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Background: There is uncertainty regarding how best to support patients with anorexia nervosa following inpatient or day care treatment. This study evaluated the impact of augmenting intensive treatment with a digital, guided, self-management intervention (ECHOMANTRA) for patients with anorexia nervosa and their carers. Methods: In this pragmatic multicentre randomised controlled trial and economic evaluation, patients with a diagnosis of anorexia nervosa or atypical anorexia nervosa, aged 16+ and attending one of the 31 inpatient or day-patient services in the UK were randomised with one of their carers to receive ECHOMANTRA plus treatment as usual (TAU), or TAU alone. ECHOMANTRA was hosted on a digital platform and included a workbook, recovery-oriented video-clips and online facilitated groups (patients only, carers only, joint patient-carer). Participants were randomised on a 1:1 ratio using a minimisation algorithm to stratify by site (N = 31) and severity (defined by BMI <15 and ≥ 15 kg/m2 at baseline). The primary outcome was patient depression, anxiety, and stress at 12 months. Primary and secondary outcomes were compared between trial arms on an intention-to-treat basis (ITT). This trial is registered with the ISRSTN registry, ISRCTN14644379. Findings: Between July 01, 2017 and July 20, 2020, 371 patient-carer dyads were enrolled and randomly assigned to ECHOMANTRA + TAU (N = 185) or TAU alone (N = 186). There were no significant differences between trial arms with regards to the primary outcome (completed by N = 143 patients in the TAU group, Mean = 61.7, SD = 29.4 and N = 109 patients in the ECHOMANTRA + TAU group, Mean = 58.3, SD = 26.9; estimated mean difference 0.48 points; 95% CI -5.36 to 6.33; p = 0.87). Differences on secondary outcomes were small and non-significant (standardised effect size estimates ≤0.25). Five patients died (2 from suicide and 3 from physical complications) over the course of the trial, and this was unrelated to their participation in the study. Interpretation: ECHOMANTRA added to TAU was not superior to TAU alone in reducing patient depression, anxiety, and stress symptoms. This may be explained by limited engagement with the intervention materials and changes in usual care practices since the beginning of the trial. Funding: National Institute for Health Research (NIHR), under its Health Technology Assessment Programme (HTA) Programme (Grant Reference Number 14/68/09). NIHR Maudsley Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Psychology and Neuroscience, and King's College London. NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust.
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BACKGROUND: Individual placement and support (IPS) is an evidence-based practice that helps individuals with mental illness gain and retain employment. IPS was implemented for young adults at a municipality level through a cross-sectoral collaboration between specialist mental healthcare, primary mental healthcare, and the government funded employment service (NAV). We investigated whether IPS implementation had a causal effect on employment outcomes for all young adults in receipt of a temporary health-related rehabilitation (work assessment allowance, WAA) welfare benefit, measured at the societal level compared to municipalities that did not implement IPS. METHOD: We used a difference in differences design to estimate the effects of IPS implementation on the outcome of workdays per year using longitudinal registry data. We estimate the average effect of being exposed to IPS implementation during four-years of implementation compared to ten control municipalities without IPS for all WAA recipients. RESULTS: We found a significant, positive, causal effect on societal level employment outcomes of 5.6 (p = 0.001, 95% CI 2.7-8.4) increased workdays per year per individual, equivalent to 12.7 years of increased work in the municipality where IPS was implemented compared to municipalities without IPS. Three years after initial exposure to IPS implementation individuals worked, on average, 10.5 more days per year equating to 23.8 years of increased work. CONCLUSIONS: Implementing IPS as a cross sectoral collaboration at a municipality level has a significant, positive, causal, societal impact on employment outcomes for all young adults in receipt of a temporary health-related rehabilitation welfare benefit.
