BackgroundPeople of Black African and Black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of White European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programs has the potential to improve healthcare engagement and clinical outcomes for ethnic minority groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed, culturally tailored group-based DSMES program for adults of Black African and Black Caribbean ethnicity. ObjectiveThis trial aims to evaluate the clinical and cost effectiveness of the HEAL-D intervention, compared to standard DSMES programs, in Black African and Black Caribbean adults living with T2D. MethodsA 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA1c]) assessment at 12 months. Black African and Black Caribbean adults with T2D (n=300), recruited from 3 to 5 centers in the United Kingdom (including London, West Midlands, and Greater Manchester), will be randomized in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES program (control). HbA1c, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient-reported outcome measures relating to psychological well-being and self-management support, lifestyle behaviors, and health economics will be collected at baseline and follow-up visits (6, 12, and 24 months). Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity, and implementation of HEAL-D, and an embedded study within a project will assess the impact of multiple long-term conditions on uptake of, and engagement with HEAL-D, and the impact of HEAL-D on multiple long-term conditions. The trial received Research Authority and Research Ethics Council approval on April 22, 2024. ResultsFunding began in August 2023. Site “green light” was received on August 15, 2024, for London; November 29, 2024, for Manchester; and January 31, 2025, for the West Midlands. Recruitment commenced in August 2024 and is due to run for 11 months. As of March 26, 2025, a total of 76 participants have consented. Last patient, last visit is expected in June 2027; primary data analysis is expected to begin in July 2027. Final results are anticipated to be available in September 2027, and publication is expected by the end of 2027. ConclusionsThe HEAL-D trial will address whether a culturally tailored DSMES program, provided in-person or via videoconferencing, is clinically and cost-effective compared to standard DSMES at improving diabetes management in Black African and Black Caribbean adults. If effective, this would provide an evidence-based model of equitable DSMES services and improve the implementation of healthcare programs for ethnic minority groups. Trial RegistrationISRCTN 1434448; https://www.isrctn.com/ISRCTN14344948 International Registered Report Identifier (IRRID)DERR1-10.2196/71861

Background Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs. Objective To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event. Design Multicentre pragmatic randomised controlled non-inferiority trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance. Setting Primary and secondary mental health settings across the United Kingdom's National Health Service. Participants One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation. Interventions Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60-90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions. Main outcome measures Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment. Results Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI -∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval -∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years -0.04 (95% confidence interval -0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified. Limitations The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event. Conclusions Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition. Future work Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale. Trial registration This trial is registered as ISRCTN13697710. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97) and is published in full in Health Technology Assessment; Vol. 27, No. 26. See the NIHR Funding and Awards website for further award information.

Abstract Objective To determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event. Design Pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). Setting Primary and secondary mental health settings across the UK’s NHS. Participants 196 adults with a primary diagnosis of mild to moderate PTSD were randomised in a 1:1 ratio to one of two interventions, with 82% retention at 16 weeks and 71% retention at 52 weeks. 19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process. Interventions Up to 12 face-to-face, manual based, individual CBT-TF sessions, each lasting 60-90 minutes; or guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions. Main outcome measures Primary outcome was the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation (diagnosis of PTSD based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5). Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation. Results Non-inferiority was found at the primary endpoint of 16 weeks on the CAPS-5 (mean difference 1.01, one sided 95% confidence interval −∞ to 3.90, non-inferiority P=0.012). Improvements in CAPS-5 score of more than 60% in the two groups were maintained at 52 weeks, but the non-inferiority results were inconclusive in favour of face-to-face CBT-TF at this time point (3.20, −∞ to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants. The main themes of the qualitative analysis were facilitators and barriers to engagement with guided internet based CBT-TF, treatment outcomes, and considerations for its future implementation. Conclusions Guided internet based CBT-TF for mild to moderate PTSD to one traumatic event was non-inferior to individual face-to-face CBT-TF and should be considered a first line treatment for people with this condition. Trial registration ISRCTN13697710.

