Digital adaptation of the Standing up for Myself intervention in young people and adults with intellectual disabilities: the STORM feasibility study.

Background: Stigma contributes to the negative social conditions persons with intellectual disabilities are exposed to, and it needs tackling at multiple levels. Standing Up for Myself is a psychosocial group intervention designed to enable individuals with intellectual disabilities to discuss stigmatising encounters in a safe and supportive setting and to increase their self-efficacy in managing and resisting stigma. Objectives: To adapt Standing Up for Myself to make it suitable as a digital intervention; to evaluate the feasibility and acceptability of Digital Standing Up for Myself and online administration of outcome measures in a pilot; to describe usual practice in the context of the coronavirus disease 2019 pandemic to inform future evaluation. Design: Adaptation work followed by a single-arm pilot of intervention delivery. Setting and participants: Four third and education sector organisations. Individuals with mild-to-moderate intellectual disabilities, aged 16+, members of existing groups, with access to digital platforms. Intervention: Digital Standing Up for Myself intervention. Adapted from face-to-face Standing Up for Myself intervention, delivered over four weekly sessions, plus a 1-month follow-up session. Outcomes: Acceptability and feasibility of delivering Digital Standing Up for Myself and of collecting outcome and health economic measures at baseline and 3 months post baseline. Outcomes are mental well-being, self-esteem, self-efficacy in rejecting prejudice, reactions to discrimination and sense of social power. Results: Adaptation to the intervention required changes to session duration, group size and number of videos; otherwise, the content remained largely the same. Guidance was aligned with digital delivery methods and a new group member booklet was produced. Twenty-two participants provided baseline data. The intervention was started by 21 participants (four groups), all of whom were retained at 3 months. Group facilitators reported delivering the intervention as feasible and suggested some refinements. Fidelity of the intervention was good, with over 90% of key components observed as implemented by facilitators. Both facilitators and group members reported the intervention to be acceptable. Group members reported subjective benefits, including increased confidence, pride and knowing how to deal with difficult situations. Digital collection of all outcome measures was feasible and acceptable, with data completeness ≥ 95% for all measures at both time points. Finally, a picture of usual practice has been developed as an intervention comparator for a future trial. Limitations: The pilot sample was small. It remains unclear whether participants would be willing to be randomised to a treatment as usual arm or whether they could be retained for 12 months follow-up. Conclusions: The target number of groups and participants were recruited, and retention was good. It is feasible and acceptable for group facilitators with some training and supervision to deliver Digital Standing Up for Myself. Further optimisation of the intervention is warranted. Future work: To maximise the acceptability and reach of the intervention, a future trial could offer the adapted Digital Standing Up for Myself, potentially alongside the original face-to-face version of the intervention. Study registration: This study was registered as ISRCTN16056848. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/149/03) and is published in full in Public Health Research; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information.

People with intellectual disabilities (or 'learning disabilities' in United Kingdom language) are more likely to experience poor physical and mental health than the general population. Stigma (negative stereotypes, prejudice and discrimination) has been linked to lower self-esteem, quality of life, and mental and physical ill health. Efforts to empower people with intellectual disabilities themselves to challenge stigma with a view to improving well-being, health and self-esteem are lacking. In 2017, we developed Standing Up for Myself, a brief group-based programme for people with mild-to-moderate intellectual disabilities aged 16+ to address this gap. As this study got underway, face-to-face meetings were suspended due to the coronavirus disease 2019 pandemic. We used the opportunity to assess whether Standing Up for Myself could be delivered through web-based meetings. We adapted Standing Up for Myself for digital delivery, with close input from advisors with intellectual disabilities and experienced group facilitators. We then tested the digital version in charity and education settings to evaluate if Digital Standing Up for Myself could be delivered as planned and how acceptable it was to group facilitators and participants. Four groups, with a total of 22 members, signed up to try Digital Standing Up for Myself. One participant dropped out before starting Standing Up for Myself, and the other 21 continued until the end of the programme. Retention and attendance were good; participants on average attended four of the five sessions. Ninety per cent of the core programme requirements were fully delivered as detailed in the Digital Standing Up for Myself manual. Problems with technology were manageable, although facilitators found using the Standing Up for Myself Wiki platform (an online platform for storage and sharing of resources) difficult, particularly when sharing video content. Facilitators felt acceptable levels of privacy were achieved and there were no reports of undue distress. All facilitators and many group members said they would recommend Digital Standing Up for Myself to others. Group members shared how the programme benefitted them, noting increased awareness about disabilities, and for some increased confidence, pride and independence. Some had learnt how to stand up for themselves and manage difficult situations and took pride in this. Completing outcome and health cost measures via web-based meetings was acceptable and data were largely fully complete and useable.

