-up. This trial was therefore not powered to detect definitive outcomes. Conclusions Participants appreciated the relevance of the work and components of the intervention developed. Implementing service change in the inpatient setting is challenging. Future work Work is ongoing to tailor the intervention to different patient types based on a secondary analysis of the patient interview data using ideal-type analysis methods. Development of a consistent messaging strategy relating to sedentary behaviour and survivors of stroke is required. Trial registration This trial is registered as ISRCTN 12246326, registered on 7 August 2019 and ISRCTN82280581, registered on 1 April 2020. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20019) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 14. See the NIHR Funding and Awards website for further award information. Plain language summary Too much time spent in sedentary behaviours (sitting/lying down) is linked with ill health and mortality. Stroke survivors are particularly sedentary, spending up to 80% of their waking day sitting or lying down. We developed and evaluated an intervention to reduce sedentary behaviour for stroke survivors through five workstreams. We updated reviews of previous and current research in workstream 1. In workstream 2, we interviewed staff and observed what happens on stroke units and during therapy sessions in patients’ homes. We also interviewed stroke survivors and their carers, to explore their thoughts on sedentary behaviour, and what might help or hinder this. In workstream 3, through a series of meetings, using information from workstream 1 and workstream 2, ideas and action plans (an intervention) for reducing time spent sitting/lying were produced. The intervention (called Get Set Go) was refined by working with three stroke services in workstream 4. The intervention included training and materials for staff and stroke survivors to encourage stroke survivors to undertake and monitor their own standing and moving in the stroke unit and after discharge. We undertook a preliminary exploration of the developed intervention in 15 stroke services; 8 were randomly allocated to deliver Get Set Go and the other 7 continued providing their usual care to all stroke survivors. We aimed to explore whether Get Set Go was likely to improve stroke survivors’ ability to complete extended activities of daily living in the first year after stroke. A total of 334 stroke survivors were included in the trial. In this exploratory work, no significant differences were found between groups in any of the measured outcomes and Get Set Go seems unlikely to be cost-effective, but our work was limited by the pandemic and did not include sufficient participants to detect a difference. Participants and staff appreciated the relevance of the work and components of the intervention. Scientific summary Background There is increasing evidence that sedentary behaviour defined as any waking behaviour characterised by low energy expenditure ≤ 1.5 metabolic equivalent of tasks while in a sitting or reclining posture has a detrimental effect on health and well-being. Stroke survivors are particularly sedentary. The aim of this programme was to enhance health and disability outcomes for stroke survivors through the development and evaluation of strategies to both reduce overall time spent sedentary and break up long bouts of sedentary behaviour. The objectives were to: Ensure that intervention development was informed by up-to-date review of the quantitative and qualitative evidence. Inform development of an intervention by observations and qualitative investigation of sedentary behaviour with stroke survivors, their carers and health professionals, including exploring their capability, opportunities and motivation to address this behaviour. Use coproduction principles to develop intervention strategies to reduce sedentary behaviour in people after stroke. Test the implementation of the intervention and clarify trial design components in a feasibility study in three stroke services. Conduct a large pragmatic cluster randomised trial evaluation of the developed intervention with internal pilot, process evaluation and cost-effectiveness analysis. Due to the unprecedented effects of the coronavirus disease discovered in 2019 (COVID-19) pandemic on the NHS, this trial was reduced in size and scope to become an external pilot trial with time-limited follow-up of participants. Methods Stroke survivors and their carers participated in the development of this research programme and contributed throughout. We engaged with local stroke groups and co-applicant Gill Carter assisted in all workstreams (WSs). In addition, our methods were purposively inclusive of stroke survivors’ input through qualitative reviews (WS1), interviews (WS2) and directly in our coproduction work (WS3), intervention refinement (WS4) and review of the delivered intervention (WS5). Workstream 1 Four systematic reviews of the quantitative and qualitative evidence relating to sedentary behaviour were undertaken to ensure our work was founded on strong evidence which included identifying relevant behaviour change techniques and barriers and facilitators to intervention implementation. Workstream 2 Observations (in hospital and in the community) and semistructured interviews in two stroke services were undertaken. Interviews with stroke survivors and their carers, at 6 and 9 months post stroke, and with members of the multidisciplinary team explored the capability, opportunity and motivation to address sedentary behaviours from their perspectives. Thematic analysis was undertaken for all observational data; interviews were analysed using Framework Analysis. Workstream 3 Informed by information gathered in the previous two WSs and behaviour change approaches, coproduction principles were utilised to develop a tailored intervention to reduce sedentary behaviour after stroke. Workstream 4 A single-arm feasibility trial was undertaken in three stroke services to: clarify content and methods of delivery of the intervention; assess fidelity; and capture learning from, and acceptability to, staff and participating stroke survivors. Iterative refinement of the intervention was undertaken by service-led implementation groups and captured through Table of Change methodology. Trial procedures relating to patient eligibility criteria and recruitment processes were clarified. Outcome measures were administered including a provisional Client Service Receipt Inventory to capture resource use data for the health economic evaluation. Workstream 5 A multicentre pilot cluster randomised controlled trial with embedded process and economic evaluations was undertaken in 15 stroke services to provide a preliminary exploration of the effectiveness of Get Set Go (GSG) in improving the ability to complete extended activities of daily living (ADL) and reduce sedentary behaviour in the first year after stroke. The process evaluation, including observations of training and practice; interviews with staff, patients and carers; and documentary analysis, was undertaken to explore implementation of the intervention, how it was experienced and understood by recipients and providers and identify any potential moderators and mediators of the intervention effect. The health economic analysis explored core resource use and costs associated with delivering the intervention including impacts on wider care. Results Workstream 1 Two quantitative (n = 85 studies and n = 30, respectively) and qualitative systematic reviews (n = 30, n = 17) were undertaken and published. An evidence gap was confirmed. The findings indicated that interventions might be effective in reducing time spent sedentary, but intervention strategies to encourage sustainability of effects are needed. Interventions targeting a reduction in sedentary behaviour need to be flexible with context awareness. Workstream 2 Over 132 hours of observations, semistructured interviews with stroke survivors (n = 31), carers (n = 12) and staff (n = 30) across the two services were undertaken. The physical and social environment, perceptions of stroke survivors’ physical and psychological capability to move, and routinised practices enacted by staff facilitate an expectation to be sedentary in the inpatient setting. This is often carried over when stroke survivors leave hospital. Staff, stroke survivors and carers reported they recognised the value of reducing sedentary behaviour and wanted to learn about safe and appropriate methods for doing so. Workstream 3 Five face-to-face coproduction workshops comprising key stakeholders (stroke survivors, carers, inpatient and community healthcare professionals, and public health practitioners n = 43 overall) were convened and undertaken concurrently in Yorkshire and Scotland. Informed by findings from earlier WSs, a prototype tailored intervention with delivery strategies was developed, called Get, Set, Go, standing and moving more after stroke. A logic model and Template for Intervention Description and Replication checklist were also completed. Workstream 4 Three stroke services participated in this feasibility work; the intervention was delivered as a service-wide initiative, supported by purposely convened implementation groups. Thirty-nine stroke survivors were recruited to complete outcome measures; follow-up was low due to the start of the COVID-19 pandemic. There were some missing data in outcome assessment and some components of the health economic data collection tool were poorly completed, resulting in refinement of these measures prior to WS5. The activPAL (activity monitor) was shown to be feasible for use, although need for training refinement was highlighted. There were no safety concerns. Qualitative observations and interviews (n = 28 staff; n = 12 patients) informed