Colorectal cancer (CRC) is the fourth most common cancer in the UK and second leading cause of cancer-related deaths. The faecal immunochemical test (FIT) is a non-invasive home-based test used for both symptomatic assessment and population-based screening. However, approximately 30% of screening FIT kits and 10% of symptomatic FIT kits are never returned. Under-served populations, including ethnic minorities, socioeconomically deprived communities and those with mental health conditions, experience particularly low FIT return rates, contributing to health inequalities in CRC outcomes. This systematic review aims to synthesise evidence on the effectiveness and acceptability of interventions to improve FIT returns in both asymptomatic screening and symptomatic populations, with particular focus on under-served communities.

We will conduct a systematic review of qualitative and quantitative evidence. We will search Scopus, MedLine via Ovid, CINAHL via Ebsco and Cochrane Central Register of Controlled Trials from September 2010 onwards, supplemented by reference screening and trial registry searches. Eligible studies will include randomised controlled trials, quasi-experimental studies, observational studies, qualitative studies, mixed-methods studies and implementation studies examining FIT interventions in screening or symptomatic populations. Two reviewers will independently screen search results for eligible studies. Data extraction will capture study characteristics, population demographics, intervention components and outcomes including FIT return rates, acceptability, feasibility and implementation factors. Quantitative data will undergo systematic tabulation and meta-analysis where appropriate, with narrative synthesis for heterogeneous studies. Qualitative data will be analysed using framework-based thematic analysis, mapping findings to both the theoretical domains framework and theoretical framework of acceptability. A mixed-methods synthesis will integrate quantitative and qualitative findings to identify intervention characteristics, implementation strategies and contextual factors associated with improved outcomes across different population groups.

Ethics approval is not required as this systematic review will analyse published studies. Findings will be disseminated through peer-reviewed publication and conference presentations.

CRD420251111663.

A significant proportion of adults in England and Wales report experiencing childhood trauma, which is often associated with poor health and negative social outcomes including a significant increase in the risk of poor mental health outcomes in adulthood. This proposed scoping review adopts a broad definition of childhood trauma and applies both a salutogenic framework and ecological systems theory to explore how protective factors at five ecological levels can support mental well-being. The review will also examine how protective factors vary across different population groups and contexts.

The scoping review will follow the Joanna Briggs Institute (JBI) protocol for scoping reviews. The databases that will be searched are Embase, PubMed, Web of Science, PsycINFO, CINAHL and Medline. Studies will be included if they include protective factors and involve adults aged 18 and over who have experienced childhood trauma, whether self-identified, retrospectively self-reported or measured using a validated instrument. Studies will be excluded if they focus on participants under the age of 18.

All search results will be uploaded to Covidence, duplicates removed, and titles/abstracts screened by at least two reviewers based on inclusion criteria. Full texts of potentially relevant sources will be imported into EndNote 21. Reasons for exclusions will be documented and disagreements resolved through discussion or a third reviewer. The full process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted by at least two reviewers using a tool developed by the team based on the JBI guidance. A best-fit framework analysis will be used, using a matrix developed by the researchers including the four salutogenic domains and the five levels of the ecological framework.

Formal ethical approval is not necessary for this scoping review as it does not involve the collection of primary data. The outcomes of this study will be disseminated through peer-reviewed journal articles, conference/seminar presentations, and developed into resources for stakeholders and collaborators.

Open Science Framework (DOI 10.17605/OSF.IO/CJRUY).

There is a recognised need to provide equity in healthcare through inclusion of ethnic minorities in research. South Asians, the largest ethnic minority group in the UK, experience high levels of mental illness, often against the backdrop of socioeconomic deprivation and discrimination. The research community recognises that South Asian communities are often excluded from health research. Efforts have been made to understand the barriers and facilitators to their participation. However, the participation of individuals at the intersection of mental ill health and South Asian ethnicity remains understudied. This is a protocol for the synthesis of qualitative evidence from mental health research studies about participation, motivation and barriers to recruitment of South Asians in high-income countries.