Effects of mental health status during adolescence on primary care costs in adulthood across three British cohorts.

PURPOSE: This study examines the association between mental health problems in adolescence and general practice (GP) costs during adulthood up to age 50 in the UK. METHODS: We conducted secondary analyses of three British birth cohorts (individuals born in single weeks in 1946, 1958 and 1970). Data for the three cohorts were analysed separately. All respondents who participated in the cohort studies were included. Adolescent mental health status was assessed in each cohort using the Rutter scale (or, for one cohort, a forerunner of that scale) completed in interviews with parents and teachers when cohort members were aged around 16. Presence and severity of conduct and emotional problems were modelled as independent variables in two-part regression models in which the dependent variable was costs of GP services from data collection sweeps up to mid-adulthood. All analyses were adjusted for covariates (cognitive ability, mother's education, housing tenure, father's social class and childhood physical disability). RESULTS: Adolescent conduct and emotional problems, particularly when coexisting, were associated with relatively high GP costs in adulthood up to age 50. Associations were generally stronger in females than males. CONCLUSION: Associations between adolescent mental health problems and annual GP cost were evident decades later, to age 50, suggesting that there could be significant future savings to healthcare budgets if rates of adolescent conduct and emotional problems could be reduced. TRIAL REGISTRATION: Not applicable.

Standing up for Myself (STORM): Adapting and piloting a web-delivered psychosocial group intervention for people with intellectual disabilities.

BACKGROUND: Our STORM intervention was developed for people (16 +) with intellectual disabilities to enhance their capacity to manage and resist stigma. The current study describes the adaptation of STORM for (synchronous) on-line delivery in the context of the Covid-19 pandemic. AIMS: To adapt the manualised face-to-face STORM group intervention for delivery via web-based meeting platforms and to conduct an initial pilot study to consider its acceptability and feasibility. METHODS AND PROCEDURES: The 5-session STORM intervention was carefully adapted for online delivery. In a pilot study with four community groups (N = 22), outcome, health economics and attendance data were collected, and fidelity of delivery assessed. Focus groups with participants, and interviews with facilitators provided data on acceptability and feasibility. OUTCOMES AND RESULTS: The intervention was adapted with minimal changes to the content required. In the pilot study, 95% of participants were retained at follow-up, 91% attended at least three of the five sessions. Outcome measure completion and fidelity were excellent, and facilitators reported implementation to be feasible. The intervention was reported to be acceptable by participants. CONCLUSIONS AND IMPLICATIONS: When provided with the necessary resources and support, people with intellectual disabilities participate actively in web-delivered group interventions.

Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools-study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).

There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial ( http://www.isrctn.com/ISRCTN16386254 ), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection will now run until 2024. The key changes to the trial outlined here include clarification of the inclusion and exclusion criteria, an amended timeline reflecting changes to the recruitment period of the trial due to the COVID-19 pandemic and clarification of the data that will be included in the statistical analysis, since the second wave of the trial was disrupted due to COVID-19.Trial registration ISRCTN Registry ISRCTN16386254. Registered on 30 August 2018.

Transitions from intensive eating disorder treatment settings: qualitative investigation of the experiences and needs of adults with anorexia nervosa and their carers.