Mental illnesses are the leading cause of disease burden among children and young people (CYP) globally. Low- and middle-income countries (LMIC) are disproportionately affected. Enhancing mental health literacy (MHL) is one way to combat low levels of help-seeking and effective treatment receipt. We aimed to synthesis evidence about knowledge, beliefs and attitudes of CYP in LMICs about mental illnesses, their treatments and outcomes, evaluating factors that can enhance or impede help-seeking to inform context-specific and developmentally appropriate understandings of MHL. Eight bibliographic databases were searched from inception to July 2020: PsycInfo, EMBASE, Medline (OVID), Scopus, ASSIA (ProQuest), SSCI, SCI (Web of Science) CINAHL PLUS, Social Sciences full text (EBSCO). 58 papers (41 quantitative, 13 qualitative, 4 mixed methods) representing 52 separate studies comprising 36,429 participants with a mean age of 15.3 [10.4–17.4], were appraised and synthesized using narrative synthesis methods. Low levels of recognition and knowledge about mental health problems and illnesses, pervasive levels of stigma and low confidence in professional healthcare services, even when considered a valid treatment option were dominant themes. CYP cited the value of traditional healers and social networks for seeking help. Several important areas were under-researched including the link between specific stigma types and active help-seeking and research is needed to understand more fully the interplay between knowledge, beliefs and attitudes across varied cultural settings. Greater exploration of social networks and the value of collaboration with traditional healers is consistent with promising, yet understudied, areas of community-based MHL interventions combining education and social contact.

Abstract Background Mental illnesses are the leading causes of global disease burden. The impact is heightened in low‐ and middle‐income countries (LMICs) due to embryonic care systems and extant barriers to healthcare access. Understanding children and adolescents' conceptualisations of mental health wellbeing in these settings is important to optimize health prevention and promotion initiatives. Objective To systematically review and synthesize children and adolescents' conceptualisations and views of mental health and wellbeing in LMICs. Design Ten databases were systematically searched from inception to July 2020 and findings from included studies were synthesized. Results Twenty papers met eligibility criteria comprising qualitative, quantitative and mixed methods studies. Children and adolescents identified aspects of mental health and wellbeing, including positive affect and outlook and having sufficient personal resources to face daily challenges. Identified factors recognized the importance of activating both kin and lay networks in supporting and maintaining wellbeing. Conceptualisations of mental health and wellbeing were varied and influenced by culture, developmental stage and gender. Discussion and Conclusions Irrespective of environmental and sociocultural influences on concepts of wellbeing and mental health, children and adolescents in LMICs can conceptualise these constructs and identify how they pursue positive mental health and wellbeing important for developing age and culture‐appropriate community mental health strategies. Our review highlights the need to extend inquiry to wider developmental stages and both across and within specific populations in LMICs. Patient and Public Involvement Initial results were presented at stakeholder workshops, which included children, adolescents, parents and health professionals held in Indonesia in January 2019 to allow the opportunity for feedback.

Purpose The relationship between social networks and health and wellbeing is increasingly demonstrated in vulnerable adult populations. This relationship for vulnerable children and young people has not hitherto been systematically reviewed. This narrative synthesis aims to consolidate research to provide a foundational basis for future health-related social network research and interventions for children and young people. Methods This mixed methods systematic review synthesises research investigating whole, egocentric social networks of 32 vulnerable child groups with a mean age below 18. There were no setting, language or date restrictions. The quality was assessed using the Mixed Methods Appraisal Tool. Of 6360 search results, 49 were included for narrative synthesis. Results The majority of pertinent research originates from the USA; the most frequently investigated vulnerabilities were minority ethnic status, homelessness and the presence of special educational needs. Research aims and methodologies varied significantly between studies. Key findings included (i) vulnerable (excluding minority ethnic) children and young people have impoverished networks (ii) access to networks is a protective factor against negative outcomes (iii) social ties, primarily immediate family, provide access to personal resources and (iv) network ties are to a degree substitutable. Conclusions Networks are associated with wellbeing and vulnerable children and young people commonly have impoverished networks, excluding cases where vulnerability classification relates to minority ethnic status. Network embeddedness is associated with positive outcomes, particularly for homeless children. Family are typically primary providers of support, but ties are substitutable when networks are restricted. Egocentric social network research is currently limited for vulnerable child populations. Further research could inform interventions that harness networks to improve health, wellbeing and functional outcomes for these child groups.