We will search 10 databases for qualitative evidence on participation of South Asian individuals in mental health research studies in high-income countries: MEDLINE, EMBASE, PsycINFO, Health Management Information Consortium, Social Policy and Practice, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Social Sciences Citation Index, Science Citation Index Expanded and ProQuest Dissertations and Theses Citation Index. Search terms for the following five concepts will be used: (1) South Asia, (2) ethnic minority, (3) mental health conditions, (4) barriers and facilitators to participation and (5) high-income countries. No date restriction will be applied to the search. Searches will be limited to studies in the English language. Study selection and data extraction will be performed by two researchers independently, using Covidence. Demographic data, thematic outputs and salient discussion points will be extracted from final full-text inclusions and entered into NVivo for coding. Meta-ethnographic approaches using first and second-order constructs from included studies will be used to form third-order constructs. This synthesis will generate new knowledge regarding the intersectionality of mental health and South Asian ethnicity.

Ethical approval is not required as this study is a synthesis of published data. This review will provide new knowledge regarding the requirements for researchers and practitioners to advance the involvement of South Asian populations in mental health research. This will undoubtedly enhance equity in the long term, reduce the burden of mental disorders and enable the provision of more effective mental health care for South Asian communities.

CRD42025626382.

The objective of this study was to examine patient experiences with virtual (telephone and video) encounters in primary care and make recommendations to inform the broader adoption of virtual care.

A descriptive qualitative study using semi-structured interviews for data collection.

Ontario, Canada.

Fifty-five primary care patients across Ontario, Canada, who had experienced at least one virtual (telephone or video) encounter with a healthcare provider in primary care, participated in semi-structured individual interviews conducted between 15 January 2021 and 22 March 2021.

With respect to patients’ experiences with virtual care appointments, we identified the following seven themes: (1) Enhancing access, (2) Importance of patient-provider relationship, (3) Active communication and attunement, (4) Assuring privacy and confidentiality, (5) Shorter appointments, (6) Asynchronous technologies being underutilised and (7) Strengthening the future of virtual care. Despite the rapid adoption of synchronous virtual care, participants generally reported positive experiences. Virtual care enhanced access to care and was overwhelmingly supported for continued use. While new patient-provider relationships faced challenges, pre-existing, positive relationships thrived. Concerns about the shortness of virtual care appointments were reported.

Virtual care offers a promising modality for patients to experience care. Moving forward, primary care practices should consider expanding options for asynchronous virtual care, consider the length of virtual care appointments and offer patients greater choice in the modality of their care appointments.

Mental health and substance use problems among people released from prison contribute substantially to premature mortality and emergency services demand. Understanding of mental health and substance use-related health service contacts prior to these severe and costly outcomes is limited. We assessed mental health and substance use-related contact with multiple services, comparing rates of contact among people released from prison to a matched general population sample who had not recently been in prison.

To compare rates of health service contacts for mental health and substance use between people released from prison and a matched general population sample.

We conducted a retrospective cohort study using linked administrative data with nationwide coverage. The cohort contained all people released from any Scottish prison in 2015 (exposed group), and a random general population sample matched (ratio 1:5) on sex, age, postcode and deprivation indices, who had no imprisonment in the 5 years prior (unexposed group). We linked individual-level administrative healthcare (prescriptions, outpatient, inpatient, emergency/unscheduled care: 2010–2020), prison (admissions, releases: 2010–2020) and deaths records (2015–2020). We estimated adjusted incidence rate ratios (aIRRs) with 95% CIs using fixed-effects Poisson regression with cluster-robust standard errors, controlling for time-in-community, pre-index mental health and substance use-related health service contacts, and comorbidities. We stratified models by mental health (MH), substance use (SU) and dual diagnosis (attributable to both MH and SU).

Scotland.

