Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: College students experience high levels of stress. Mindfulness meditation delivered via a mobile application (app) may be an appealing, efficacious way to reduce stress in college students. Objective: To test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile-app (i.e., Calm) compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention’s effect on health behaviors (i.e., sleep disturbance, alcohol consumption (i.e., binge drinking), physical activity, healthy eating (i.e.,fruit and vegetable consumption) and examined the feasibility and acceptability. Methods: This study was a randomized, wait-list control trial with assessments at baseline, post-intervention (8-weeks) and follow-up (12-weeks). Participants were eligible if they were current full-time undergraduate students and 1) at least 18 years of age, 2) scored ≥14 on the Perceived Stress Scale (PSS), 3) owned a smartphone, 4) willing to download the Calm app, 5) willing to be randomized and 7) able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A p-value of ≤ 0.05 was considered statistically significant. Results: Eighty-eight participants were included in the analysis. The mean age (SD), for the intervention group was 20.41 (2.31) years and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between intervention and control groups after adjustment for covariates (all P<0.04) at post-intervention. These effects persisted at follow-up (all P<0.03), except for the non-reacting subscale of mindfuless (p = 0.079). There was a significant interaction between group and time factor in perceived stress (p = 0.002), mindfulness (p<0.001), and self-compassion (p<0.001). Bonferroni post-hoc tests showed significant within-group mean differences for perceived stress in the intervention group (p0.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group x time interaction in models of sleep disturbance was found but no significant effects were found on other health behaviors. The majority of students in the intervention group reported Calm was helpful to reduce stress and stated they would use Calm in the future. The majority was satisfied with using Calm and likely to recommend Calm to other college students. Participation in meditation for the intervention group averaged 38 minutes/week during the intervention and 20 minutes/week at follow-up. Conclusions: Calm is an effective modality to deliver mindfulness meditation to reduce stress and improve mindfulness and self-compassion in stressed college students. The findings presented here provide important information that can be applied to the design of future studies or mental health resources in university programs. Clinical Trial: clinicaltrials.gov, NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810?term=calm+college&rank=1 (archived by WebCite at http://www.webcitation.org/77MgrQjDj

Evidence-based practice is important for behavioral interventions but there is debate on how best to support real-world behavior change. The purpose o

The transition to parenthood is consistently associated with declines in physical activity. In particular, working parents are at risk for inactivity, but research exploring physical activity barriers and facilitators in this population has been scarce. The purpose of this study was to qualitatively examine perceptions of physical activity among working parents. Working mothers (n = 13) and fathers (n = 12) were recruited to participate in one of four focus group sessions and discuss physical activity barriers and facilitators. Data were analyzed using immersion/crystallization in NVivo 10. Major themes for barriers included family responsibilities, guilt, lack of support, scheduling constraints, and work. Major themes for facilitators included being active with children or during children’s activities, being a role model for children, making time/prioritizing, benefits to health and family, and having support available. Several gender differences emerged within each theme, but overall both mothers and fathers reported their priorities had shifted to focus on family after becoming parents, and those who were fitting in physical activity had developed strategies that allowed them to balance their household and occupational responsibilities. The results of this study suggest working mothers and fathers report similar physical activity barriers and facilitators and would benefit from interventions that teach strategies for overcoming barriers and prioritizing physical activity amidst the demands of parenthood. Future interventions might consider targeting mothers and fathers in tandem to create an optimally supportive environment in the home.

Myeloproliferative neoplasm (MPN) patients suffer from significant symptoms, inflammation and reduced quality of life. Yoga improves these outcomes in other cancers, but this hasn’t been demonstrated in MPNs. The purpose of this study was to: (1) explore the limited efficacy (does the program show promise of success) of a 12-week online yoga intervention among MPN patients on symptom burden and quality of life and (2) determine feasibility (practicality: to what extent a measure can be carried out) of remotely collecting inflammatory biomarkers. Patients were recruited nationally and randomized to online yoga (60 min/week of yoga) or wait-list control (asked to maintain normal activity). Weekly yoga minutes were collected with Clicky (online web analytics tool) and self-report. Those in online yoga completed a blood draw at baseline and week 12 to assess inflammation (interleukin-6, tumor necrosis factor-alpha [TNF-α]). All participants completed questionnaires assessing depression, anxiety, fatigue, pain, sleep disturbance, sexual function, total symptom burden, global health, and quality of life at baseline, week seven, 12, and 16. Change from baseline at each time point was computed by group and effect sizes were calculated. Pre-post intervention change in inflammation for the yoga group was compared by t-test. Sixty-two MPN patients enrolled and 48 completed the intervention (online yoga = 27; control group = 21). Yoga participation averaged 40.8 min/week via Clicky and 56.1 min/week via self-report. Small/moderate effect sizes were generated from the yoga intervention for sleep disturbance (d = − 0.26 to − 0.61), pain intensity (d = − 0.34 to − 0.51), anxiety (d = − 0.27 to − 0.37), and depression (d = − 0.53 to − 0.78). A total of 92.6 and 70.4% of online yoga participants completed the blood draw at baseline and week 12, respectively, and there was a decrease in TNF-α from baseline to week 12 (− 1.3 ± 1.5 pg/ml). Online yoga demonstrated small effects on sleep, pain, and anxiety as well as a moderate effect on depression. Remote blood draw procedures are feasible and the effect size of the intervention on TNF-α was large. Future fully powered randomized controlled trials are needed to test for efficacy. This trial was retrospectively registered with clinicaltrials.gov (ID: NCT03503838 ) on 4/19/2018.

The objective of this study was to 1) determine the effects of a meditation app on depression and anxiety in adults with sleep disturbance, and 2) explore the potential mediating effects of fatigue, daytime sleepiness, and pre-sleep arousal on the relationship between use of the meditation app and changes in depression and anxiety. Participants were 239 adults with elevated insomnia symptoms (i.e., scores ≥ 10 on the Insomnia Severity Index) and limited or no previous experience with meditation. Depression, anxiety, fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, four weeks, and eight weeks. Repeated-measures ANCOVAs assessed intervention effects on depression and anxiety. Mediation models were estimated using the PROCESS macro. Participants in the meditation group had more improvement in depression and anxiety symptoms during the intervention period than did those in the control group. Changes in somatic and cognitive pre-sleep arousal at mid-intervention fully mediated effects on depression and partially mediated effects on anxiety. There were no significant indirect effects of fatigue and daytime-sleepiness on changes in mental health. A meditation app may improve depression and anxiety in adults with sleep disturbance, with effects being driven by improvements in pre-sleep arousal. Future studies should consider targeting pre-sleep arousal to improve mental health in this population.

Background: About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a “stretch and tone” control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health. Methods: Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable. Results: Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control). Conclusions: This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial. Trial registration: ClinicalTrials.gov. NCT02925481. Registered 10–04-16.