changes to the fidelity and adherence data collection methods. Refinement of the intervention was undertaken on review of the Table of Change. Intervention The intervention (GSG) comprised four main components: Education aimed at staff, stroke survivors and carers. Staff guidance (assessment tools) and materials (posters, prompt magnets) to support stroke survivors integrating standing and moving more into daily routines. A guide (with monitoring forms) to support stroke survivors to stand and move more after stroke, including information for their family, friends and informal carers. Environmental adaptation. A key component of the intervention was therapy assessment of ability to stand by way of a traffic light system (red, amber, green) with a linked ‘prescription’ for standing and moving provided, to inform and encourage survivors of stroke to stand and move more. Stroke survivors are reassessed regularly and the prescription amended as required with detailed information and self-complete monitoring forms in the accompanying guide. Workstream 5 A total of 15 clusters were randomised; 8 were randomised to deliver GSG plus usual care (UC) and 7 were randomised to deliver UC. Intervention training took place over a 24-month period primarily online due to COVID-19 restrictions supported by in-person visits when allowed. In total, 103 training sessions were delivered to 381 staff. A total of 5984 patients were screened: 1029 (17.2% of screened) were approached, 969 (94.2% of approached, 16.2% of screened) were eligible and 334 (34.6% of those eligible; 5.6% of those screened) were registered into the trial; 181 participants were registered to the GSG arm and 153 to the UC arm. Participants across the treatment arms were similar in terms of age, gender and living arrangements. Stroke survivors had an average age of 69 years (range 23–98) and 60.4% were female. However, there were some differences between arms in ethnicity of participants; 94.4% were White British in the GSG arm compared to 85.4% in the UC arm. Ethnicity differences could have been due to regional variations between the recruiting sites. Participants in each arm had similar levels of disability, stroke severity and cognitive impairment. Of the 331 participants, 96 (29.0%) participants withdrew from at least one element of the study; 56 (31.1%) in the GSG arm and 40 (26.5%) in the UC arm. Baseline characteristics were very similar between participants who withdrew and did not withdraw. The mean Nottingham Extended Activities of Daily Living (NEADL) score pre-stroke was 57.4, with slightly greater independence in the UC arm (58.9 compared to 56.1). As a preliminary exploration of effectiveness, we report at 6 months after stroke, the mean NEADL score was approximately 45.3 with a median score of 50.0 and a wide interquartile range from 31 to 61 points. Mean NEADL score at 12 months was 43.3 (18.87) in the GSG arm versus 47.4 (17.11) in the control arm. The mean difference in the cluster-level adjusted residuals for NEADL score between the two arms at 12 months was −1.76 [95% confidence interval (CI) −7.63 to 4.25, p-value 0.530]. Independence increased in both arms for the subset of participants followed up at 24 month. At both 6 and 12 months, the UC arm had slightly greater independence. The mean difference in the cluster-level adjusted residuals for mean daily sedentary time in minutes between the two arms at 12 months was −29.6 (95% CI −33.71 to 92.81, p-value 0.322). The difference was not statistically significant for mean daily sedentary time. No significant differences between arms were found in secondary outcomes. This pilot trial was not powered to detect a difference. Process evaluation Observations (11 training, 44 intervention, 17 control) and interviews [n = 52 staff (40 intervention, 12 control); and n = 27 patients (17 intervention, 10 control)] were undertaken across four time points each separated by approximately 3 months, alongside documentary analysis. Key findings Many patients and staff valued learning and emphasised that the core message of movement after stroke is important. Intervention implementation and awareness occurred inconsistently among patients and staff. Inpatients were largely inactive outside of therapy sessions, many felt their movement was restricted, and some viewed GSG as giving permission to move. While the intervention provided initial patient motivation, it was not suited for all and its use decreased over time as patient priorities shifted or they felt they no longer needed it. Staff supported implementation using additional local setup and ‘Champion’ roles, but felt the message was sometimes lost in trial paperwork. Movement occurs in the context of safety and comorbidity, within a complex system and pressured environment. Exploratory economic evaluation Resource use patterns at baseline were similar between groups for formal services but the GSG group used more unpaid care (24 vs. 4 hours on average); this greater use of unpaid care was also evident at follow-ups (122 vs. 78 hours on average at 12 months), coupled with higher use of hospital services. Consequently, total costs were higher in the GSG group across baseline (£2710 vs. £1452) and all follow-ups (£11,140 vs. £8989 at 12 months). The GSG group showed higher variability which means there was wider cost dispersion and implies a highly skewed cost distribution with a standard deviation twice as the mean at 12 months follow-up. Utility estimates also suggested lower quality-adjusted life-years (QALYs) for the GSG group over the follow-up period. In combination, from both NHS/Personal Social Services and societal perspectives, costs were higher in the GSG group, while outcomes measured in QALYs were worse, suggesting in this exploratory work that the GSG intervention is unlikely to be cost-effective. This is further evidenced by the bootstrapped replications, which show that almost all replications lie in the northwest quadrant of the cost-effectiveness plane. Conclusions Awareness of the detrimental effects of sedentary behaviour has increased over the lifetime of this grant. Our research question remains valid, as no effective interventions have yet emerged for this client group. Our extensive literature reviews and multisite qualitative work informed our programme and will assist others in this area; similarly, the detailed operationalisation of the process of coproduction will assist others using this methodology. We successfully developed a robust meaningful intervention (GSG), using coproduction involving a range of stakeholders, which was compatible with routine practice. Unfortunately, our work was considerably impacted by COVID-19, and we were unable to complete the planned definitive trial. The exploratory findings from this pilot study must be viewed with caution but suggest that the GSG intervention is unlikely to be cost-effective. Important learning has emerged however; stroke survivors and staff appreciated and understood the relevance of the work and components of the intervention developed. Survivors of stroke and healthcare professionals did not always understand the concepts of sedentary behaviour and the importance of breaking up sedentariness throughout the day. This is an important public health message for everyone and requires clear dissemination. Despite best efforts, take-up was patchy with other members of the multidisciplinary team perceiving encouraging movement to be the role of the therapy team rather than a service initiative. Efforts to reduce sedentary behaviour may conflict with other initiatives aimed to enhance patient safety such as falls risk policies. There is a challenge when to start such an intervention, either in busy inpatient settings to ensure behaviour change messages are provided early or later when the situation is less frantic, but habits may already be formed. The overlay of paperwork to capture implementation and costs added complexity (and some confusion) and perhaps reduced implementation. Activity monitors proved acceptable and this work provides one of the largest ever data sets in this population. Patient-completed outcome measures are burdensome for participants, clinical and research staff. Within the economic evaluation, a comparison between self-reported resource use data and routine secondary care records highlights a need for careful strategies for data collection. It could be helpful to evaluate interventions using hybrid data collection approaches that make use of routine data and Sentinel Stroke National Audit Programme. Recommendations for research While this external pilot trial was successfully concluded, take-up of the intervention was patchy and participants’ dropout greater than we would wish. Refinement of the intervention implementation and development of a more efficient trial design are required prior to a definitive trial. The GSG intervention remains a potentially useful and important tool. Further work is being conducted based on a secondary analysis of the patient interview data using ideal-type analysis methods, to produce recommendations for how GSG can be tailored to different types of survivors of stroke. Future analysis could explore trajectories and clustering to determine whether GSG works for some patient groups and not for others. The timing of delivery of this and other self-management interventions remains problematic. Further work should explore clinical staff’s views of assessing stroke survivors’ ability to self-manage aspects of their life after stroke. Trial registration This trial is registered as ISRCTN 12246326, registered on 7 August 2019 and ISRCTN82280581, registered on 1 April 2020. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0615-20019) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 14. See the NIHR Funding and Awards website for further award information.