We linked records for 8313 people released from prison, and 41 213 matched individuals. Mental health and substance use-related contact rates were significantly higher for people released from prison across all services, and particularly for emergency and unscheduled care. aIRRs for ambulance contacts were MH=7.75 (95% CI 5.76 to 10.42), SU=7.58 (95% CI 5.71 to 10.08), dual diagnosis=8.28 (95% CI 6.50 to 10.55); and accident and emergency department contacts were MH=4.88 (95% CI 3.78 to 6.29) and SU=7.98 (95% CI 5.71 to 11.17). aIRRs for community prescriptions were MH=1.80 (95% CI 1.67 to 1.94), SU=5.95 (95% CI 4.83 to 7.32), dual diagnosis=5.33 (95% CI 3.70 to 7.68); drug and alcohol services were 7.13 (95% CI 6.00 to 8.48); and outpatient attendances were 2.61 (95% CI 2.17 to 3.16). aIRRs for 24-hour unscheduled telephone support were MH=7.63 (95% CI 4.93 to 11.83) and SU=8.29 (95% CI 3.99 to 17.22); and out-of-hours general practice were MH=5.14 (95% CI 3.66 to 7.22), SU=5.89 (95% CI 3.11 to 11.14) and dual diagnosis=8.85 (95% CI 2.94 to 26.63). aIRRs for general/acute hospital admissions and day cases were MH=2.97 (95% CI 1.43 to 6.16), SU=7.85 (95% CI 4.42 to 13.91), dual diagnosis=13.11 (95% CI 7.95 to 21.61); and for psychiatric admissions were MH=3.62 (95% CI 2.39 to 5.49), SU=10.74 (95% CI 6.12 to 18.84) and dual diagnosis=7.74 (95% CI 4.30 to 13.94).

Improved post-release mental health and substance use care is vital for individual and public health. Despite elevated rates of contact with community mental health and substance use services, people released from prison have disproportionately high rates of contact with emergency and unscheduled care services. This suggests that early support is either inadequate or not accessed by those in greatest need.

Policymakers and service providers should consider investment in tailored transitional and post-release intervention at individual and population level, to improve health and thus prevent later high-cost service use and avoidable mortality. Our results also suggest high-quality care must be available and accessible beyond the immediate post-release period to permit sustained engagement or engagement at a later date.

Large-scale stroke registries can provide critical insights into disease mechanisms, progression and healthcare needs, informing prevention and care. However, few collect detailed demographic, brain imaging, and comprehensive long-term follow-up data. To address this, we established the prospective Stroke Investigation Group in North And central London (SIGNAL) registry in 2017.

The SIGNAL registry included 3931 adults aged ≥18 years with confirmed acute stroke (cerebral ischaemia or intracerebral haemorrhage (ICH)) admitted to the University College London Hospital hyperacute stroke unit between January 2017 and 2020, drawn from an ethnically diverse North and Central London population (~1.6 million). Baseline data included demographic, clinical, brain imaging and next-of-kin information. Six month follow-up included measures of functional status and non-motor outcomes (anxiety, depression, fatigue, sleep, pain, language, continence, social participation, cognition) via face-to-face, telephone or postal follow-up methods.

The mean age of individuals included in the SIGNAL registry was 72.1 years, and 1806 (45.9%) were female. The ethnic distribution comprised 2365 (60%) white, 649 (16.5%) black and 511 (13%) Asian. Stroke diagnoses included 3371 (85.8%) with cerebral ischaemia and 560 (14.2%) with ICH. On admission, 2240 individuals (57.0%) had a National Institutes of Health Stroke Scale score >4, indicating moderate stroke severity. At hospital discharge, the median functional outcome, measured by the modified Rankin Scale, was 3 (IQR 1–4), indicating moderate disability. At 6 months, functional outcomes measured with mRS were available for 3755 individuals (95.6%) with a median score of 1 (IQR=0–3) and non-motor outcomes were available for 3080 individuals (92.3%). The most prevalent adverse non-motor outcomes were fatigue 1756 (57%), reduced social participation 1694 (55%) and sleep disturbance 1663 (54%).

Further analyses of SIGNAL registry data will investigating associations between stroke mechanisms, subtypes and neuroimaging features and 6-month functional status, non-motor outcomes and cognitive impairment. Longer term follow-up of survivors for ~10 years is also planned.