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Empleos Subvencionados , Trastornos Mentales , Humanos , Masculino , Femenino , Adulto Joven , Adulto , Trastornos Mentales/rehabilitación , Rehabilitación Vocacional/métodos , Empleo/estadística & datos numéricos , Bienestar Social , Adolescente , Estudios LongitudinalesRESUMEN
Background: People experiencing mental health crises in the community often present to emergency departments and are admitted to a psychiatric hospital. Because of the demands on emergency department and inpatient care, psychiatric decision units have emerged to provide a more suitable environment for assessment and signposting to appropriate care. Objectives: The study aimed to ascertain the structure and activities of psychiatric decision units in England and to provide an evidence base for their effectiveness, costs and benefits, and optimal configuration. Design: This was a mixed-methods study comprising survey, systematic review, interrupted time series, synthetic control study, cohort study, qualitative interview study and health economic evaluation, using a critical interpretive synthesis approach. Setting: The study took place in four mental health National Health Service trusts with psychiatric decision units, and six acute hospital National Health Service trusts where emergency departments referred to psychiatric decision units in each mental health trust. Participants: Participants in the cohort study (n = 2110) were first-time referrals to psychiatric decision units for two 5-month periods from 1 October 2018 and 1 October 2019, respectively. Participants in the qualitative study were first-time referrals to psychiatric decision units recruited within 1 month of discharge (n = 39), members of psychiatric decision unit clinical teams (n = 15) and clinicians referring to psychiatric decision units (n = 19). Outcomes: Primary mental health outcome in the interrupted time series and cohort study was informal psychiatric hospital admission, and in the synthetic control any psychiatric hospital admission; primary emergency department outcome in the interrupted time series and synthetic control was mental health attendance at emergency department. Data for the interrupted time series and cohort study were extracted from electronic patient record in mental health and acute trusts; data for the synthetic control study were obtained through NHS Digital from Hospital Episode Statistics admitted patient care for psychiatric admissions and Hospital Episode Statistics Accident and Emergency for emergency department attendances. The health economic evaluation used data from all studies. Relevant databases were searched for controlled or comparison group studies of hospital-based mental health assessments permitting overnight stays of a maximum of 1 week that measured adult acute psychiatric admissions and/or mental health presentations at emergency department. Selection, data extraction and quality rating of studies were double assessed. Narrative synthesis of included studies was undertaken and meta-analyses were performed where sufficient studies reported outcomes. Results: Psychiatric decision units have the potential to reduce informal psychiatric admissions, mental health presentations and wait times at emergency department. Cost savings are largely marginal and do not offset the cost of units. First-time referrals to psychiatric decision units use more inpatient and community care and less emergency department-based liaison psychiatry in the months following the first visit. Psychiatric decision units work best when configured to reduce either informal psychiatric admissions (longer length of stay, higher staff-to-patient ratio, use of psychosocial interventions), resulting in improved quality of crisis care or demand on the emergency department (higher capacity, shorter length of stay). To function well, psychiatric decision units should be integrated into the crisis care pathway alongside a range of community-based support. Limitations: The availability and quality of data imposed limitations on the reliability of some analyses. Future work: Psychiatric decision units should not be commissioned with an expectation of short-term financial return on investment but, if appropriately configured, they can provide better quality of care for people in crisis who would not benefit from acute admission or reduce pressure on emergency department. Study registration: The systematic review was registered on the International Prospective Register of Systematic Reviews as CRD42019151043. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/49/70) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 25. See the NIHR Funding and Awards website for further award information.
People who experience mental health crises often go to a hospital emergency department and can be admitted to a psychiatric hospital. Emergency departments and psychiatric wards are not always the best environments for supporting people in a crisis. Emergency departments are overcrowded and waits can be very long; psychiatric wards are also very busy. Psychiatric decision units have been introduced to reduce pressure and improve experiences of crisis care. Psychiatric decision units are short-stay hospital-based units where people can be assessed and signposted to the most appropriate care. This study aimed to evaluate the effect of psychiatric decision units on emergency department visits, psychiatric admissions and the cost of mental health care, and to consider the best way for psychiatric decision units to be structured. We looked at research on similar units internationally and identified all psychiatric decision units in England. We evaluated the impact of psychiatric decision units four mental health NHS trusts on emergency department visits and psychiatric admissions by examining electronic patient records in the 2 years before and after units opened, and by comparing records in areas with and without psychiatric decision units using data from NHS Digital. We compared mental health services used by people in the 9 months before and after their first psychiatric decision unit stay. We interviewed people about their experiences of the psychiatric decision unit and crisis care. We also interviewed staff working on and referring people to psychiatric decision units. There were some reductions in psychiatric admissions, emergency department visits and wait times following opening of psychiatric decision units. The resulting cost savings were small and did not outweigh the costs of running psychiatric decision units. People mostly found units safe, calming and supportive, except where they were discharged too quickly. Psychiatric decision units worked best to reduce psychiatric admissions and improve quality of crisis care where stays were longer and staffing levels higher. Psychiatric decision units had more impact on emergency departments where they were larger and stays were shorter.