BACKGROUND:Long-term psychological treatments are recommended for people with personality disorder. Brief interventions are increasingly delivered but are of uncertain benefit. We aimed to investigate the effectiveness of a brief individual psychological intervention for people with probable personality disorder over a 12-month period. METHODS:The Structured Psychological Support (SPS) study was a multicentre, researcher-masked, randomised controlled superiority trial, conducted in seven mental health Trusts in England: Avon and Wiltshire Mental Health Partnership National Health Service (NHS) Trust, Central and North West London NHS Foundation Trust, Coventry and Warwickshire Partnership NHS Trust, Derbyshire Healthcare NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust, Mersey Care NHS Foundation Trust, and Oxford Health NHS Foundation Trust. Participants were aged 18 years or older and had probable personality disorder identified by meeting a threshold of 4 or more on the Standardised Assessment of Personality Abbreviated Scale. We excluded those who: did not consent; had a co-existing psychotic disorder; or were already receiving psychological treatment. We assessed whether participants met criteria for borderline personality disorder using the Structured Clinical Interview for Axis II Personality Disorders and whether they had co-existing complex post-traumatic stress disorder using the International Trauma Questionnaire. We randomly assigned participants to up to ten sessions of SPS plus treatment-as-usual or enhanced treatment-as-usual (allocation ratio 1·15:1), using an independent remote system. Researchers assessing outcomes were masked to group allocation. SPS comprises up to ten individual sessions of personalised psychological support, which includes psychoeducation and psychological skills derived from evidence-based treatments (dialectical behaviour therapy and mentalisation-based treatment). Sessions were usually delivered on a fortnightly basis by staff with previous experience of working with people with personality disorder. The primary outcome was social functioning at 12 months measured using the Work and Social Adjustment Scale (WSAS). Data were analysed using multilevel mixed effects general linear regression on an intention-to-treat basis. We used multiple imputation to address missing outcomes. We undertook a parallel health economic evaluation, which included cost-effectiveness and cost-utility analyses. People with lived experience were involved in the design of the research and in the writing process. The trial was prospectively registered (ISRCTN13918289) and is now complete. FINDINGS:Between Feb 7, 2023, and Jan 31, 2024, 569 potential participants were referred for study inclusion, 34 were deemed ineligible, 56 declined to participate, and 127 were not approached. 352 potential participants provided consent, of whom 16 were deemed ineligible or withdrew. 336 participants were randomly assigned to either SPS (n=180) or treatment-as-usual (n=156). 251 (75%) participants were female, 75 (22%) were male, and ten (3%) were non-binary or other. The mean age was 34·8 years (SD 13·2; range 18-68) and 281 (84%) participants were White. 152 (84%) participants in the SPS group and 132 (85%) in the control group completed the 12-month follow-up. There was no difference between groups for the primary outcome of WSAS score (standardised coefficient 0·12 [95% CI -2·14 to 2·38]; p=0·92). The probability that SPS is cost-effective was 0·34-0·39. There were 36 serious adverse events affecting 17 participants in the SPS group and 16 in the treatment-as-usual group. None were judged to be related to study procedures. Two study participants died during the 12-month follow period, both in the SPS group. INTERPRETATION:We found no difference in social functioning over the course of 1 year among people offered a brief psychological intervention, and no evidence of cost-effectiveness. These data highlight the importance of improving access to longer-term evidence-based psychological treatment programmes for people with personality disorder. FUNDING:National Institute for Health and Care Research.

