IntroductionMany patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint).Methods and analysisThe study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18–65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate.Ethics and disseminationThe Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations.Trial registration numberGerman Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

Different COVID-19 vaccines have been approved for underage children, so parents and caregivers currently face the decision of whether to vaccinate their children against COVID-19 or not. Due to the rather moderate vaccine acceptance among parents across different countries, the objective of the present study was to investigate the relationship between different psychological, demographic, and behavioral factors related to the acceptance of the COVID-19 vaccine for underage children among parents. In particular, vaccination attitudes, whether parents have been vaccinated against COVID-19 themselves, COVID-19 fear, attitude towards COVID-19 policy measures, governmental trust, subjective level of information, perceived risk of disease progression, and perceived risk of vaccine side effects were the variables of interest. The study adopted a cross-sectional study design, and the sample consisted of 2405 participants. A network analysis was conducted to investigate the associations and interconnection among these variables. The results showed that, in particular, compliance, confidence in the safety of vaccines, whether parents have been vaccinated against COVID-19 themselves, trust in the governmental system, fear of COVID-19, and the parents’ age were directly related to the acceptance of the COVID-19 vaccine for children. To increase compliance and confidence in the vaccines’ safety among parents, promotion campaigns should provide more information concerning the vaccines’ safety, particularly for younger parents who are not vaccinated against COVID-19 themselves.

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Since introducing the first non-pharmaceutical interventions (NPIs) to decelerate the spread of the virus, European governments have highlighted the role of “solidarity”. However, the role and levels of solidarity, especially during the past lockdowns, is uncertain. The present study thus explores the levels, the role, and the distribution of received and demonstrated interpersonal solidarity during the COVID-19 pandemic. This pooled cross-sectional study was conducted from March 2020 to March 2021 in Germany, including 19,977 participants. Levels of solidarity between the first and the second lockdowns in Germany were compared, possible predictors were examined, and three clusters were defined to unveil distributional patterns of solidarity reception and/or demonstration. To compare solidarity levels between the first and the second lockdowns in Germany, a dummy-coded lockdown variable was introduced and regressed on the two solidarity items. To identify predictors of received and demonstrated solidarity, two multiple linear regression models were computed, testing several demographic and psychological factors. For further exploratory analyses, clusters of “helpers”, “non-helpers”, and “help-receivers and helpers” were computed based on a k-means cluster analysis. Results revealed a lower level of solidarity during the second lockdown compared with the first one. Demonstrated solidarity was positively predicted by adherent safety behavior to avoid COVID-19 infection and by middle age, and negatively by depression symptoms, male gender, and high age. Received solidarity was positively predicted by higher age, by both adherent and dysfunctional safety behavior in avoidance of COVID-19 infection, and by lower educational level. “Helpers” reported little received solidarity but demonstrated high solidarity, “non-helpers” showed both little demonstrated and received solidarity, and “help-receivers and helpers” showed middle–high received and demonstrated solidarity. The three clusters differed the most regarding the variables of age, adherent and dysfunctional safety behavior, fear of COVID-19, subjective risk perceptions regarding contraction of COVID-19 and the respective consequences, and trust in governmental interventions in response to COVID-19. The decrease in interpersonal solidarity over the course of the COVID-19 pandemic, as well as its predictors, should be considered regarding prospective impositions. Furthermore, as depressive symptoms were identified to negatively predict interpersonal solidarity, the adequate provision of mental health services, especially during the COVID-19 pandemic, becomes even more important.