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Salud Mental , Medicina Estatal , Adulto , Humanos , Estudios de Cohortes , Análisis Costo-Beneficio , Vías Clínicas , Reproducibilidad de los Resultados , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. METHODS: The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders' views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. DISCUSSION: To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. TRIAL REGISTRATION: Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052.
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Distrés Psicológico , Migrantes , Adulto , Humanos , Países Bajos , Polonia , Psicoterapia/métodos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The COVID-19 pandemic has had an impact on population-wide mental health and well-being. Although people experiencing socioeconomic disadvantage may be especially vulnerable, they experience barriers in accessing mental health care. To overcome these barriers, the World Health Organization (WHO) designed two scalable psychosocial interventions, namely the web-based Doing What Matters in Times of Stress (DWM) and the face-to-face Problem Management Plus (PM+), to help people manage stressful situations. Our study aims to test the effectiveness of a stepped-care program using DWM and PM + among individuals experiencing unstable housing in France - a majority of whom are migrant or have sought asylum. METHODS: This is a randomised controlled trial to evaluate the effectiveness and cost effectiveness of a stepped-care program using DWM and PM + among persons with psychological distress and experiencing unstable housing, in comparison to enhanced care as usual (eCAU). Participants (N = 210) will be randomised to two parallel groups: eCAU or eCAU plus the stepped-care program. The main study outcomes are symptoms of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). DISCUSSION: This randomised controlled trial will contribute to a better understanding of effective community-based scalable strategies that can help address the mental health needs of persons experiencing socioeconomic disadvantage, whose needs are high yet who frequently have limited access to mental health care services. TRIAL REGISTRATION: this randomised trial has been registered at ClinicalTrials.gov under the number NCT05033210.
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COVID-19 , Salud Mental , Humanos , COVID-19/epidemiología , Vivienda , Pandemias , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Mental health expenditure accounts for just 2.1% of total domestic governmental health expenditure per capita. There is an economic, as well as moral, imperative to invest more in mental health given the long-term adverse impacts of mental disorders. This paper focuses on how economic evidence can be used to support the case for action on global mental health, focusing on refugees and people displaced due to conflict. Refugees present almost unique challenges as some policy makers may be reluctant to divert scarce resources away from the domestic population to these population groups. A rapid systematic scoping review was also undertaken to identify economic evaluations of mental health-related interventions for refugees and displaced people and to look at how this evidence base can be strengthened. Only 11 economic evaluations focused on the mental health of refugees, asylum seekers and other displaced people were identified. All but two of these intervention studies potentially could be cost-effective, but only five studies reported cost per quality-adjusted life year gained, a metric allowing the economic case for investment in refugee mental health to be compared with any other health-focused intervention. There is a need for more consistent collection of data on quality of life and the longer-term impacts of intervention. The perspective adopted in economic evaluations may also need broadening to include intersectoral benefits beyond health, as well as identifying complementary benefits to host communities. More use can be also made of modelling, drawing on existing evidence on the effectiveness and resource requirements of interventions delivered in comparable settings to expand the current evidence base. The budgetary impact of any proposed strategy should be considered; modelling could also be used to look at how implementation might be adapted to contain costs and take account of local contextual factors.
