BMJ open
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Randomized Controlled Trial Multicenter Study
Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).
To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. ⋯ Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.
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The SARS-CoV-2 (COVID-19) pandemic poses immense challenges for national and international healthcare systems. Especially in times of social isolation and governmental restrictions, mental health should not be neglected. Innovative approaches are required to support psychologically burdened people. The e-mental health intervention 'CoPE It' has been developed to offer manualised and evidence-based psychotherapeutic support adapted to COVID-19-related issues in order to overcome psychological distress. In our study, we aim to assess the efficacy of the e-mental health intervention 'CoPE It' in terms of reducing distress (primary outcome), depression and anxiety symptoms as well as improving self-efficacy, quality of life and mindfulness (secondary outcomes). Furthermore, we want to evaluate the programme's usability, feasibility and participants' satisfaction with 'CoPE It' (tertiary outcome). ⋯ The Ethics Committees of the University of Duisburg-Essen (20-9243-BO) and University of Tübingen (469/2020BO) approved the study. Results will be published in peer-reviewed journals and conference presentations.