Introduction Post-COVID syndrome (PCS) is an ongoing legacy of the SARS-CoV-2 pandemic. Defined as symptoms persisting beyond 12 weeks following SARS-CoV-2 infection unexplained by an alternative diagnosis, many individuals continue to experience symptoms for months post-infection. Fatigue, breathlessness, cognitive difficulties and sleep disturbances are all commonly reported, frequently impairing daily functioning and quality of life. Acceptance and commitment therapy (ACT), which enhances psychological flexibility and supports values-based behaviour change, has shown effectiveness across long-term health conditions. This protocol describes the evaluation of Balance-ACT as a novel, adapted ACT-based intervention to address the complex physical and psychological needs of people with PCS.Methods and analysis A randomised controlled trial (RCT), co-developed with people with PCS, will evaluate the efficacy and cost-effectiveness of Balance-ACT for PCS. A total of 196 adults with PCS will be recruited from specialist long COVID services within secondary care across NHS organisations in England and randomised 1:1 to Balance-ACT or treatment as usual (TAU). Balance-ACT consists of 10 therapist-delivered sessions delivered over 13 weeks. TAU comprises brief educational videos and a self-help leaflet for COVID-19 recovery. Outcomes will be assessed at 7, 14 and 20 weeks post-randomisation. The primary outcome is health-related quality of life, measured using the SF-36 Physical Component Score at 14 weeks post randomisation. Secondary outcomes include physical health-related quality of life at 20 weeks, perceived fatigue, clinical global improvement, sleep disturbance, cognitive functioning, depressive symptoms, anxiety symptoms, post-exertional malaise, breathlessness, muscle strength, muscle fatigue and heart-rate variability. Mediation analyses will examine whether the intervention leads to changes in psychological flexibility, fear-avoidance beliefs, damage beliefs, embarrassment-avoidance, symptom focusing, muscle strength and physical activity and whether these changes are associated with physical health outcomes. We will also conduct a nested qualitative study to explore participants' views of the intervention. Cost-effectiveness will be assessed by comparing health and social care service costs and quality of life outcomes between Balance-ACT and TAU at 20 weeks.Ethics and dissemination Ethical approval has been granted by the NHS Camberwell St Giles Research Ethics Committee (reference 23/LO/0941). The study results will be disseminated in peer-reviewed journals and presented at international conferences.Trial registration number NCT06231238.