Public engagement events are an important early strategy in developing a meaningful research agenda, which is more impactful and beneficial to the population. Evidence indicates the potential of such activities to promote mental health literacy. However, this has not yet been explored in Indonesia. This paper describes a mental health public engagement festival carried out in Indonesia in November 2018 and uses evaluation data to consider the acceptability and use of such activities in Indonesia in the future. Evaluation data was collected from 324 of the 737 people who attended a six-day mental health festival comprising 18 events including public lectures, film screenings, arts activities, exercise classes and panel discussions. Attendees were asked to evaluate the festival in terms of its quality, benefits and areas for improvement. Descriptive statistics were used to analyse the evaluation data. 87 service users, carers, academics and professionals also engaged in a research prioritisation exercise to collaboratively determine mental health research priorities for Indonesia. Participants evaluated the festival extremely positively with a significant majority (92%) rating the quality of the festival as good or excellent. Attendees reported an increase in their understanding of mental health issues and identified intended behaviour change including an increased propensity for future engagement with mental health research. Key strengths of the festival included the central role of patients, carers and the local community in the design and delivery of the festival which promoted emotional engagement and development of shared understanding and the use of international experts which in attendees’ opinion further enhanced the credibility of festival activities. This manuscript indicates that a co-produced mental health public engagement festival is a potentially acceptable way to increase awareness of mental health in Indonesian populations. Future festivals should be larger in scope and target men, older people and the general public to maximise benefit and incorporate rigorous evaluation of effectiveness.

Introduction: Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. Despite overwhelming evidence for strength/balance training, adherence to both group and home-exercise programmes is often poor1. A novel approach is the use of home-based, strength and balance video-games (EXERGAMES) but data from randomized controlled trials are limited2. The aim of this study was to test whether a 12 week EXERGAMES home-based intervention, co-developed with older adults and therapists, can improve the risk of falling [by Berg Balance Scale (BBS)] in older adults living in sheltered housing. Methods: We conducted a two-site (Manchester/Glasgow) cluster RCT. Twelve sheltered housing facilities were randomised (1:1) to either a 12wk standard care plus 3 times/ week EXERGAMES physiotherapist one-to-one intervention (n=56) or standard care (control group n=50). Standard care involved the provision of a home exercise booklet (standard approach for those unable/unwilling to attend group exercise programmes in the community). Results: A total of 106 older adults (83F, 23M) with a mean age of 77.8y (SD 10.2; range 55-101y), were recruited for the study. A total of 91 (86%) participants completed all study visits. Over 12 weeks the EXERGAMES intervention had a significant positive impact on BBS [p=0.003; mean (SD), 44.6 (10.7) (EXERGAMES) vs. 37.6 (14.9) (Control)]. The mean change of BBS from baseline was 2.9 (8.5) for the EXERGAMES and -2.8 (6.5) for the control group. The estimated increase in BBS score due to EXERGAMES was 6.2 (95% CI 2.4 to 9.9) which is greater than the minimal detectable change for the scale of 4.93. Conclusions: Balance, and thus risk of falling, can be improved through a 12wk physiotherapy led EXERGAMES programme. This type of home based intervention could be considered as an effective alternative to traditional falls prevention exercise regimes to support outcomes for patients.

Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. The use of Exergames (active, gamified video-based exercises) is a possible innovative, community-based approach. This study aimed to determine the effectiveness of a tailored OTAGO/FaME-based strength and balance Exergame programme for improving balance, maintaining function and reducing falls risk in older people. A two-arm cluster randomised controlled trial recruiting adults aged 55 years and older living in 18 assisted living (sheltered housing) facilities (clusters) in the UK. Standard care (physiotherapy advice and leaflet) was compared to a tailored 12-week strength and balance Exergame programme, supported by physiotherapists or trained assistants. Complete case analysis (intention-to-treat) was used to compare the Berg Balance Scale (BBS) at baseline and at 12 weeks. Secondary outcomes included fear of falling, mobility, fall risk, pain, mood, fatigue, cognition, healthcare utilisation and health-related quality of life, and self-reported physical activity and falls. Eighteen clusters were randomised (9 to each arm) with 56 participants allocated to the intervention and 50 to the control (78% female, mean age 78 years). Fourteen participants withdrew over the 12 weeks (both arms), mainly for ill health. There was an adjusted mean improvement in balance (BBS) of 6.2 (95% CI 2.4 to 10.0) and reduced fear of falling (p = 0.007) and pain (p = 0.02) in the Exergame group. Mean attendance at sessions was 69% (mean exercising time of 33 min/week). Twenty-four percent of the control group and 20% of the Exergame group fell over the trial period. The change in fall rates significantly favoured the intervention (incident rate ratio 0.31 (95% CI 0.16 to 0.62, p = 0.001)). The point estimate of the incremental cost-effectiveness ratio (ICER) was £15,209.80 per quality-adjusted life year (QALY). Using 10,000 bootstrap replications, at the lower bound of the NICE threshold of £20,000 per QALY, there was a 61% probability of Exergames being cost-effective, rising to 73% at the upper bound of £30,000 per QALY. Exergames, as delivered in this trial, improve balance, pain and fear of falling and are a cost-effective fall prevention strategy in assisted living facilities for people aged 55 years or older. The trial was registered at ClinicalTrials.gov on 18 Dec 2015 with reference number NCT02634736 .

