Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.

The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.

The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.

NCT06997107.

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

NCT05338944.

With the rapid increase in the ageing population, the use of procedural sedation and analgesia (PSA) for diagnostic procedures such as prostate biopsy in older adults is increasing. However, elderly patients are particularly susceptible to respiratory depression during PSA testing and have a significantly higher risk of hypoxaemia during procedures requiring deep sedation. Although propofol combined with fentanyl is commonly used, it frequently causes hypoxaemia and apnoea. Remimazolam, a novel ultrashort-acting benzodiazepine, may be a safer alternative with less respiratory compromise; however, the supporting evidence remains limited. This study aims to assess whether remimazolam combined with fentanyl reduces the incidence of respiratory depression compared with propofol combined with fentanyl in elderly patients undergoing prostate biopsy under deep sedation requiring immobility.

This is a single-centre, participant and assessor-blinded (with pragmatic blinding of participants), parallel-group, superiority randomised controlled trial conducted at the Jichi Medical University Saitama Medical Centre, Japan. Eligible participants are men aged ≥70 years who are scheduled to undergo prostate biopsy under intravenous sedation. Participants will be randomised in a 1:1 ratio to receive either remimazolam or propofol, each administered in combination with fentanyl at a fixed effect-site concentration. The primary outcome is the incidence of severe apnoea (≥1 min). The primary analysis will follow the intention-to-treat principle, implemented practically as a full analysis set analysed using a complete case approach. Sensitivity analyses will include a per-protocol analysis and multiple imputations of missing data. A subgroup analysis of patients aged ≥75 years was performed.

This study was approved by the Jichi Medical University Central Clinical Research Ethics Committee (approval number: 24JMU001S-2) and was registered with the Japan Registry of Clinical Trials on 11 November 2024. Written informed consent was obtained from all participants before enrolment. These findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

jRCTs031240478.

Depressed mood is a psychological state characterised by sadness or loss of interest in activities, is a common symptom that accompanies most major mental disorders. It is therefore reasonable to consider it as a transdiagnostic target, which when addressed, may improve the functioning and quality of life of persons with lived experience of mental disorders. However, there is limited understanding of the depressed mood as a transdiagnostic target across major mental disorders. Therefore, this scoping review aims to synthesise knowledge on depressed mood, its measurement and interventions among persons with anxiety and/or psychosis.

This scoping review followed Arksey and O'Malley’s framework. Peer-reviewed articles and grey literature published from January 1988 to April 2024 were searched in the following databases: Medline/PubMed, Scopus, Web of Science, Africa-Wide Information, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, SocINDEX, Humanities International Complete, Sabinet, Open Grey and Google Scholar. Articles were screened at title, abstract and full article levels. Data extracted were analysed using thematic analysis and reported following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. We also consulted stakeholders such as lived experience experts, clinicians and researchers to contextualise our findings.

We screened 245 full articles out of the 4039 hits and included 28 articles in this review. Although depressed mood is conceptually different from clinical depression, the terms are used interchangeably in the literature. The prevalence of depressed mood in psychosis was 7.3–33.3%, with no prevalence studies specific to anxiety disorders. Commonly used outcome measures included Beck’s Depression Inventory (n=6) and Patient Health Questionnaire-9 (n=5). Psychosocial conservative interventions such as cognitive–behavioural therapy were the most common interventions. Other interventions, including yoga, pharmacotherapy and Ecology Momentary Interventions, were also reported. All interventions were reported to improve depressed mood, and most were implemented in high-income settings. Stakeholders, including lived experience experts, concurred on the importance of using depressed mood as a transdiagnostic target, viewing it as a ‘window’ for early identification and management of many common mental disorders.

There is a need to clarify the definition and diagnostic cut-off points on common outcome measures of depressed mood. There is also a need for increased research on depressed mood as a viable transdiagnostic target in anxiety and/or psychosis with a special focus on low-to-middle income countries.

Depressed mood is an important and prevalent transdiagnostic target with great promise for early management in anxiety and/or psychosis. Valid diagnostic and measurement tools are developing, and so are the targeted interventions in the context of anxiety and/or psychosis.

Brain and heart conditions are among the leading causes of illness and mortality in Canada. Heart failure is one of the fastest-growing cardiovascular conditions globally, with more than 100 000 Canadians diagnosed each year. Individuals with heart failure are at significantly increased risk of mental health challenges such as depression, anxiety and stress. However, healthcare services often remain siloed, treating physical and mental health separately. This complicates care for individuals with multiple chronic conditions. This multiyear study will adapt, test and accelerate changes to regional care delivery models in Eastern Ontario to optimise brain-heart health and generate knowledge to support the spread and scale of effective interventions that address community needs and priorities. We aim to: (1) identify resource gaps by mapping available services; (2) document strengths and challenges in care delivery; and (3) co-design, pilot test and evaluate an intervention developed based on the priority gap area(s) identified through objectives (1) and (2).

This community-based participatory action research study is led by a research coalition of patient and caregiver partners, care providers and leadership staff from two Ontario Health Teams. In Year 1, we will conduct asset mapping and community consultations with individuals living with heart failure, caregivers, care providers and service organisations to identify care gaps, strengths and opportunities for improvement around modifiable behavioural risk factors and brain-heart health. A scoping review will identify evidence-based strategies to address care gaps and inform the co-design of an intervention focused on supporting individuals with brain-heart interconnected conditions. In Year 2, we will co-design an intervention with community partners for implementation with clinical test sites. Year 3 will involve pilot testing the intervention and conducting outcome and process evaluations. This will inform future spread and scale of the intervention to other brain-heart conditions and new jurisdictions.

The study is approved by the Bruyère Health Research Ethics Board (M16-24-016). Findings will be disseminated through peer-reviewed publications, conference presentations and knowledge mobilisation activities such as social media, community events and local media outreach, as well as through dedicated engagement with Ontario Health partners and the Brain-Heart Interconnectome Network via retreats and collaborative forums.