Reducing Burnout through a Mindful Meditation Mobile App: A Randomized Controlled Trial

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

Download Full-text

One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial (Preprint)

10.2196/preprints.16745 ◽

2019 ◽

Author(s):

Chandra Y Osborn ◽

Ashley Hirsch ◽

Lindsay E Sears ◽

Mark Heyman ◽

Jennifer Raymond ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Controlled Trial ◽

Mobile App ◽

Analysis Of Covariance ◽

Activity Tracker ◽

Randomized Controlled ◽

Hemoglobin A ◽

The One

BACKGROUND In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop’s digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A1c level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A1c level of 22.2 mg/dL (–0.80%). However, the added value of integrated activity trackers is unknown. OBJECTIVE We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A1c level of adults with type 1 diabetes. METHODS Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop’s full solution and the activity tracker, with a laboratory hemoglobin A1c level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A1c, were used to evaluate 3-month hemoglobin A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses. RESULTS The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A1c level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). CONCLUSIONS Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A1c level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. CLINICALTRIAL ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

Download Full-text

Using Smartphone-Based Psychoeducation to Reduce Postnatal Depression Among First-Time Mothers: Randomized Controlled Trial (Preprint)

10.2196/preprints.12794 ◽

2018 ◽

Author(s):

Ko Ling Chan ◽

Wing Cheong Leung ◽

Agnes Tiwari ◽

Ka Lun Or ◽

Patrick Ip

Keyword(s):

Randomized Controlled Trial ◽

Postnatal Depression ◽

Controlled Trial ◽

Mobile App ◽

Control Group ◽

Randomized Controlled ◽

First Time Mothers ◽

Expectant Mothers ◽

First Time

BACKGROUND Smartphone-based psychoeducation interventions may be a low-cost, user-friendly alternative to resource-consuming, face-to-face antenatal classes to educate expectant mothers. OBJECTIVE This study aimed to empirically examine whether such an intervention would lead to reduced postnatal depression, anxiety, or stress and result in a better health-related quality of life. METHODS A single-blind randomized controlled trial was conducted in Hong Kong. All first-time expectant mothers with less than 24 weeks of gestation remaining and attending the antenatal clinic at a public hospital were included. Participants were assigned to the intervention group or the control group by drawing lots. The lots, presented in sealed opaque envelopes, were randomly designated as “intervention” or “control” by stratified randomization. The intervention, a psychoeducational mobile app, was provided in addition to the treatment as usual (TAU) services from the hospital. Follow up with participants took place at 4 weeks postpartum. The primary outcome was the difference in the levels of antenatal and postnatal depression, assessed by the Edinburgh Postnatal Depression Scale (EPDS). The intention-to-treat approach was employed in the analyses. RESULTS The final sample was 660 expectant mothers (nintervention=330 and ncontrol=330). The mean difference in EPDS scores between the two groups was −0.65 (95% CI −1.29 to 0.00; P=.049) after adjusting for confounding factors. Associations were found between participation in the intervention and reduced depression, and attendance in TAU classes and increased stress levels. CONCLUSIONS The smartphone-based intervention plus TAU services was effective in reducing postnatal depression at 4 weeks postpartum compared with a control condition of TAU only, making this a cost-effective alternative to TAU education for expectant mothers. Limitations of the study included the short postpartum period after which the follow-up assessment was conducted and the inclusion of first-time mothers rather than all mothers. CLINICALTRIAL HKU Clinical Trials Registry HKUCTR-2024; http://www.hkuctr.com/Study/Show/ 34f62a2f6d594273a290491827206384

Download Full-text