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.

A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.

Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.

PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.

Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.

PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.

PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Australia New Zealand registration number ACTRN12624000732583.

The work of receptionists in general practice is evolving rapidly and becoming more complex due to a number of changes within primary and community care services, such as increased digitalisation. In under-served areas, these changes have been further complicated by under-resourcing and workforce challenges around staff recruitment and retention. The National Health Service (NHS) 10-year health plan is set to accelerate further significant changes. There is limited understanding about how and why these changes and workforce challenges are impacting and will impact the future work of receptionists in general practice in under-served areas.

This realist review will build on an existing programme theory related to general practitioner workforce sustainability. The review will examine what works, for whom, how and under what circumstances for receptionist work in general practice, in under-served areas. For example, how influences such as the expectations of patients (in under-served communities), poor staffing or limited career progression. Key stakeholders, including public contributors and individuals from general practice settings, will inform the realist review.

The review will be conducted using existing secondary and grey literature sources. The search strategy comprises five electronic databases: Medline, Embase, PsycINFO, CINAHL and Web of Science Core Collection (SCIE, SSCI, AHCI) with a date limit of 2015 applied to the search. The review will follow Pawson’s five steps: (1) shaping the scope of the review; (2) searching for evidence; (3) document selection and appraisal; (4) data extraction and (5) data synthesis. The findings will be reported in accordance with the Realist and Meta-narrative Evidence Synthesis Evolving Standards.

Ethical approval is not needed for secondary analysis. The findings of this review will contribute to ongoing work as part of our ‘Workforce Voices’ programme of research. They will be disseminated to policymakers, commissioners, providers of health and social care and primary care and community healthcare teams through peer-reviewed publications, members of the public, conference presentations, social media and recommendations.

To investigate vaccination coverage for influenza and COVID-19 in the SARS-CoV-2 immunity and reinfection evaluation (SIREN) study cohort of healthcare workers (HCWs) between 2020 and 2023 and explore vaccination enablers and barriers.

A mixed-methods study nested within SIREN, a multicentre prospective cohort study of HCWs across the UK. Quantitative and qualitative methods were used sequentially, using an expansion/explanation function, enabling emergent themes observed from the quantitative stage to be explored in the qualitative stage.

SIREN sites include secondary care centres and community mental health trusts in the UK.

Quantitative analysis was conducted on data from 6048 participants. Participants were representative of the HCW workforce, with the majority being women (83%) and of white ethnicity (88%). Nurses made up the largest occupational group (33%). Qualitative analysis of data from 24 participants including five focus groups (n=21) and three semistructured interviews (n=3); 82% women, 26% minority ethnic, all working age from across the UK.

Quantitative: vaccine coverage for COVID-19 and influenza vaccines by demographic with multivariable logistical regression used to assess differences. Qualitative: thematic analysis to explore reasons behind the results seen in the quantitative stage.

COVID-19 vaccination was initially high; 97% received two doses and 94% a first booster. However, coverage was reduced to 77%, for the second booster. Influenza vaccination coverage was lowest in 2020–2021 (46%), increasing to 73% in 2021–2022 and to 79% in 2022–2023. In 2022–2023, vaccination coverage was higher for influenza than for COVID-19. High vaccine coverage for both COVID-19 and influenza was observed in doctors, pharmacists and therapists. Porters, healthcare assistants and staff from minority ethnic groups had lower vaccine coverage for both COVID-19 and influenza. Four themes were identified: (1) attitudes towards vaccination changed throughout the COVID-19 pandemic; (2) HCWs used data to inform vaccination decisions; (3) poor communication in healthcare settings contributed to a reduction in vaccination; (4) there were both positive and negative impacts of the COVID-19 vaccine on influenza vaccine uptake and other vaccination programmes.