BACKGROUND: Relapse rates for individuals with anorexia nervosa after intensive hospital treatment (in-patient or full-time day care) are high. Better knowledge about the difficulties and opportunities that arise during this transition is needed to identify factors that support or hinder continued recovery upon discharge. AIMS: The aim of this study was to explore the experiences of adult patients and their chosen carers on the process of transitioning from intensive eating disorder treatment settings to the community. METHOD: Semi-structured interviews were conducted with patients with anorexia nervosa (n = 11) discharged from day or in-patient care from specialised eating disorder units across the UK, and their chosen carers (n = 20). Data were analysed with inductive thematic analysis. RESULTS: Four interrelated themes were identified for both groups. For patients, themes were continuity of care, ambivalence about continued recovery, the value of social support and a call for enhanced transition support. For carers, themes were the impact of the eating disorder on themselves and the family, perceptions of recovery and support post-discharge, the impact of previous treatment and care experiences, and desire to create a supportive transition process. CONCLUSIONS: The study provides an insight into the unique challenges that individuals with anorexia nervosa face upon leaving intensive treatment. A lack of post-discharge planning, support system and identity formation outside of anorexia nervosa were perceived as barriers to continued recovery. Patients and carers advocated for transition support that incorporates a phased, inclusive approach with accessible professional and social support in the community.

App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial.

Current treatments for binge eating disorder (BED) and bulimia nervosa (BN) only show moderate efficacy, warranting the need for novel interventions. Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT). The aim of this study was to establish the feasibility and acceptability of augmenting treatment for individuals with BN/BED with an ICT app (FoodT), which targets motor inhibition to food stimuli using a go/no-go paradigm. Eighty patients with BED/BN receiving psychological and/or pharmacological treatment were randomly allocated to a treatment-as-usual group (TAU; n = 40) or TAU augmented with the 5-min FoodT app daily (n = 40) for 4 weeks. This mixed-methods study assessed feasibility outcomes, effect sizes of clinical change, and acceptability using self-report measures. Pre-registered cut-offs for recruitment, retention, and adherence were met, with 100% of the targeted sample size (n = 80) recruited within 12 months, 85% of participants retained at 4 weeks, and 80% of the FoodT + TAU group completing ≤8 sessions. The reduction in binge eating did not differ between groups. However, moderate reductions in secondary outcomes (eating disorder psychopathology: SES = -0.57, 95% CI [-1.12, -0.03]; valuation of high energy-dense foods: SES = -0.61, 95% CI [-0.87, -0.05]) were found in the FoodT group compared to TAU. Furthermore, small greater reductions in food addiction (SES = -0.46, 95% CI [-1.14, 0.22]) and lack of premeditation (SES = -0.42, 95% CI [-0.77, -0.07]) were found in the FoodT group when compared to TAU. The focus groups revealed acceptability of FoodT. Participants discussed personal barriers (e.g. distractions) and suggested changes to the app (e.g. adding a meditation exercise). Augmenting treatment for BED/BN with a food-specific ICT app is feasible, acceptable, and may reduce clinical symptomatology with high reach and wide dissemination.

Optimising care pathways for adult anorexia nervosa. What is the evidence to guide the provision of high-quality, cost-effective services?

The aim of this paper is to consider how changes in service planning and delivery might improve the care pathways for adult anorexia nervosa. Although anorexia nervosa has a long history in Europe, its framing as a mental disorder is quite recent. The changing forms and increasing epidemiology of eating disorders has led to the expansion of specialised services. Although some services provide care over the entire clinical course, more often services are divided into those that care for children and adolescents or adults. The transition needs to be carefully managed as currently these services may have a different ethos and expectations. Services for adults have a broad range of diversity (diagnostic subtype, medical severity, comorbidity, stage of illness and psychosocial functioning) all of which impacts on prognosis. A tailored, approach to treatment planning could optimise the pathway. Facilitating early help seeking and rapid diagnosis in primary care and reducing specialised services waiting lists for assessment and treatment could be a form of secondary prevention. The use of precision models and /or continuous outcome monitoring might reduce the third of patients who require more intensive care by applying augmentation strategies. Finally, gains from intensive care might be sustained by relapse prevention interventions and community support to bridge the transition home. Together these measures might reduce the proportion of patients (currently a third) with ill health for over 20 years. For this group rehabilitation strategies may improve functioning until new treatment emerge.

Can you find the right support for children, adolescents and young adults with anorexia nervosa: Access to age-appropriate care systems in various healthcare systems.

