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Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial

Por: Faurholt-Jepsen · M. · Dyreholt · M. S. · Kyster · N. B. · Iversen · N. · Kortsen · E. M. · Amann · B. L. · Hogg · B. · Gatto · D. · Cordoba · C. d. · Petrovic · M. · Allenhof · C. · Schnitzspahn · K. · Reich · H. · Budtz-Jorgensen · E. · Kessing · L. V. · Hegerl · U.
Introduction

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

Methods and analysis

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

Ethics and dissemination

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

Trial registration number

NCT06919133.

Protocol version

Version 6, January 2026.

Evidence map of oesophageal surgery: protocol for a living systematic review and meta-analysis

Por: Benignus · C. · Schiedeck · T. · Avramovska · I. · Evers · L. M. · Giulini · L. · Heger · P. · Diener · M. K. · Hüttner · F. J.
Introduction

Surgery represents the cornerstone for the treatment of several benign and malignant oesophageal disorders. Yet synthesising the growing body of evidence from clinical research is becoming increasingly challenging. Evidence mapping with living systematic reviews (SRs) and living meta-analyses offers a structured, continuously updated approach to navigating emerging data. This study aims to provide a real-time, interactive resource to support evidence-based decision-making for oesophageal surgery.

Methods and analysis

This study follows PRISMA guidelines and uses the EVIglance Studio web application to develop a living evidence map in oesophageal surgery. A systematic literature search will be conducted across the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and MEDLINE (PubMed) to identify randomised controlled trials (RCTs) and SRs related to oesophageal surgery, without any date or language restrictions. Study selection and data extraction will be performed independently by two reviewers. Key clinical and surgical outcomes, including morbidity, mortality, quality of life and oncological endpoints, will be extracted. Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system will be applied to evaluate the certainty of evidence. If at least three randomised trials address the same research question, a living meta-analysis will be conducted using random-effects models. The evidence map will be updated at least every 6 months.

Ethics and dissemination

This study does not involve individual patient data or any private information. Therefore, ethical approval is not required. As it uses only publicly available data, this study design qualifies as exempt from institutional review. The resulting evidence map is designed to support fast and structured access to high-quality surgical data - an approach not yet available in oesophageal surgery. The tool is expected to aid patients, clinicians and researchers alike by improving access to reliable information, supporting clinical decision-making and highlighting gaps in current evidence. On completion, results will be published in an open-access format and made permanently accessible via www.evidencemap.surgery, with continuous updates.

PROSPERO registration number

CRD420251022736 (https://www.crd.york.ac.uk/prospero/)

Acute gastroenteritis and associated factors among under-five children visiting public hospitals in Jigjiga City, Somali Region, Ethiopia: a hospital-based cross-sectional study

Por: Getahun · M. A. · Ayehubizu · L. M. · Ahmed · A. M. · Ali · S. Y. · Abdilahi · A. M. · Shegere · M. M.
Objective

The study aims to assess the magnitude of acute gastroenteritis and associated factors among under-five children visiting public hospitals in Jigjiga City, Somali Region, Ethiopia.

Design

A hospital-based cross-sectional study design was used to carry out the study. We then employed a systematic random sampling technique through face-to-face interviews to gather the data. A structured questionnaire consisting of socio-demographic, behavioural, environmental and clinical factors was developed after reviewing relevant literature.

Setting

The study was conducted in public hospitals located in Jigjiga City, Somali Region, Ethiopia.

Participants

A total of 353 under-five children visiting public hospitals were involved in the study.

Outcome measures

The primary outcome of the study was the prevalence of acute gastroenteritis.

Result

The 2-week prevalence of acute gastroenteritis among under-five children was 24.6% (95% CI 23.4% to 25.9%). The study found strong links between acute gastroenteritis and having a household greater than five (adjusted OR (AOR)=2.94, 95% CI 1.55 to 5.60), an unprotected source of drinking water (AOR=2.74, 95% CI 1.29 to 5.82), unimproved latrine facilities (AOR=3.15, 95% CI 1.26 to 7.78), the presence of faeces around the latrine (AOR=3.53, 95% CI 1.77 to 7.03) and mothers or caregivers’ history of diarrhoea over the past 2 weeks (AOR=6.23, 95% CI 3.22 to 12.06).