Between 2020 and 2023 in our cohort, COVID-19 vaccination coverage decreased, whereas influenza increased. Our study found attitudes to both vaccines have shifted, becoming more favourable to influenza and less to COVID-19 boosters. Barriers to COVID-19 boosters, including concerns about side effects and vaccine effectiveness, need to be addressed with improved communication on the benefits and adverse events. Future vaccination strategies should address the differences we have identified in vaccine coverage across demographics and occupational groups, including continued efforts to improve vaccine equity.

ISRCTN11041050.

Artificial intelligence (AI) in healthcare often requires large, confidential clinical datasets. However, a recent UK government survey revealed that 20–40% of the public remain sceptical of its use in health research due to concerns about data security, patient–practitioner communication and commercialisation of data. A greater understanding of public attitudes is therefore needed, particularly in the context of stroke research.

In this article, we describe the patient and public involvement work undertaken for the AI-Based-Stroke-Risk-fActor-Classification-and-Treatment (ABSTRACT) project, which aims to train AI models to predict future stroke risk from the electronic health records of 1 18 736 patients.

We aimed to evaluate the opinions of stroke/transient ischaemic attack (TIA) patients, caregivers and members of the public on the following themes: (1) the acceptability of using AI to predict stroke from electronic health records, (2) obtaining these data using an opt-out model of consent and (3) allowing access to this dataset from members both within and outside of the routine clinical care team.

A total of 83 participants were recruited via the National Health Service social media and by approaching hospital inpatients. Participants were first provided with background information on stroke, AI in medical research and ABSTRACT’s proposed data handling protocol. A mixed methods approach was then used to explore each of the above themes using online survey, semistructured focus groups and one-to-one interviews.

Nearly all participants felt that it was appropriate to use patient data to train AI models to predict stroke risk and that it was acceptable to obtain these data via an opt-out model of consent. Almost all participants also agreed that data could be shared within and outside of the routine clinical care team, provided it was General Data Protection Regulation compliant and used for medical research only.

The public and those with lived stroke/TIA experience appeared to support using deidentified medical datasets for AI-driven stroke risk prediction under an opt-out consent model. However, this is provided that the research conducted is transparent, for a clear medical purpose and adheres to strict data security measures.

There is well-established research evidence regarding the substantial health inequalities experienced by many adults with intellectual disabilities, with significant implications for their health, well-being and quality of life. Despite this evidence, many continue to die prematurely from conditions amenable to early interventions and preventative strategies. Limited knowledge, skills and confidence regarding the needs of adults with intellectual disabilities by some health professionals is evident. Reasonable adjustments can contribute positively...

Achieving physical activity recommendations for health as part of mental healthcare for adults with severe mental illness (SMI) could enhance clinical, functional and quality of life outcomes. We have co-designed a protocol to evaluate the impact of an intervention which combines High Intensity Interval Training (HIIT) and Vigorous Intermittent Lifestyle Physical Activity (VILPA) on clinical, functional and quality of life outcomes in people who have SMI.

Pragmatic clinical trial with an intervention and control arms. Participants will be recruited from two mental health services in two different cities in the same geographical area. Participants who meet the inclusion criteria (>18 years, SMI diagnosis, not at medical risk to practise vigorous physical activity, living in the community) will be included. Those from one service will be assigned to the intervention group and those from the other to the control group. The intervention will take place in the mental healthcare centre and will comprise 16 weeks of group-based HIIT, with transition to an individual lifestyle intervention VILPA over the next 12 weeks—for a total intervention period of 28 weeks. Primary outcome (clinical and functional and quality of life) measures and secondary (self-perception and device-measured fitness, physical activity and sedentary behaviour, and experience) measures will be assessed at baseline and at 16-week, 28-week and 40-week follow-ups. Group differences in change scores will be assessed using linear mixed-effects models with time, group and their interaction as fixed effects, accounting for within-subject correlations.

The study was approved by the Human Ethics Committee of the Institute for Research and Innovation in Life and Health Sciences in Central Catalonia (Spain, CEIm code: 24/007). Data will be shared following publication of results with no end date. Results will be disseminated in peer-reviewed journals and at national and international conferences and will inform the development of recovery protocols for people with SMI.

ClinicalTrials.gov NCT06338917.