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.

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.

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.

NCT06919133.

Version 6, January 2026.

While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.

All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.

This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.

NCT05373498.

Loneliness and adverse childhood experiences (ACEs) constitute significant risk factors for mental disorders, with loneliness emerging as a serious global public health concern. Recent research highlights the role of loneliness as a potential link between early life adversities and current psychopathology. However, most studies have been conducted in high-income, highly individualistic countries. This cross-sectional study explores the interplay between loneliness, social network size, recalled ACEs and depressive symptoms in Ethiopia—a low-income and collectivistic cultural context.

The study included 125 psychiatric outpatients at Jimma University Medical Center in Southwest Ethiopia diagnosed with major depressive disorder, bipolar disorder or psychotic disorders, as well as 131 non-clinical participants. Trained interviewers administered the University of California, Los Angeles (UCLA) Loneliness Scale, the Childhood Trauma Questionnaire, the Social Network Index and the WHO-5 Well-Being Index. We used Mann-Whitney U tests, partial correlation and mediation analysis for data analysis.

We found mild-to-moderate correlations between loneliness and ACEs (clinical group: rho=0.29, p1b₁=0.07, 95% CI (0.02 to 0.13); non-clinical group: indirect effect a₁b₁=0.03, 95% CI (0.01 to 0.07)). In contrast, social network size was neither correlated with ACEs nor did it mediate the association between ACEs and depressive symptoms in either group.

This study replicates previous findings that loneliness—rather than social network size—is associated with ACEs and mediates their impact on depressive symptoms. These results support the transcultural and transdiagnostic relevance of loneliness as a universal psychological mechanism, independent of societal structure.