Conclusion

The overall prevalence of acute gastroenteritis in Jigjiga City was relatively high in the 2-week period. Having a household greater than five, an unprotected source of drinking water and unimproved latrine facilities was a significant predictor of acute gastroenteritis. Additionally, the presence of faeces around the latrines and the history of diarrhoea in mothers or caregivers over the past 2 weeks were strongly linked to acute gastroenteritis.

Magnitude of low back pain and associated factors among primary school teachers in Borama City, Somaliland: an institutional-based cross-sectional study

Por: Shegere · M. M. · Abdilahi · A. M. · Ali · S. Y. · Farah · N. B. · Adem · B. A. · Nour · A. J.
Objectives

The goal of the study was to determine the magnitude and contributing factors of low back pain among primary school teachers in Borama Town, Somaliland.

Design

An institution-based descriptive cross-sectional study design was employed. Simple random sampling was used to select the study units from each school.

Setting

The study was conducted in Borama, Somaliland.

Participants

A total of 268 primary school teachers participated in the study.

Outcome measures

The primary outcome of the study was the prevalence of low back pain.

Results

The study found that 51.5% of school teachers had low back pain. There was a strong link between low back pain and having a higher Body Mass Index (adjusted OR (AOR)=2.63) and stress at work (AOR=3.34). Sleep disturbance (AOR=1.73), lifting heavy materials (AOR=1.67) and a history of low back injury (AOR=2.12) were also significant predictors of low back pain.

Conclusion

More than half of primary school teachers had low back pain over the past 12 months. Higher Body Mass Index, history of low back injury, stress at work, lifting heavy material and sleep disturbance were significant and independent predictors of low back pain among primary school teachers.

Cardiovascular disease risk and its determinants among hypertensive patients in Eastern Ethiopia: an institution-based cross-sectional study

Por: Ali · S. Y. · Shegere · M. M. · Abdulahi · A. · Hussein · A. A. · Abdinur · A. H. · Muhumed · A. A. · Ayele · Z. A. · Abebe · D. · Abdu · S. M. · Gemechu · W. D.
Objectives

This study aims to assess the level of cardiovascular disease (CVD) risk and its associated determinants among hypertensive patients in Jigjiga, Somali Region, Ethiopia using the WHO 10-year CVD risk score.

Design

An institution-based cross-sectional study design was employed.

Setting

Hypertensive patients aged 40–74 years in two public hospitals in Jigjiga, Somali Region, Ethiopia, from 20 December 2023 to 20 February 2024.

Participants

Randomly selected 344 hypertensive patients aged 40–74 years with a duration of 1 year or more from the time of diagnosis and at least having 6-month follow-up.

Primary outcome measures

10-year CVD risk level was assessed by using WHO 10-year CVD risk score. Risk levels were categorised as low (

Secondary outcome measures

Associated factors influencing CVD risk.

Results

The study included 341 hypertensive individuals, with a 99.1% response rate. Of the respondents, 58.9% were men. The overall prevalence of CVD risk within the coming 10 years was 134 (39.3%; 95% CI: 34.1% to 44.5%). Multivariable logistic regression analysis identified age, khat chewing, smoking and comorbid conditions as significant independent predictors of CVD risk. Specifically, individuals aged 60–69 years had an adjusted OR (AOR) of 3.97 (95% CI: 1.94 to 8.16) and those aged 70–74 years had an AOR of 2.99 (95% CI: 1.57 to 5.71). Khat chewers had an AOR of 2.58 (95% CI: 1.22 to 5.46), smokers an AOR of 3.44 (95% CI: 1.59 to 7.48) and individuals with comorbidities an AOR of 2.42 (95% CI: 1.47 to 3.99).

Conclusion

There is a significant increase in 10-year CVD risk among hypertensive patients in the study area. Age, khat chewing, smoking and comorbidities were independent predictors. Regular CVD risk screening for older patients, focused health education to reduce khat and tobacco use and integrated management of comorbidities are essential to lower future cardiovascular risk.

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