Fatigue is a common and disabling symptom affecting up to 90

In Ghana, one in three adolescents are at risk of experiencing depression. However, access to treatment is limited due to the poor integration of mental health services into primary healthcare systems. Evidence-based interventions, especially psychological therapies and antidepressant medication, can restore health and functioning for depressed youth. Ghana currently runs a policy of free Senior High Secondary Education and aims to implement a national adolescent health policy. However, the mental health component is poorly developed. Our formative research informed the adaptation of a 6-session psychological intervention for depression, suitable for school-going youth aged 15-18 in Ghana. The aim of this study is to conduct a pilot trial of this 'African Youth in Mind' (Y-MIND) intervention, to answer questions of feasibility and acceptability before evaluating the intervention in a larger definitive trial. The Y-MIND intervention blends evidence-based problem-solving therapy with behavioural activation and psychoeducation. The intervention will be delivered by trained and supervised guidance and counselling coordinators. The study is a parallel arm cluster randomised controlled pilot trial. Six senior high schools will each be randomly allocated 2:1 to either the intervention condition or enhanced usual care (EUC). 60 adolescents aged 15 to 18 years in senior high schools who have scored have scored 10 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9) will be randomised. The feasibility, acceptability and appropriateness of the intervention will be assessed using short quantitative measures, and qualitative interviews with adolescents and guidance and counselling coordinators. Symptoms of depression will be measured at 5 months post baseline assessment. Outcomes for anxiety, fidelity to the intervention, and cost effectiveness evaluation will also be collected. This will be the first feasibility trial of a task-shifted psychological treatment (Y-MIND) for adolescents with depression delivered by Guidance and Counselling Coordinators in high schools in any African country. Clinicaltrials.gov NCT06740084.

South Africa faces a significant burden from mental, neurological, and substance-use (MNS) conditions, with a substantial treatment gap that hampers the country's progress toward universal health coverage (UHC). Despite National Health Insurance (NHI) reforms, equity in access, affordability and preparedness remain concerns. The South African Mental Health Investment Case (MHIC) was commissioned to evaluate the costs and benefits of implementing mental health interventions over a 15-year period to inform national planning and budgeting. The analysis incorporated a comprehensive stakeholder consultation process including a Delphi study for expert consensus and uses the WHO Inter-UN OneHealth Tool and Excel-based modelling to estimate health and economic benefits.The MHIC estimates substantial economic and social returns, particularly for interventions targeting common mental health conditions, with benefit to cost ratios of 4.0 and 3.6 to 1 for adult and childhood depression, 4.7 to 1 for perinatal depression and 1.5 and 0.6 to 1 for adult and childhood anxiety, respectively. The total investment needed represents approximately 11.6 % of the current health budget and aligns with recommended international norms for mental health funding. The cost of inaction is significant, unaddressed MNS conditions could cost South Africa 4 % of its GDP annually. The MHIC highlights the value of early prevention programs, including school-based interventions and targeted psychosocial support, which could avert prevalent cases and enhance productivity. By reallocating resources towards primary and community-based care, the MHIC advocates for an efficient and sustainable approach aligned with South Africa's UHC goals, emphasizing the critical need for intersectoral collaboration.