BackgroundDespite policy and practice mandates for patient involvement, people with serious mental illness often feel marginalised in decisions about antipsychotic medication.AimsTo examine stakeholder perspectives of barriers and facilitators to involving people with serious mental illness in antipsychotic prescribing decisions.MethodSystematic thematic synthesis.ResultsSynthesis of 29 studies identified the following key influences on involvement: patient's capability, desire and expectation for involvement, organisational context, and the consultation setting and processes.ConclusionsOptimal patient involvement in antipsychotic decisions demands that individual and contextual barriers are addressed. There was divergence in perceived barriers to involvement identified by patients and prescribers. For example, patients felt that lack of time in consultations was a barrier to involvement, something seldom raised by prescribers, who identified organisational barriers. Patients must understand their rights to involvement and the value of their expertise. Organisational initiatives should mandate prescriber responsibility to overcome barriers to involvement.Declaration of interestNone.

BACKGROUND:The Massachusetts Youth Screening Instrument - version 2 (MAYSI-2) is designed to assist in identifying the mental health needs of young people admitted to secure establishments. To date, very few studies have assessed the MAYSI-2 outside the USA.AIMS:This study aimed to assess the validity and clinical utility of the MAYSI-2 in England.METHODS:Boys newly admitted into one large young offenders' institution, were consecutively interviewed individually and completed the MAYSI-2, the Youth Self Report (YSR), which capture similar syndrome scales - and the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), which allows for making psychiatric diagnoses.RESULTS:Two hundred and six boys, of average age 16.5 years, completed all assessments. According to the K-SADS, co-morbidity of psychiatric disorders was high (80% of the sample). The MAYSI-2 showed good convergent validity but poorer discriminant validity with the YSR. The MAYSI-2 and YSR corresponded with both conceptually and non-conceptually relevant diagnostic domains.CONCLUSIONS:The poor ability of the MAYSI-2 and YSR to discriminate and specify disorders is likely to reflect the high rates of co-morbidity. The fact that 90% of the participants reached the caution cut-off for any scale on the MAYSI-2, while suggesting its limited use as a screening tool for this sample, is probably best reflective of the high levels of psychopathology of incarcerated young people in England and Wales since particular efforts to divert as many as possible from custody. A more holistic and comprehensive approach to assessing health needs on admission into custody may be necessary for such a population.

Objective: To investigate changes in mental health and other needs, as well as clinical and diagnostic 'caseness', in a sample of adolescents over a 6-month period following entry into a Young Offenders Institution in the UK.Design: Prospective cohort study.Setting: One Young Offenders Institution between November 2006 and August 2009.Participants: 219 male adolescents aged 15-18 years (M=16.56; SD=0.6) were assessed at baseline (median=4; range 0-26 days following reception into custody) on the Salford Needs Assessment Schedule for Adolescents (SNASA) and Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS). Participants were then reassessed at 3-month and 6-month postbaseline to document any change in mental health.Results: Of the initial baseline sample, 132 were still in the study at 3-month postbaseline and 63 were still available for assessment at 6 months. There were no differences between those who were not available for assessment at the three key stages in terms of demographic and criminological data. Over time there was a general improvement in mental health. While the proportion of participants with a mental health need (SNASA) did not change over time, symptom severity as measured by the SNASA did reduce significantly. When we assessed diagnostic 'caseness' using the K-SADS, three young people showed significant mental health deterioration.Conclusions: In line with previous studies, we found that symptoms in prison generally improved over time. Prison may provide an opportunity for young people previously leading chaotic lifestyles to settle into a stable routine and engage with services; however, it is unclear if these would be maintained either within the prison or on release into the community.