Objectives This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Trial design Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for 30 days or to a control group (no usage of meditation app) with a 1:1 equivalence allocation ratio. Participants Inclusion Criteria: Participants must be 18 or older, have a smartphone, able to download apps to their smartphone, must be fluent in the English language, able to complete surveys on their own, and must be in the United States for the duration of the study. Exclusion Criteria: Current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent participation. All data will be collected through the Insight Timer Meditation App and Google Forms. This trial is being conducted through the Lake Erie College of Osteopathic Medicine in Erie, PA, with all data collected digitally. Intervention and comparator Intervention: Participants will be sent a link to a pre-intervention survey prior to first use of the mindfulness app. Participants will be instructed to use the Insight Timer app for 10 minutes daily for 30 days. At the end of the 30-day intervention period, participants will be sent a link for the post-intervention survey. Two months after the conclusion of the 30-day intervention period, participants will be sent a link for another post-intervention survey. Comparator: Participants will receive the same surveys, but will not use any mindfulness app for the 30-day intervention period. After this 30-day period, participants are invited to use the Insight Timer app if they so choose. Main outcomes The main outcomes are (1) anxiety as assessed by survey questions adapted from the GAD7, comparing pre-intervention to post-30-days of app usage and (2) well-being as assessed by survey questions adapted from the WHO-5, comparing pre-intervention and post-30-days of app usage. Randomization Participants will be allocated to interventions via a block random sequence generator with a 1:1 allocation ratio in blocks of 8. Blinding (masking) No masking is being used in this study (open label). Numbers to be randomized (sample size) Approximately 75 participants will be randomized to each group, with an estimated enrollment of 150 participants. Trial status This study is protocol version number 27-126 and was approved on May 10, 2020. Recruitment began on August 19, 2020 and will end February 28, 2021. The study is estimated to complete on April 30, 2021. Trial registration This trial was registered to ClinicalTrials.gov on 30 April 2020. The ClinicalTrials.gov Identifier is NCT04369378. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Introduction This study examined the effect of 10-minute daily meditation app usage for 30 days on adult anxiety and mental well-being during the first year of the COVID-19 pandemic. Methods Participants were randomized into intervention (10 minutes of daily usage of the Insight Timer app) or control groups. Participants completed surveys to assess anxiety and well-being pre- and post-study. Data were analyzed using t-tests, analysis of variance (ANOVA), or nonparametric equivalents. Results Pre-study results were comparable between groups. The pre- vs. post-study General Anxiety Disorder-7 (GAD-7) scores for anxiety decreased in the intervention group (n=18, median 5.5 vs. 3.0 (pre vs. post), p=0.0233, d=0.50), but not in the control group (n=28). The intervention group had a lower median GAD-7 score than the control group post-study (3.0 vs. 8.0, p=0.0223, d=0.35). Pre- vs. post-study mean 5-item World Health Organization Well-Being Index (WHO-5) scores were improved in both the control (11.6 vs. 12.9 (pre vs. post), p=0.0408, d=0.36) and intervention groups (12.0 vs. 16.3 (pre vs. post), p=0.0001, d=0.77), although it was higher in the intervention group (16.3 vs. 12.9, p=0.0056, d=0.88). Conclusion Ten minutes of daily meditation app usage for 30 days may reduce anxiety and improve well-being in adults during the COVID-19 pandemic.

Background Nearly one‐third of medical students experience significantly higher anxiety levels as compared to their non‐medical counterparts. Elevated anxiety levels increase the likelihood of developing depression and result in loss of personal relationships and a lower quality of life. Specifically, in medical students, increased anxiety is correlated with decreased empathy, professionalism, and may negatively impact academic performance. Peer‐support programs benefit not only student participants but also peer volunteers. Programs like these provide psychosocial support that students are otherwise without, as well as encourage professional development. We hypothesized that peer‐support participants will experience decreased overall and exam‐related anxiety, feel more prepared, and perform higher academically after participating in the program. Design A peer‐support program was designed and implemented at the Lake Erie College of Osteopathic Medicine in Erie, PA during the Fall of 2020. Students participants were recruited from the Master's in Medical Science (M.M.S.) program to participate. First‐year medical students (MS1s) who matriculated from the M.M.S. program were recruited to lead the peer support sessions. Three sessions were held throughout Fall 2020 and covered topics including goal setting, time management, and burnout and coping. The final session is scheduled for January 2021 and will cover self‐reflection. M.M.S. participants were randomly assigned to one of 11 groups led by an MS1 volunteer and given 30 minutes to discuss the session topic. M.M.S. students were surveyed at five different time points by the State‐Trait Anxiety Inventory (STAI) and the General Anxiety Disorder‐7 (GAD‐7) questionnaires. MS1 students were surveyed at two time points, using the STAI. Participant opinion was also collected using Likert scale and open‐ended questions. Results A total of 67 M.M.S. students attended the first session, with 11 MS1 students volunteering to lead the sessions. Initial STAI results are consistent with that of an average college student and significantly higher than their age group, as expected. Similarly, GAD‐7 results showed an expected increase in exam‐related anxiety throughout the semester, specifically experiencing more restlessness and irritability. Written responses suggest students appreciated the opportunity to ask MS1 volunteers questions, discuss relevant topics, and form relationships otherwise difficult to due to curricula being entirely online. Full results are pending the final session. Conclusion Students transitioning to professional‐level education find peer‐support a helpful tool to improve their preparedness. Full conclusions will be drawn upon completion of the final session and analysis of the post‐test STAI results.