BACKGROUND:Functional cognitive disorder is an increasingly recognised subtype of functional neurological disorder for which treatment options are currently limited. We have developed a brief online group acceptance and commitment therapy (ACT)-based intervention. AIMS:To assess the feasibility of conducting a randomised controlled trial of this intervention versus treatment as usual (TAU). METHOD:The study was a parallel-group, single-blind randomised controlled trial, with participants recruited from cognitive neurology, neuropsychiatry and memory clinics in London. Participants were randomised into two groups: ACT + TAU or TAU alone. Feasibility was assessed on the basis of recruitment and retention rates, the acceptability of the intervention, and signal of efficacy on the primary outcome measure (Acceptance and Action Questionnaire II (AAQ-II)) score, although the study was not powered to demonstrate this statistically. Outcome measures were collected at baseline and at 2, 4 and 6 months post-intervention, including assessments of quality of life, memory, anxiety, depression and healthcare use. RESULTS:We randomised 44 participants, with a participation rate of 51.1% (95% CI 40.8-61.5%); 36% of referred participants declined involvement, but retention was high, with 81.8% of ACT participants attending at least four sessions, and 64.3% of ACT participants reported being 'satisfied' or 'very satisfied' compared with 0% in the TAU group. Psychological flexibility as measured using the AAQ-II showed a trend towards modest improvement in the ACT group at 6 months. Other measures (quality of life, mood, memory satisfaction) also demonstrated small to modest positive trends. CONCLUSIONS:It has proven feasible to conduct a randomised controlled trial of ACT versus TAU.

ABSTRACT Introduction Methodological and ethical arguments support the involvement of individuals with lived experience in research to reduce engagement barriers and ensure those directly affected by studies contribute to knowledge generation. However, there is limited evidence on the impact of including researchers with lived experience of serving a prison or community sentence in clinical trials. This qualitative study aimed to explore the value of involving researchers with lived experience of the criminal justice system as data collectors in the Mentalization for Offending Adult Males (MOAM), a multisite RCT conducted in the National Probation Service in England and Wales. Methods Semi‐structured interviews were conducted with 30 trial participants and 17 key stakeholders, either in person or via telephone. The interviews were transcribed verbatim and analysed thematically. Findings Five themes emerged for trial participants and 11 for key stakeholders. For some, lived experience researchers helped overcome engagement barriers by fostering common ground with participants who were serving a prison or community sentence during recruitment. Participants reported that the involvement of lived experience researchers enhanced the study by facilitating knowledge transfer in certain instances. However, their inclusion did not eliminate all barriers and, for some participants, introduced new challenges to engagement. Conclusion Forensic lived experience researchers bridged the gap by fostering trust between data collectors and participants. Future studies should ensure that lived experience researchers receive adequate clinical supervision to support their role. The adopted methodology challenged assumptions about knowledge generation and stereotypes associated with being an ex‐offender, benefiting both lived experience and traditional researchers. Patient or Public Contribution The study was developed in collaboration with User Voice (charity number: 1136047), who contributed to the study's design and conduct. The service user organisation co‐designed the interview schedule and directed the protocol for participant payments, emphasising a consistent approach to avoid tokenism and ensure equal recognition of all contributions. The dissemination plan was developed in partnership with individuals with lived experience of the criminal justice system.