OBJECTIVE: Anorexia nervosa (AN) often has its onset in childhood or adolescence. However, there is insufficient knowledge regarding access to and utilisation of age-specific clinical diagnostics and treatment. METHODS: A literature review covering the last 10 years was conducted to provide a narrative review of the current state of research on the detection and treatment of young patients with AN in primary and secondary care. RESULTS: Most articles were of Western European or US origin. Timely diagnosis of the eating disorder (ED) and treatment options more often depend on the structure and quality of the national health care system than on scientific evidence. Regular paediatric health check-ups and age-appropriate eating disorder services appear to facilitate early diagnosis. Age-specific treatment that also involves the carers is often associated with a higher continuity of care and a better outcome. Although many adolescents require an extension of treatment into young adulthood, individual and health care system-related obstacles in many countries prevent a smooth transition. CONCLUSION: To improve outcomes in childhood and adolescent AN, age-specific and timely diagnostic and therapeutic procedures are urgently needed.

The impact of duration of illness on treatment nonresponse and drop-out: Exploring the relevance of enduring eating disorder concept.

OBJECTIVE: There are no generally accepted definitions or markers of treatment nonresponse in eating disorders (EDs). The aim of this paper was to examine how the duration of illness and other potential prognostic markers impacted on nonresponse and drop-out from treatment across different EDs subtypes. METHODS: A total sample of 1199 consecutively treated patients with EDs, according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria, participated in this study. Kaplan-Meier curves were calculated for each ED diagnosis in which the probability of recovery was plotted against the duration of illness. RESULTS: Full remission was more likely for people with binge eating disorder (BED; 47.4%) and anorexia nervosa (AN; 43.9%) compared to bulimia nervosa (BN; 25.2%) and other specified feeding and EDs (OSFED; 23.2%). The cut-off points for the duration of the illness related with high likelihoods of poor response was 6-8 years among OSFED, 12-14 years among AN and BN and 20-21 years among BED. Other variables predicting nonresponse included dysfunctional personality traits. CONCLUSIONS: Nonresponse to treatment is associated with duration of illness which is in turn associated with poor response to previous treatment. However, there was no evidence for staging the illness using specific duration of illness criteria. Nevertheless, the shorter temporal trajectory for OSFED suggests that early interventions may be of importance for this group.

Humanistic counselling plus pastoral care as usual versus pastoral care as usual for the treatment of psychological distress in adolescents in UK state schools (ETHOS): a randomised controlled trial.

BACKGROUND: About one in seven adolescents have a mental health disorder in England, UK. School counselling is one of the most common means of trying to address such a problem. We aimed to determine the effectiveness and cost-effectiveness of school-based humanistic counselling (SBHC) for the treatment of psychological distress in young people in England, UK. METHODS: We did a two-arm, individually randomised trial in 18 secondary state-funded schools across the Greater London area of the UK. Participants were randomly assigned (1:1) using a centrally secure randomisation procedure with random permuted blocks to either SBHC plus schools' pastoral care as usual (PCAU), or PCAU alone. Participants were pupils aged 13-16 years who had moderate-to-severe levels of emotional symptoms (measured by a score of ≥5 on the Strengths and Difficulties Questionnaire Emotional Symptoms scale) and were assessed as competent to consent to participate in the trial. Participants, providers, and assessors (who initially assessed and enrolled participants) were not masked but testers (who measured outcomes) were masked to treatment allocation. The primary outcome was psychological distress at 12 weeks (Young Person's Clinical Outcomes in Routine Evaluation measure [YP-CORE]; range 0-40), analysed on an intention-to-treat basis (with missing data imputed). Costs were assessed at 24 weeks (Client Service Receipt Inventory and service logs). The trial was registered with ISRCTN, number ISRCTN10460622. FINDINGS: 329 participants were recruited between Sept 29, 2016, and Feb 8, 2018, with 167 (51%) randomly assigned to SBHC plus PCAU and 162 (49%) to PCAU. 315 (96%) of 329 participants provided data at 12 weeks and scores were imputed for 14 participants (4%). At baseline, the mean YP-CORE scores were 20·86 (SD 6·38) for the SBHC plus PCAU group and 20·98 (6·41) for the PCAU group. Mean YP-CORE scores at 12 weeks were 16·41 (SD 7·59) for the SBHC plus PCAU group and 18·34 (7·84) for the PCAU group (difference 1·87, 95% CI 0·37-3·36; p=0·015), with a small effect size (0·25, 0·03-0·47). Overall costs at 24 weeks were £995·20 (SD 769·86) per pupil for the SBHC plus PCAU group and £612·89 (1224·56) for the PCAU group (unadjusted difference £382·31, 95% CI £148·18-616·44; p=0·0015). The probability of SBHC being more cost-effective reached 80% at a willingness to pay of £390 for a 1-point improvement on the YP-CORE. Five serious adverse events occurred for four participants in the SBHC plus PCAU group, all involving suicidal intent. Two serious adverse events occurred for two participants in the PCAU group, one involving suicidal intent. INTERPRETATION: The addition of SBHC to PCAU leads to small reductions in psychological distress, but at an additional economic cost. SBHC is a viable treatment option but there is a need for equally rigorous evaluation of alternative interventions. FUNDING: This work was supported by the Economic and Social Research Council (grant reference ES/M011933/1).

Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).

BACKGROUND: There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken. METHODS AND ANALYSIS: Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3-6 months later, and 9-12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact. DISCUSSION: This trial aims to address important questions about whether schools' practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial. TRIAL REGISTRATION: ISRCTN16386254. Registered on 30 August 2018.

School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE).

INTRODUCTION: The prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools. METHOD: A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3-6 months and 9-12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact. ETHICS AND DISSEMINATION: This trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: ISRCTN17631228. PROTOCOL: V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

Equity effects of parenting interventions for child conduct problems: a pan-European individual participant data meta-analysis.

BACKGROUND: Childhood conduct problems are a costly public health problem and are five times more common in socially disadvantaged groups than they are in advantaged groups. Untreated, conduct problems have a poor prognosis, with increasing gaps between socioeconomic groups, and high rates of subsequent criminality. Incredible Years is a high quality parenting programme for reducing conduct problems and is widely disseminated in Europe. Many trials have shown Incredible Years to be effective but the potential effects of parenting interventions on social inequality are unknown. Some behavioural interventions (eg, smoking cessation programmes), although beneficial overall, can widen inequality gaps. Because single trials and aggregate-level meta-analyses are ill equipped for examining differential intervention (moderator) effects, we pooled individual-level trial data to assess the effects of Incredible Years on social equity. METHODS: We did a systematic review and individual participant data meta-analysis by searching CINAHL, Embase, Global Health, Medline, and PsycINFO, for studies published from inception to March 15, 2019. We also searched the Incredible Years website library and consulted with experts, including the European Incredible Years mentors' network. We included data from all completed randomised trials of the Incredible Years parenting intervention in Europe that included children aged 1-12 years, including unpublished trials, without restriction on publication year or outcome measures. We included prevention (selective or universal) and treatment or indicated prevention trials (for children diagnosed or above the clinical cutoff for conduct problems). We excluded trials or conditions within trials that were not randomised, included additional non-parenting material (eg, child-focused interventions), or were abbreviated, non-standard versions of the usual Incredible Years intervention of 12-14 weekly sessions. We requested individual participant data from the study authors. The primary outcome was child conduct problems, assessed using the Eyberg Child Behavior Inventory Intensity (ECBI-I) scale. Moderators were analysed using multilevel modelling with multiple imputation. FINDINGS: Of 15 European trials of Incredible Years parenting programmes (n=1696 children), individual participant data were unavailable for one trial and one trial did not assess the primary outcome. Children were aged 2-10 years (median 5·1), 492 (30%) of 1651 children were from an ethnic minority and 931 (58%) of 1614 were from low-income families. Families who received the Incredible Years intervention reported an overall reduction in child conduct problems (13·5 points on the ECBI-I scale, 95% CI 10·9-16·1). There were no differential effects by family disadvantage (indicated by poverty, lone parenthood, teenage parenthood, household joblessness, or low education), or ethnic minority status. INTERPRETATION: We found no evidence for differential effects by social disadvantage, suggesting that Incredible Years is unlikely to widen socioeconomic inequalities in conduct problems. Furthermore, the programme might be an important tool for reducing social disparities and improving poor long-term outcomes in disadvantaged families because follow-up studies indicate that benefits persist. Clinicians and commissioners can be reassured that the programme is similarly effective for families from different backgrounds. FUNDING: UK National Institute for Health Research.

