Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

Jennifer L Huberty, Jeni Green, Megan E Puzia, Linda Larkey, Breanne Laird, Ana-Maria Vranceanu, Robert Vlisides-Henry, Michael R Irwin, Jennifer L Huberty, Jeni Green, Megan E Puzia, Linda Larkey, Breanne Laird, Ana-Maria Vranceanu, Robert Vlisides-Henry, Michael R Irwin

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.

Conflict of interest statement

The authors of this paper have read the journal's policy and have the following competing interests: Dr. Huberty serves in a consultant role as the Director of Science for Calm. She oversees Calm’s Scientific Advisory Board (SAB) and consults on an as-needed basis to ensure the quality of Calm’s science. She has no specific obligations to the company nor does she own stock in the company or receive financial reward from the sale of the product. Dr. Huberty conducts investigator-initiated research with Calm as a partner, but Calm does not financially support her research. Drs. Vranceanu, Larkey, and Irwin also serve on Clam's SAB. They do not financially benefit from the sale of the product nor do they have stock in the company. Dr. Puzia is a paid employee of Behavioral Research and Analytics, LLC. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Consort diagram.
Fig 1. Consort diagram.
Fig 2. Average weekly adherence to the…
Fig 2. Average weekly adherence to the intervention.

References

    1. Liu Y., Wheaton A. G., Chapman D. P., Cunningham T. J., Lu H., and Croft J. B., “Prevalence of healthy sleep duration among adults—United states, 2014,” Morb. Mortal. Wkly. Rep., 2016, 10.15585/mmwr.mm6506a1
    1. Foundation U. H., “America’s Health Rankings analysis of CDC, Behavioral Risk Factor Surveillance System,” 2020.
    1. Kruse J. A., “Clinical Methods: The History, Physical, and Laboratory Examinations,” JAMA J. Am. Med. Assoc., 1990, 10.1001/jama.1990.03450210108045
    1. Morin C. M. and Jarrin D. C., “Epidemiology of insomnia: Prevalence, course, risk factors, and public health burden,” Sleep Medicine Clinics. 2013, 10.1016/j.jsmc.2013.05.002
    1. Shallcross A. J., Visvanathan P. D., Sperber S. H., and Duberstein Z. T., “Waking up to the problem of sleep: can mindfulness help? A review of theory and evidence for the effects of mindfulness for sleep,” Current Opinion in Psychology. 2019, 10.1016/j.copsyc.2018.10.005
    1. Ferrie J. E., Kumari M., Salo P., Singh-Manoux A., and Kivimäki M., “Sleep epidemiology-A rapidly growing field,” International Journal of Epidemiology. 2011, 10.1093/ije/dyr203
    1. Irwin M. R., “Why Sleep Is Important for Health: A Psychoneuroimmunology Perspective,” Annu. Rev. Psychol., 2015, 10.1146/annurev-psych-010213-115205
    1. Center for Disease Control and Prevention, “Short Sleep Duration Among US Adults,” 2017. 10.14423/SMJ.0000000000000632
    1. Singareddy R. et al., “Risk factors for incident chronic insomnia: A general population prospective study,” Sleep Med., 2012, 10.1016/j.sleep.2011.10.033
    1. Ballesio A. et al., “The effectiveness of behavioural and cognitive behavioural therapies for insomnia on depressive and fatigue symptoms: A systematic review and network meta-analysis,” Sleep Medicine Reviews. 2018, 10.1016/j.smrv.2017.01.006
    1. Abad V. C. and Guilleminault C., “Diagnosis and treatment of sleep disorders: A brief review for clinicians,” Dialogues in Clinical Neuroscience. 2003. 10.31887/DCNS.2003.5.4/vabad
    1. Irwin M. R., Cole J. C., and Nicassio P. M., “Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age,” Heal. Psychol., 2006, 10.1037/0278-6133.25.1.3
    1. Williams J., Roth A., Vatthauer K., and McCrae C. S., “Cognitive behavioral treatment of Insomnia,” Chest, 2013, 10.1378/chest.12-0731
    1. Black D. S., O’Reilly G. A., Olmstead R., Breen E. C., and Irwin M. R., “Mindfulness Meditation and Improvement in Sleep Quality and Daytime Impairment Among Older Adults With Sleep Disturbances,” JAMA Intern. Med., vol. 175, no. 4, p. 494, April 2015, 10.1001/jamainternmed.2014.8081
    1. Irwin M. R. et al., “Tai Chi Chih compared with cognitive behavioral therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A randomized, partially blinded, noninferiority trial,” J. Clin. Oncol., 2017, 10.1200/JCO.2016.71.0285
    1. Morin C. M., LeBlanc M., Daley M., Gregoire J. P., and Mérette C., “Epidemiology of insomnia: Prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors,” Sleep Med., 2006, 10.1016/j.sleep.2005.08.008
    1. Morgan K., Gregory P., Tomeny M., David B. M., and Gascoigne C., “Self-help treatment for insomnia symptoms associated with chronic conditions in older adults: A randomized controlled trial,” J. Am. Geriatr. Soc., 2012, 10.1111/j.1532-5415.2012.04175.x
    1. Rusch H. L. et al., “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. 2019, 10.1111/nyas.13996
    1. Kanen J., Nazir R., Sedky K., and Pradhan B., “The Effects of Mindfulness-Based Interventions on Sleep Disturbance: A Meta-Analysis,” Adolesc. Psychiatry (Hilversum)., 2015, 10.2174/2210676605666150311222928
