Background: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. Objective: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. Methods: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. Results: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference –0.04; 95% CI –0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (–0.29; 95% CI –0.48 to –0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (–0.25; 95% CI –0.49 to –0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. Conclusions: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. Trial Registration: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.

Background: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. Objective: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Methods: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. Results: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] −0.51, 95% CI −0.69 to −0.33; 2018/2859, 70.58% of the participants; I2=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD −0.67, 95% CI −0.79 to −0.55), compared with trials with participants exhibiting mild to moderate depression (SMD −0.15, 95% CI −0.43 to −0.12). Conclusions: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. Trial Registration: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689

Breast milk constitutes a dietary source of leptin, adiponectin and microRNAs (miRNAs) for newborns. Expression of miRNAs previously associated with maternal obesity, leptin or adiponectin function were assessed and their impact on infant weight analyzed. Milk samples were collected (at month 1, 2, and 3) from a cohort of 59 healthy lactating mothers (38 normal-weight and 21 overweight/obese (BMI ≥ 25)), and infant growth was followed up to 2 years of age. Thirteen miRNAs, leptin and adiponectin were determined in milk. Leptin, adiponectin and miRNA showed a decrease over time of lactation in normal-weight mothers that was altered in overweight/obesity. Furthermore, negative correlations were observed in normal-weight mothers between the expression of miRNAs in milk and the concentration of leptin or adiponectin, but were absent in overweight/obesity. Moreover, miRNAs negatively correlated with infant BMI only in normal-weight mothers (miR-103, miR-17, miR-181a, miR-222, miR-let7c and miR-146b). Interestingly, target genes of milk miRNAs differently regulated in overweight/obesity could be related to neurodevelopmental processes. In conclusion, a set of miRNAs present in breast milk, in close conjunction with leptin and adiponectin, are natural bioactive compounds with the potential to modulate infant growth and brain development, an interplay that is disturbed in the case of maternal overweight/obesity.

Aim: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness‐based approaches on the mental health of healthcare workers at the frontline against COVID‐19 in Spain.Design: We will carry out a two‐week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention.Methods: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID‐19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS‐21 questionnaire—primary endpoint), insomnia (ISI), burnout (MBI‐HSS), post‐traumatic stress disorder (DTS), and self‐efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.Discussion: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context.Impact: Despite the lack of solid evidence about their effectiveness, mobile‐based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.Clinical trial registration: NCT04393818 (ClinicalTrials.gov identifier).Approved funding: May 2020.