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Mental health is inextricably linked to both poverty and future life chances such as education, skills, labour market attachment and social function. Poverty can lead to poorer mental health, which reduces opportunities and increases the risk of lifetime poverty. Cash transfer programmes are one of the most common strategies to reduce poverty and now reach substantial proportions of populations living in low- and middle-income countries. Because of their rapid expansion in response to the COVID-19 pandemic, they have recently gained even more importance. Recently, there have been suggestions that these cash transfers might improve youth mental health, disrupting the cycle of disadvantage at a critical period of life. Here, we present a conceptual framework describing potential mechanisms by which cash transfer programmes could improve the mental health and life chances of young people. Furthermore, we explore how theories from behavioural economics and cognitive psychology could be used to more specifically target these mechanisms and optimise the impact of cash transfers on youth mental health and life chances. Based on this, we identify several lines of enquiry and action for future research and policy.
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BACKGROUND: Well-organised and managed workplaces can be a source of wellbeing. The construction, healthcare and information and communication technology sectors are characterised by work-related stressors (e.g. high workloads, tight deadlines) which are associated with poorer mental health and wellbeing. The MENTUPP intervention is a flexibly delivered, multi-level approach to supporting small- and medium-sized enterprises (SMEs) in creating mentally healthy workplaces. The online intervention is tailored to each sector and designed to support employees and leaders dealing with mental health difficulties (e.g. stress), clinical level anxiety and depression, and combatting mental health-related stigma. This paper presents the protocol for the cluster randomised controlled trial (cRCT) of the MENTUPP intervention in eight European countries and Australia. METHODS: Each intervention country will aim to recruit at least two SMEs in each of the three sectors. The design of the cRCT is based on the experiences of a pilot study and guided by a Theory of Change process that describes how the intervention is assumed to work. SMEs will be randomly assigned to the intervention or control conditions. The aim of the cRCT is to assess whether the MENTUPP intervention is effective in improving mental health and wellbeing (primary outcome) and reducing stigma, depression and suicidal behaviour (secondary outcome) in employees. The study will also involve a process and economic evaluation. CONCLUSIONS: At present, there is no known multi-level, tailored, flexible and accessible workplace-based intervention for the prevention of non-clinical and clinical symptoms of depression, anxiety and burnout, and the promotion of mental wellbeing. The results of this study will provide a comprehensive overview of the implementation and effectiveness of such an intervention in a variety of contexts, languages and cultures leading to the overall goal of delivering an evidence-based intervention for mental health in the workplace. TRIAL REGISTRATION: Please refer to Item 2a and registration ISRCTN14104664. Registered on 12th July 2022.
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Trastornos Mentales , Lugar de Trabajo , Humanos , Proyectos Piloto , Lugar de Trabajo/psicología , Salud Mental , Promoción de la Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Literatura de Revisión como AsuntoRESUMEN
AIMS OF THE STUDY: After arriving in host countries, most refugees are confronted with numerous post-migration stressors (e.g., separation from family, discrimination, and employment difficulties). Post-migration living difficulties (PMLDs) significantly contribute to the development and persistence of mental disorders. Effective treatment approaches focusing on reducing post-migration stress are urgently needed. The aim of the present study was to examine the effect of a brief psychological intervention, Problem Management Plus (PM+), on PMLDs among Syrian refugees in two European countries. METHODS: We merged data from two single-blind feasibility trials with Syrian refugees experiencing elevated levels of psychological distress and impaired functioning in Switzerland (N = 59) and the Netherlands (N = 60). Participants were randomised to receive either five sessions of PM+ or an enhanced care-as-usual control condition. PMLDs were assessed at baseline and 3 months after the intervention. To estimate treatment effect on PMLD, linear mixed model analysis was performed. RESULTS: Three months after the intervention, participants in the PM+ condition reported significantly fewer PMLDs compared to the control condition. Further analyses at item-level showed that interpersonal and family related PMLDs, such as "worries about family back home" significantly improved over time in the PM+ condition. CONCLUSIONS: This exploratory study suggests that brief psychological interventions have the potential to reduce PMLDs in refugees and asylum seekers. The reduction of post-migration stress in turn may subsequently lead to an overall reduction in psychological distress. CLINICAL TRIAL NUMBERS: BASEC Nr. 2017-0117 (Swiss trial) and NL61361.029.17, 7 September 2017 (Dutch trial).