BACKGROUND:Non-remission after psychological therapy for major depressive disorder is common, yet there are no established further-line treatments. In the UK National Health Service (NHS) Talking Therapies programme, about 50% of patients with depression who come to the end of the stepped care pathway do not show remission of symptoms. We aimed to investigate whether mindfulness-based cognitive therapy (MBCT) can improve clinical outcomes and whether the additional financial cost is worthwhile. METHODS:We conducted a parallel, randomised, controlled, superiority trial in three sites in the UK (Devon, London, and Sussex). Patients with current major depressive disorder whose symptoms had not reached remission (assessed as Patient Health Questionnaire-9 [PHQ-9] score ≥10) after an adequate dose of NHS Talking Therapies high-intensity therapy (≥12 sessions) were recruited from 20 NHS Talking Therapies services. Participants were allocated through remote random assignment (1:1) to MBCT plus treatment as usual or treatment as usual alone at the UK Clinical Research Collaboration-registered Exeter Clinical Trials Unit with minimisation on depression severity (PHQ-9 score <19 vs ≥19), antidepressant use at baseline (yes vs no), and recruitment site (Devon vs London vs Sussex). MBCT was delivered via videoconference and comprised an individual orientation session and eight weekly group sessions. The primary clinical outcome was reduction in depression symptomatology at 34 weeks after randomisation, using the PHQ-9. Cost-effectiveness was evaluated in terms of costs to primary, secondary, and tertiary health and social care services collected using the Adult Service Use Schedule and quality-adjusted life-years (QALYs) via health utilities derived from the EQ-5D. Primary outcome analyses were masked in the intention-to-treat population using observed data only. Lived experience experts were integral to all stages of this research. The trial was prospectively registered with ISRCTN, ISRCTN17755571. FINDINGS:Between April 20, 2021, and Jan 24, 2023, we enrolled 234 eligible participants, 166 (71%) of whom identified as women, 65 (28%) as men, one (<1%) as other, and two (1%) preferred not to say. The mean age was 42·5 years (SD 13·9). 201 (86%) of 234 participants were White. 118 participants were assigned to MBCT plus treatment as usual and 116 to treatment as usual alone, 101 and 102 of whom completed the final follow-up, respectively. At 34 weeks after randomisation, the MBCT plus treatment as usual group had significantly lower levels of depression symptomatology than the treatment as usual alone group (adjusted between-group difference -2·49, 95% CI -3·89 to -1·09; p=0·0006; Cohen's d -0·41, 95% CI -0·67 to -0·15). Utility scores were higher and costs were lower in the MBCT group (adjusted mean cost difference -£245·23, 95% CI -581·92 to 91·46; p=0·15) over the course of the study. The MBCT plus treatment as usual group had an estimated 99% chance of being cost-effective at the £20 000 per QALY threshold. Bootstrapped mean differences in costs and QALYs indicated a 91% probability of MBCT plus treatment as usual being less costly and more effective than treatment as usual alone for all values a decision maker might be willing to pay for an improvement in QALYs. We observed no trial or treatment-related serious adverse events and no other evidence of harms. INTERPRETATION:Our findings show that mindfulness-based treatment can be beneficial after non-remission from major depressive disorder following psychological, stepped care treatments. Together with evidence from previous studies of non-remission after pharmacological treatment, our findings establish MBCT, an easily scalable group-based intervention, as a further-line treatment. Implementation of MBCT for patients who continue to have major depressive disorder in routine care settings (NHS Talking Therapies and beyond) is warranted. FUNDING:UK National Institute for Health and Care Research Research for Patient Benefit programme.

The offender personality disorder (OPD) Pathway is a network of services across prison, health and community settings in England and Wales providing psychological support for high-risk people who have offended and are thought to have a personality disorder. As part of a national evaluation of the Pathway, semi-structured interviews were carried out with 36 Pathway users to determine their views about their experiences in these services; and whether and how these impacted on their psychological wellbeing. Framework analysis was used to analyze the data. Participants reported positive therapeutic relationships with staff; improved psychological wellbeing; and for some, a shift away from antisocial toward more pro-social identities. They also described a negative impact of staff turnover and uncertainty about the role of prison officers and psychologists within prison services. Pathway services are able to engage individuals who have not previously engaged with services. Constancy of staff is fundamental to the Pathway.

Background: Multiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50-80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological interventions for addressing SDs in PwMS, although integrating them into routine care poses challenges. This protocol details the trial assessing the acceptability and feasibility of an eight-session, clinicians supported integrated Psychosexual Intervention for people with Multiple Sclerosis (PIMS). Methods:This is a multicentre interventional two-arm randomized feasibility trial with a nested qualitative study to gather preliminary data about the intervention and the feasibility of conducting a full-scale trial. We aim to recruit 50 PwMS across three research sites in England’s National Health Service (NHS). Participants will be randomised to either the PIMS intervention (comprised of 8 sessions: 6 self-led and 2-facilitator led over the course of 12 weeks) or psychosexual education (one appointment with a facilitator to discuss treatment options). Feasibility will be assessed by collecting descriptive data on recruitment and retention rates and willingness to be randomised according to Consolidated Standards of Reporting Trials (CONSORT) feasibility and pilot trial guidelines. Patient reported outcomes (e.g., measures of sexual functioning and distress, psychological functioning, and quality of life) will be measured at baseline and follow up 14-weeks after randomisation. We will also use a nested qualitative study will use inductive thematic analysis to identify barriers to engagement with and delivery of the intervention, and to make appropriate modifications to PIMS.Discussion: The PIMS intervention will be the first integrated psychosexual intervention developed for people with Multiple Sclerosis in the UK. Assessing the feasibility of PIMS is an important first step to establishing future implementation and efficacy via a definitive randomised controlled trial. Trial registration: This trial is registered at ISRCTN: 12202900 https://doi.org/10.1186/ISRCTN12202900Registration date: 28th February 2023; Retrospectively registered IRAS identification: 305830NIHR award reference: NIHR202006Trial sponsorship: This trial is co-sponsored by South London and Maudsley NHS Foundation Trust and King’s College London. Contact: slam-ioppn.research@kcl.ac.ukProtocol version: 1.3, 21st February 2024

Traumatic brain injury (TBI) is a common presentation in emergency departments worldwide. Approximately 1.4 million adults present with TBI in England and Wales annually. Post-TBI depression (PTD) is a common neuropsychiatric consequence, affecting up to 50 https://www.isrctn.com/ISRCTN17518945 ).