Assessing the costs and cost-effectiveness of ICare internet-based interventions (protocol).

BACKGROUND: Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems. METHODS: An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service. Additionally, productivity losses will be estimated. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions, taking both a public sector and a societal perspective. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory. DISCUSSION/CONCLUSION: Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to 'treatment as usual'. The economic evaluation of ICare interventions will add considerably to this evidence base.

Web-based indicated prevention of common mental disorders in university students in four European countries - Study protocol for a randomised controlled trial.

BACKGROUND: Mental disorders and their symptoms are highly prevalent in the university student population, and the transition from secondary to tertiary education is associated with a rise in mental health problems. Existing web-based interventions for the prevention of common mental disorders in student populations often focus on just one disorder and have not been designed specifically for students. There is thus a need for transdiagnostic, student-specific preventative interventions that can be widely disseminated. This two-arm, parallel group randomised controlled trial aims to evaluate the effectiveness and cost-effectiveness of a web-based transdiagnostic mental health problem prevention programme (PLUS) across several universities in four countries. METHOD: Students (N = 5550) will be recruited through a variety of channels and asked to complete a personality assessment to determine whether they are at high risk for developing common mental disorders. Students at high risk will be randomly allocated to either PLUS or a control intervention, which provides practical support around issues commonly experienced at university. Students at low risk will be allocated to the control intervention. Both intervention groups will be assessed at baseline, 4 weeks, 3 months, 6 months and 12 months after randomisation. Depression and generalised anxiety, assessed using the Patient Health Questionnaire and the Generalised Anxiety Disorder scales, will form the primary outcomes in this study. Secondary outcome measures include alcohol and drug use, eating behaviour, self-esteem, and quality of life. The cost-effectiveness of the intervention will also be evaluated. CONCLUSIONS: This study will contribute to understanding the role of transdiagnostic indicated web-based interventions for the prevention of common mental disorders in university students. It will also be one of the first studies to investigate the cost-effectiveness of such interventions. TRIAL REGISTRATION: This trial was registered in the ISRCTN register (ISRCTN15570935) on 12th February 2016.

A web-based intervention for carers of individuals with anorexia nervosa (We Can): Trial protocol of a randomised controlled trial investigating the effectiveness of different levels of support.

BACKGROUND: Anorexia nervosa (AN) is a life-threatening mental disorder that is associated with substantial caregiver burden. Carers of individuals with AN report high levels of distress and self-blame, and insufficient knowledge to help their loved ones. However, carers can have a very important role to play in aiding recovery from AN, and are often highly motivated to assist in the treatment process. This manuscript presents the protocol for a randomised controlled trial (RCT) of We Can, a web-based intervention for carers for people with AN. The study aims to investigate the effectiveness of We Can delivered with different intensities of support. METHODS: The study takes the form of a multi-site, two-country, three group RCT, comparing We Can (a) with clinician messaging support (We Can-Ind), (b) with moderated carer chatroom support (We Can-Chat) and (c) with online forum only (We Can-Forum). Participants will be 303 carers of individuals with AN as well as, where possible, the individuals with AN themselves. Recruitment will be via specialist eating disorder services and carer support services in the UK and Germany. Randomisation of carers to one of the three intervention conditions in a 1:1:1 ratio will be stratified by whether or not the individual with AN has (a) agreed to participate in the study and (b) is a current inpatient. The We Can intervention will be provided to carers online over a period of 12 weeks. Participants will complete self-report questionnaires at pre-intervention (T1), mid-intervention (mediators only; 4-weeks post-randomisation), post-intervention (T2; 3-months post randomisation), and 6 months (T3) and 12 months (T4) after randomisation. The primary outcome variables are carer symptoms of depression and anxiety. Secondary outcome variables will be measured in both carers and individuals with AN. Secondary carer outcome variables will include alcohol and drug use and quality of life, caregiving behaviour, and the acceptability and use of We Can and associated supports. Secondary outcomes measured in individuals with AN will include eating disorder symptoms, and symptoms of depression and anxiety. The study will also evaluate the cost-effectiveness of the three We Can conditions, and test for mediators and moderators of the effects of We Can. The trial is registered at the International Standard Randomisation Controlled Trial Number (ISRCTN) database, registration number: ISRCTN11399850. DISCUSSION: The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery.