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Trastornos Mentales , Refugiados , Trastornos por Estrés Postraumático , Humanos , Intervención Psicosocial , Suiza , Países Bajos/epidemiología , Método Simple Ciego , Trastornos Mentales/terapia , Refugiados/psicología , Trastornos por Estrés Postraumático/psicologíaRESUMEN
Background: Hong Kong is among the many populations that has experienced the combined impacts of social unrest and the COVID-19 pandemic. Despite concerns about further deteriorations in youth mental health globally, few epidemiological studies have been conducted to examine the prevalence and correlates of major depressive episode (MDE) and other major psychiatric disorders across periods of population-level changes using diagnostic interviews. Methods: We conducted a territory-wide household-based epidemiological study from 2019 to 2022 targeting young people aged 15-24 years. MDE, generalised anxiety disorder (GAD), panic disorder (PD), and bipolar disorder (BD) were assessed using the Composite International Diagnostic Interview-Screening Scales in 3340 young people. Psychotic disorders were assessed by experienced psychiatrists according to the DSM. Help-seeking patterns were also explored. Findings: 16.6% had any mental disorder (13.7% 12-month MDE, 2.3% BD, 2.1% GAD, 1.0% PD, 0.6% psychotic disorder). The prevalence of MDE increased from 13.2% during period 1 (May 2019-June 2020) to 18.1% during period 2 (July-December 2020), followed by 14.0% during period 3 (January-June 2021) and 13.2% during period 4 (July 2021-June 2022). Different stressors uniquely contributed to MDE across periods: social unrest-related stressors during period 1, COVID-19 stressors during period 2, and personal stressors during periods 3-4. Lower resilience, loneliness, frequent nightmares, and childhood adversity were consistently associated with MDE. Compared to other conditions, those with MDE showed the lowest service utilisation rate (16.7%). Perceiving services to "cost too much" and "talked to friends or relatives instead" were among the major reasons for not seeking help. MDE was also significantly associated with poorer functioning and health-related quality of life. Interpretation: MDE can be sensitive to population-level changes, although its persistently elevated prevalence across the study period is of concern. Efforts to mitigate their impacts on youth mental health alongside personal risk factors are needed. Further work is required to increase the availability and acceptability of youth-targeted mental health services. Funding: Food and Health Bureau (HKSAR Government).
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OBJECTIVES: More people with dementia live in low- and middle-income countries (LMICs) than in high-income countries, but best-practice care recommendations are often based on studies from high-income countries. We aimed to map the available evidence on dementia interventions in LMICs. METHODS: We systematically mapped available evidence on interventions that aimed to improve the lives of people with dementia or mild cognitive impairment (MCI) and/or their carers in LMICs (registered on PROSPERO: CRD42018106206). We included randomised controlled trials (RCTs) published between 2008 and 2018. We searched 11 electronic academic and grey literature databases (MEDLINE, EMBASE, PsycINFO, CINAHL Plus, Global Health, World Health Organization Global Index Medicus, Virtual Health Library, Cochrane CENTRAL, Social Care Online, BASE, MODEM Toolkit) and examined the number and characteristics of RCTs according to intervention type. We used the Cochrane risk of bias 2.0 tool to assess the risk of bias. RESULTS: We included 340 RCTs with 29,882 (median, 68) participants, published 2008-2018. Over two-thirds of the studies were conducted in China (n = 237, 69.7%). Ten LMICs accounted for 95.9% of included RCTs. The largest category of interventions was Traditional Chinese Medicine (n = 149, 43.8%), followed by Western medicine pharmaceuticals (n = 109, 32.1%), supplements (n = 43, 12.6%), and structured therapeutic psychosocial interventions (n = 37, 10.9%). Overall risk of bias was judged to be high for 201 RCTs (59.1%), moderate for 136 (40.0%), and low for 3 (0.9%). CONCLUSIONS: Evidence-generation on interventions for people with dementia or MCI and/or their carers in LMICs is concentrated in just a few countries, with no RCTs reported in the vast majority of LMICs. The body of evidence is skewed towards selected interventions and overall subject to high risk of bias. There is a need for a more coordinated approach to robust evidence-generation for LMICs.