Background People with functional disorders often receive high levels of healthcare resource use yet have poor outcomes. The health service costs and productivity losses of functional cognitive disorders (FCD) is unknown. Aims This study aims to report the cost to health services and productivity losses of FCD. Method Examination of healthcare service use and productivity losses in a sample of individuals with FCD who had attended a specialist out-patient clinic in south London. Results The findings revealed high rates of healthcare use, including frequent contact with general practitioners, psychologists and hospital services, as well as work absences. The total estimated cost of healthcare and productivity losses per individual over 6 months was £1114. Conclusions These results highlight the need for effective and efficient diagnostic pathways, targeted and effective interventions, and improved support for individuals with FCD.

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.

Informal care is a vital part of care for many people with chronic diseases in sub-Saharan Africa. Though challenging and demanding, many individuals are involved in the provision of this care. However, it is unclear what motivates people in sub-Saharan Africa to provide informal care. Therefore, this study explored the motivations to becoming informal caregivers of patients with chronic diseases in Uganda. Focus group discussions (FGDs) were conducted among 33 informal caregivers of patients with chronic diseases at Mbarara Regional Referral Hospital in Uganda. The participants were purposively sampled into one of five FGDs. Discussions were audio-recorded, transcribed verbatim and manually analysed using thematic analysis. The informal caregivers were aged 18 to 67, with 72.7

IntroductionSelf-harm is a common and escalating problem in prisons, particularly in women. Understanding and measuring the costs of self-harm allow high-quality evaluation of new interventions. Here, we describe the co-development of a new resource inventory, the Prison Data Inventory (Self-harm).MethodsAn existing forensic resource use tool, the SF-SUS, was adapted with prison staff and people with experience of being in prison.ResultsPiloting showed that the tool takes researchers approximately two hours to complete per person.DiscussionThis tool will allow use of existing prison data to improve the evidence base for reducing self-harm in prisons. In turn this will enable policy makers and commissioners to allocate resources most effectively, improving clinical outcomes.

Background Antisocial personality disorder is a major health and social problem, but scepticism about its treatability has restricted development of the evidence base for psychological treatments. Mentalisation-based treatment (MBT) tailored for antisocial personality disorder (MBT-ASPD) can address problematic behaviours by improving the ability to understand and regulate the negative effects of thoughts and feelings. This study aimed to evaluate the clinical and cost-effectiveness of MBT-ASPD compared with probation as usual in reducing aggressive behaviours from baseline to 12 months of follow-up. Methods The Mentaliziation for Offending Adult Males (MOAM) trial was a multicentre, two-group, pragmatic, assessor-masked, randomised controlled superiority trial in England and Wales. Eligible participants were male, aged 21 years or older, convicted of an offence and under National Probation Service supervision at one of 13 sites, identified through the Community Personality Disorder Pathways Service, met DSM-5 criteria for antisocial personality disorder, and scored at least 15 on the Overt Aggression Scale-Modified (OAS-M). After a three-stage screening process, consenting participants were randomly allocated (1:1), stratified by site, age, probation order type, and remaining probation duration, to either MBT-ASPD plus probation as usual, or probation as usual alone. Participants in the MBT-ASPD group were offered 12 months of weekly 75-min group therapy sessions and monthly 50 min individual sessions. Probation as usual lasted up to 12 months, after which participants continued under National Probation Service supervision for the remainder of their term. Investigators and data collectors were masked to treatment allocation. The primary outcome was aggression measured by the OAS-M at 12 months after random allocation. Data were collected by a hybrid team of traditional researchers and researchers with lived experience of the criminal justice system. The primary analysis was conducted in the intention-to-treat population using a linear mixed- effects model, adjusted for baseline at each follow-up timepoint (months 3, 6, 9, 12, 15, 18, 21, and 24). This trial is registered with ISRCTN (ISRCTN 32309003), and all pre-planned follow-ups are complete. Findings Between Jan 2, 2016, and Aug 31, 2018, 1946 individuals were referred to the study; after the screening process, 313 participants were randomly allocated (156 [50%] to probation as usual and 157 [50%] to MBT-ASPD plus probation as usual). Participants had a mean age of 342 years (SD 93); the majority of participants (247 [79%]) identified as White British, Irish, or White Other; followed by Black British (Caribbean, African, or Other; 30 [10%]) or Mixed (29 [9%]). At 12 months after random allocation, mean OAS-M scores were significantly higher in the probation as usual group (mean score 186 [SD 153]) than in the MBT-ASPD group (90 [126]), with an adjusted mean difference between groups of -735 (95% CI -1137 to -332); p<00001, with a medium-to-large effect size of 074. During the trial, seven participants died, and one presumed death occurred, all in the probation as usual group after random allocation, with none of the deaths deemed related to trial procedures. Interpretation MBT-ASPD holds promise as an effective intervention for individuals with antisocial personality disorder within a forensic population. Future research should explore these findings' generalisability and the sustainability of treatment gains.