Research Review: Harnessing the power of individual participant data in a meta-analysis of the benefits and harms of the Incredible Years parenting program.

BACKGROUND: Parenting programs aim to reduce children's conduct problems through improvement of family dynamics. To date, research on the precise benefits and possible harms of parenting programs on family well-being has been unsystematic and likely to be subject to selective outcome reporting and publication bias. Better understanding of program benefits and harms requires full disclosure by researchers of all included measures, and large enough numbers of participants to be able to detect small effects and estimate them precisely. METHODS: We obtained individual participant data for 14 of 15 randomized controlled trials on the Incredible Years parenting program in Europe (total N = 1,799). We used multilevel modeling to estimate program effects on 13 parent-reported outcomes, including parenting practices, children's mental health, and parental mental health. RESULTS: Parental use of praise, corporal punishment, threats, and shouting improved, while parental use of tangible rewards, monitoring, or laxness did not. Children's conduct problems and attention deficit hyperactivity disorder (ADHD) symptoms improved, while emotional problems did not. Parental mental health (depressive symptoms, self-efficacy, and stress) did not improve. There was no evidence of harmful effects. CONCLUSIONS: The Incredible Years parenting program improves the aspects of family well-being that it is primarily designed to improve: parenting and children's conduct problems. It also improves parent-reported ADHD symptoms in children. Wider benefits are limited: the program does not improve children's emotional problems or parental mental health. There are no signs of harm on any of the target outcomes.

Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

OBJECTIVE: This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. METHODS: Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. RESULTS: There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. DISCUSSION: Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800).

Circles of Support and personalization: Exploring the economic case.

Circles of Support aim to enable people with learning disabilities (and others) to live full lives as part of their communities. As part of a wider study of the economic case for community capacity building conducted from 2012 to 2014, we conducted a mixed methods study of five Circles in North West England. Members of these Circles were supporting adults with moderate to profound learning disabilities and provided accounts of success in enabling the core member to live more independent lives with improved social care outcomes within cost envelopes that appeared to be less than more traditional types of support. The Circles also reported success in harnessing community resources to promote social inclusion and improve well-being. This very small-scale study can only offer tentative evidence but does appear to justify more rigorous research into the potential of Circles to secure cost-effective means of providing support to people with learning disabilities than the alternative, which in most cases would have been a long-term residential care placement.

Early intervention for depression and anxiety in 16-18-year-olds: Protocol for a feasibility cluster randomised controlled trial of open-access psychological workshops in schools (DISCOVER).

Adolescence is a vulnerable period for the development of mental health problems. The DISCOVER intervention aims to provide accessible, acceptable and cost-effective psychological support for stressed adolescents in inner-city secondary schools. The intervention uses age-appropriate cognitive-behavioural therapy (CBT) methods and materials, delivered in an interactive 1-day workshop with additional telephone support. An open-access entry route allows students to self-refer. This protocol describes a feasibility cluster randomised controlled trial (RCT) comparing DISCOVER with a waitlist control condition. The study will run across 10 clusters (secondary schools) in the inner London Boroughs of Southwark and Lambeth. Participants are students aged over 16years who are seeking help with anxiety and/or depressive symptoms. Key feasibility parameters relate to the proportion of students willing to participate in the research following publicity events; the proportion of students who complete the intervention; and response rates for outcome measures. Outcome variance estimates and intra-cluster correlations will be obtained for future power calculations. Qualitative methods will be used to explore the acceptability of the intervention and research procedures for students and school staff. The feasibility of an economic evaluation will also be examined. The results will (i) determine the appropriateness of proceeding to a definitive full-scale trial; and (ii) inform the development of an optimised version of the DISCOVER intervention that can be tested within feasible parameters.