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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/.

Background: type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. Objective: we combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. Methods: the development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. Results: upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. Conclusions: the intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial.

This is a cross-sectional study into the effect of primary schools on the mental health of pupils. Socioeconomic status, ethnicity, and other individual characteristics are associated with mental health outcomes in children and adolescents.[1] Given that schools serve different communities and pupil characteristics vary across schools, it is likely that the average mental health of pupils also varies by school. A small number of studies have already investigated this relationship, and found that a small proportion of variation in mental health or wellbeing is explained at school-level, after adjustment for pupil characteristics. A cross-sectional study of 23,215 year 4 & 5 pupils in 648 primary schools in England found that 4.3% of variation in "high mental health difficulties" (measured using the "Me and My Feelings" self-report questionnaire) was accounted for by schools.[2] Three longitudinal studies of secondary school pupils in England found that 1.4% of variation in mental and emotional health (measured using the "Strengths and Difficulties Questionnaire" and the "Me and My School" questionnaire) was explained at school level.[3] A cross-sectional study of 26,855 pupils at 85 secondary schools in the UK found that schools accounted for 2.4% of variation in ‘psychopathology’ (measured using the "Strengths and Difficulties Questionnaire"); 1.6% of variation in depression (measuring using "CES-D"), and 1.4% of wellbeing (measured using "WEMWEBS").[4] A small number of studies from other countries also suggest that schools account for a small but significant proportion of variation in mental health outcomes. For example, in a cross-sectional analysis of 87,341 secondary school pupils in Finland, schools accounted for 1% of variation in subjective wellbeing.[5] There are many more studies into other contextual and social determinants of young people's mental health. For example, a systematic review of parental factors associated with depression and anxiety in young people identified 181 studies.[6] This study aims to add to evidence of the contribution of schools to pupil's mental health. It also aims to include analysis of crude variation in mental health across schools (ie. whether mental varies before adjusting for pupil characteristics), which could inform prioritisation of school-level interventions to improve pupils' mental health. References: 1. Reiss F. Socioeconomic inequalities and mental health problems in children and adolescents: A systematic review. Soc Sci Med. 2013;90: 24–31. doi:10.1016/j.socscimed.2013.04.026 2. Patalay P, O’Neill E, Deighton J, Fink E. School characteristics and children's mental health: A linked survey-administrative data study. Preventative Medicine. 2020;141; 106292. doi:10.1016/j.ypmed.2020.106292 3. Hale DR, Patalay P, Fitzgerald-Yau N, Hargreaves DS, Bond L, Görzig A, et al. School-Level Variation in Health Outcomes in Adolescence: Analysis of Three Longitudinal Studies in England. Prev Sci. 2014;15: 600–610. doi:10.1007/s11121-013-0414-6 4. Ford T et al. The Role of Schools in Early Adolescents’ Mental Health: Findings From the MYRIAD Study. 2021. J Am Ac Ch Ad Psychiatry. 60,12. 1467-1478.. Doi: 10.1016/j.jaac.2021.02.016 5. Konu AI, Lintonen TP, Autio VJ. Evaluation of Well-Being in Schools ? A Multilevel Analysis of General Subjective Well-Being. Sch Eff Sch Improv. 2002;13: 187–200. doi:10.1076/sesi.13.2.187.3432 6. Yap, M.B., Pilkington, P.D., Ryan, S.M., Jorm, A.F., 2014. Parental factors associated with depression and anxiety in young people: a systematic review and meta-analysis. J. Affect. Disord. 156, 8–23. https://doi.org/10.1016/j.jad.2013.11.007. T. Fukuzaki and S. Takeda

Six months after OWLS was initiated we launched a follow-up to examine the long-term effect of some of the factors examined in OWLS 1, as well as to collect additional information to complement the data collected in the first phase.

The OWLS project is based in University of York and began in April 2020 when a group of researchers who are investigating how to improve the physical health of people with severe mental ill health wanted to explore how the pandemic restrictions were affecting people with severe mental ill health. The researchers worked together with a group of people with lived experience to come up with a series of questions to ask people that would best capture their experiences and concerns. OWLS explored the following domains: - Mental and Physical Health - Service Use - Health behaviours - COVID-19 - Social support -Digital engagement - Employment

The role of animal ownership in severe mental illness for wellbeing and loneliness during the COVID-19 pandemic: Findings from a UK survey study.

A study protocol for the use of individual participant data from randomised controlled trials