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Disfunción Cognitiva , Demencia , Humanos , China , Disfunción Cognitiva/terapia , Bases de Datos Factuales , Demencia/terapia , Países en Desarrollo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: Compulsory mental health care includes compulsory hospitalisation and outpatient commitment with medication treatment without consent. Uncertain evidence of the effects of compulsory care contributes to large geographical variations and a controversy on its use. Some argue that compulsion can rarely be justified and should be reduced to an absolute minimum, while others claim compulsion can more frequently be justified. The limited evidence base has contributed to variations in care that raise issues about the quality/appropriateness of care as well as ethical concerns. To address the question whether compulsory mental health care results in superior, worse or equivalent outcomes for patients, this project will utilise registry-based longitudinal data to examine the effect of compulsory inpatient and outpatient care on multiple outcomes, including suicide and overall mortality; emergency care/injuries; crime and victimisation; and participation in the labour force and welfare dependency. METHODS: By using the natural variation in health providers' preference for compulsory care as a source of quasi-randomisation we will estimate causal effects of compulsory care on short- and long-term trajectories. CONCLUSIONS: This project will provide valuable insights for service providers and policy makers in facilitating high quality clinical care pathways for a high risk population group.
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Loneliness is increasingly viewed from a public health perspective given its association with poor physical and mental health. This includes tackling loneliness as an element of policy to promote mental health and wellbeing recovery post Covid. Facilitating participation of older people in social activities is part of the cross-governmental strategy to address loneliness in England. Such interventions have more chance of being effective if they resonate with and sustain engagement with their intended target audience. This study explored experiences of a personalized support and community response service to loneliness in Worcestershire, England. It involved interviews with 41 participants, gaining insights on routes into the program, perceived impacts, suitability and appeal. Results indicate multiple entry pathways, reaching individuals who would otherwise never have initiated engagement. Many participants felt the program promoted their confidence and self-esteem, as well as reengagement in social activities. Volunteers were pivotal to positive experiences. The program did not have universal appeal; some would have preferred a befriending service, whilst others desired opportunities to engage in intergenerational activities. Early identification and better understanding of determinants of loneliness, as well as co-creation, flexibility in form, regular feedback and volunteer support would help strengthen program appeal.
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INTRODUCTION: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. METHODS: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation. RESULTS: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries. CONCLUSIONS: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums. TRIAL REGISTRATION: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.
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Cese del Hábito de Fumar , Adulto , Humanos , Sur de Asia , Estudios de Factibilidad , Fumar , Terapia Conductista , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Evidence-based mental health interventions to support healthcare workers (HCWs) in crisis settings are scarce. OBJECTIVE: To evaluate the capacity of a mental health intervention in reducing anxiety and depression symptoms in HCWs, relative to enhanced care as usual (eCAU), amidst the COVID-19 pandemic. METHODS: We conducted an analyst-blind, parallel, multicentre, randomised controlled trial. We recruited HCWs with psychological distress from Madrid and Catalonia (Spain). The intervention arm received a stepped-care programme consisting of two WHO-developed interventions adapted for HCWs: Doing What Matters in Times of Stress (DWM) and Problem Management Plus (PM+). Each intervention lasted 5 weeks and was delivered remotely by non-specialist mental health providers. HCWs reporting psychological distress after DWM completion were invited to continue to PM+. The primary endpoint was self-reported anxiety/depression symptoms (Patient Health Questionnaire-Anxiety and Depression Scale) at week 21. FINDINGS: Between 3 November 2021 and 31 March 2022, 115 participants were randomised to stepped care and 117 to eCAU (86% women, mean age 37.5). The intervention showed a greater decrease in anxiety/depression symptoms compared with eCAU at the primary endpoint (baseline-adjusted difference 4.4, 95% CI 2.1 to 6.7; standardised effect size 0.8, 95% CI 0.4 to 1.2). No serious adverse events occurred. CONCLUSIONS: Brief stepped-care psychological interventions reduce anxiety and depression during a period of stress among HCWs. CLINICAL IMPLICATIONS: Our results can inform policies and actions to protect the mental health of HCWs during major health crises and are potentially rapidly replicable in other settings where workers are affected by global emergencies. TRIAL REGISTRATION NUMBER: NCT04980326.
