Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial
Jennifer Huberty, Jeni Green, Megan E. Puzia, Linda Larkey, Breanne Laird, A. Vranceanu, Robert D. Vlisides-Henry, Michaela Irwin
PLoS One January 7, 2021 DOI: 10.1371/journal.pone.0244717 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 263 |
| Population | Adults with sleep disturbance (Insomnia Severity Index Score >10) |
| Dose | ≥10 minutes/day |
| Duration | 8-week intervention; assessments at baseline, 4 weeks, and 8 weeks |
| Measures | Insomnia Severity Index, fatigue, daytime sleepiness, pre-sleep arousal, sleep quality |
| Topics | Meditation |
| Registration | NCT04045275 |
| Key findings | Using the Calm mindfulness meditation app for eight weeks significantly decreased daytime fatigue, daytime sleepiness, and cognitive and somatic pre-sleep arousal compared with a wait-list control group. Within the intervention group, greater app use was associated with improvements in sleep quality. The authors conclude the app can be used to treat these sleep-related symptoms in adults with sleep disturbance. |
Abstract
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 21
- A mindfulness meditation mobile app improves depression and anxiety in adults with sleep disturbance: Analysis from a randomized controlled trial General Hospital Psychiatry September 11, 2021
- The meditation app revolution. American Psychologist August 7, 2025
- Mindful mindfulness reporting: Media portrayals of scientific evidence for meditation mobile apps Public Understanding of Science February 3, 2023
- Impacts of the Mindfulness Meditation Mobile App Calm on Undergraduate Students' Sleep and Emotional State: Pilot Randomized Controlled Trial. JMIR Formative Research June 11, 2025
- Meditation as a non-pharmacological treatment for narcolepsy: A literature review. Sleep Medicine June 24, 2025
and 16 more in the library
Cites 10
- Meditation Programs for Psychological Stress and Well-being JAMA Internal Medicine January 6, 2014
- The effect of mindfulness meditation on sleep quality: a systematic review and meta‐analysis of randomized controlled trials Annals of the New York Academy of Sciences December 21, 2018
- Mindfulness Meditation and Improvement in Sleep Quality and Daytime Impairment Among Older Adults With Sleep Disturbances JAMA Internal Medicine February 16, 2015
- Feasibility and Acceptability of a Mobile Mindfulness Meditation Intervention Among Women: Intervention Study. JMIR mHealth and uHealth June 2, 2020
- Efficacy of the Mindfulness Meditation Mobile App “Calm” to Reduce Stress Among College Students: Randomized Controlled Trial JMIR mHealth and uHealth June 1, 2019
and 5 more in the library