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COVID-19 , Distrés Psicológico , Humanos , Femenino , Adulto , Masculino , Salud Mental , Pandemias , Personal de Salud/psicologíaRESUMEN
BACKGROUND: The COVID-19 pandemic has had major and potentially long-lasting effects on mental health and wellbeing across populations worldwide. However, these impacts were not felt equally, leading to an exacerbation of health inequalities, especially affecting vulnerable populations such as migrants, refugees and asylum seekers. Aiming to inform the adaptation and implementation of psychological intervention programmes, the present study investigated priority mental health needs in this population group. METHODS: Participants were adult asylum seekers, refugees and migrants (ARMs) and stakeholders with experience in the field of migration living in Verona, Italy, and fluent in Italian and English. A two-stage process was carried out to examine their needs using qualitative methods including free listing interviews and focus group discussions, according to Module One of the DIME (Design, Implementation, Monitoring, and Evaluation) manual. Data were analyzed using an inductive thematic analyses approach. RESULTS: A total of 19 participants (12 stakeholders, 7 ARMs) completed the free listing interviews and 20 participants (12 stakeholders and 8 ARMs) attended focus group discussions. Salient problems and functions that emerged during free listing interviews were discussed during the focus group discussions. During the COVID-19 pandemic, ARMs struggled with many everyday living difficulties in their resettlement country due to social and economic issues, revealing a strong influence of contextual factors in determining mental health. Both ARMs and stakeholders highlighted a mismatch between needs, expectations and interventions as factors that may hamper proper implementation of health and social programmes. CONCLUSIONS: The present findings could help in the adaptation and implementation of psychological interventions targeting the needs of asylum seekers, refugees and migrants aiming to find a match between needs, expectations, and the corresponding interventions. TRIAL REGISTRATION: Registration number 2021-UNVRCLE-0106707, February 11 2021.
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COVID-19 , Migrantes , Adulto , Humanos , Pandemias , COVID-19/epidemiología , Investigación Cualitativa , Accesibilidad a los Servicios de SaludRESUMEN
BACKGROUND: Loneliness is associated with many mental health conditions, as both a potential causal and an exacerbating factor. Richer evidence about how people with mental health problems experience loneliness, and about what makes it more or less severe, is needed to underpin research on strategies to help address loneliness. METHODS: Our aim was to explore experiences of loneliness, as well as what helps address it, among a diverse sample of adults living with mental health problems in the UK. We recruited purposively via online networks and community organisations, with most interviews conducted during the COVID-19 pandemic. Qualitative semi-structured interviews were conducted with 59 consenting participants face-to-face, by video call or telephone. Researchers with relevant lived experience were involved at all stages, including design, data collection, analysis and writing up of results. FINDINGS: Analysis led to identification of four overarching themes: 1. What the word "lonely" meant to participants, 2. Connections between loneliness and mental health, 3. Contributory factors to continuing loneliness, 4. Ways of reducing loneliness. Central aspects of loneliness were lack of meaningful connections with others and lack of a sense of belonging to valued groups and communities. Some drivers of loneliness, such as losses and transitions, were universal, but specific links were also made between living with mental health problems and being lonely. These included direct effects of mental health symptoms, the need to withdraw to cope with mental health problems, and impacts of stigma and poverty. CONCLUSIONS: The multiplicity of contributors to loneliness that we identified, and of potential strategies for reducing it, suggest that a variety of approaches are relevant to reducing loneliness among people with mental health problems, including peer support and supported self-help, psychological and social interventions, and strategies to facilitate change at community and societal levels. The views and experiences of adults living with mental health problems are a rich source for understanding why loneliness is frequent in this context and what may address it. Co-produced approaches to developing and testing approaches to loneliness interventions can draw on this experiential knowledge.