    1. Goyal M. et al., “Meditation Programs for Psychological Stress and Well-being,” JAMA Intern. Med., 2014, 10.1001/jamainternmed.2013.13018
    1. Winbush N. Y., Gross C. R., and Kreitzer M. J., “The Effects of Mindfulness-Based Stress Reduction on Sleep Disturbance: A Systematic Review,” Explor. J. Sci. Heal., 2007, 10.1016/j.explore.2007.08.003
    1. Gong H. et al., “Mindfulness meditation for insomnia: A meta-analysis of randomized controlled trials,” J. Psychosom. Res., vol. 89, pp. 1–6, October 2016, 10.1016/j.jpsychores.2016.07.016
    1. Wang X., Li P., Pan C., Dai L., Wu Y., and Deng Y., “The Effect of Mind-Body Therapies on Insomnia: A Systematic Review and Meta-Analysis,” Evidence-based Complementary and Alternative Medicine. 2019, 10.1155/2019/9359807
    1. Pew Research Center, “Mobile Fact Sheet,” 2019.
    1. Tomlinson M., Rotheram-Borus M. J., Swartz L., and Tsai A. C., “Scaling up mHealth: where is the evidence?,” PLoS Med., vol. 10, no. 2, 2013. 10.1371/journal.pmed.1001382
    1. Mani M., Kavanagh D. J., Hides L., and Stoyanov S. R., “Review and Evaluation of Mindfulness-Based iPhone Apps,” JMIR mHealth uHealth, 2015, 10.2196/mhealth.4328
    1. Ong J. C. and Moore C., “What do we really know about mindfulness and sleep health?,” Current Opinion in Psychology. 2020, 10.1016/j.copsyc.2019.08.020
    1. Eckert R., Larkey L., Joeman L., and Mesa R., “Myeloproliferative neoplasm patients experience of using a consumer-based mobile meditation app to improve fatigue: Informing future directions Type of Paper: Original Paper Jennifer Huberty, PhD* College of Health Solutions,” 2019.
    1. Huberty J., Vranceanu A. M., Carney C., Breus M., Gordon M., and Puzia M. E., “Characteristics and usage patterns in a convenience sample of paid subscribers to calm meditation app: Cross-sectional survey,” JMIR mHealth and uHealth. 2019, 10.2196/15648
    1. Norman J., Fu M., Ekman I., Björck L., and Falk K., “Effects of a mindfulness-based intervention on symptoms and signs in chronic heart failure: A feasibility study,” Eur. J. Cardiovasc. Nurs., 2018, 10.1177/1474515117715843
    1. Espie C. A. et al., “Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial,” 2019, 10.1001/jamapsychiatry.2018.2745
    1. Faul F., Erdfelder E., Lang A. G., and Buchner A., “G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences,” 2007, 10.3758/bf03193146
    1. Morin C. M., Belleville G., Bélanger L., and Ivers H., “The insomnia severity index: Psychometric indicators to detect insomnia cases and evaluate treatment response,” Sleep, 2011, 10.1093/sleep/34.5.601
    1. Huberty J., Green J., Glissmann C., Larkey L., Puzia M., and Lee C., “Efficacy of the mindfulness meditation mobile app ‘calm’ to reduce stress among college students: Randomized controlled trial,” J. Med. Internet Res., 2019, 10.2196/14273
    1. Krupp L. B., Jandorf L., Coyle P. K., and Mendelson W. B., “Sleep disturbance in chronic fatigue syndrome,” J. Psychosom. Res., vol. 37, no. 4, pp. 325–331, 1993. 10.1016/0022-3999(93)90134-2
    1. Krupp L. B., “The Fatigue Severity Scale,” Arch. Neurol., 1989, 10.1001/archneur.1989.00520460115022
    1. Johns M. W., “A new method for measuring daytime sleepiness: The Epworth sleepiness scale,” Sleep, 1991, 10.1093/sleep/14.6.540
    1. Kendzerska T. B., Smith P. M., Brignardello-Petersen R., Leung R. S., and Tomlinson G. A., “Evaluation of the measurement properties of the Epworth sleepiness scale: A systematic review,” Sleep Medicine Reviews. 2014, 10.1016/j.smrv.2013.08.002
    1. Nicassio P. M., Mendlowitz D. R., Fussell J. J., and Petras L., “The phenomenology of the pre-sleep state: the development of the pre-sleep arousal scale,” Behav. Res. Ther., vol. 23, no. 3, pp. 263–271, 1985. 10.1016/0005-7967(85)90004-x
    1. Maich K. H. G., Lachowski A. M., and Carney C. E., “Psychometric Properties of the Consensus Sleep Diary in Those With Insomnia Disorder,” Behav. Sleep Med., 2018, 10.1080/15402002.2016.1173556
    1. Chen J. A., Fearey E., and Smith R. E., “‘that Which Is Measured Improves’: A Theoretical and Empirical Review of Self-monitoring in Self-management and Adaptive Behavior Change,” J. Behav. Ther. Ment. Heal., vol. 1, no. 4, p. 19, 2017.
    1. Mairs L. and Mullan B., “Self-Monitoring vs. Implementation Intentions: a Comparison of Behaviour Change Techniques to Improve Sleep Hygiene and Sleep Outcomes in Students,” Int. J. Behav. Med., 2015, 10.1007/s12529-015-9467-1
    1. McCoy C. E., “Understanding the intention-to-treat principle in randomized controlled trials,” Western Journal of Emergency Medicine. 2017, 10.5811/westjem.2017.8.35985
    1. Cohen J., “Statistical power analysis for the behavioural sciences. Hillside,” NJ: Lawrence Earlbaum Associates. 1988, 10.1111/1467-8721.ep10768783
    1. Raudenbush S. W., Bryk A., Cheong Y. F., and Congdon R., “HLM 8 for Windows.” Scientific Software International, Inc., Skokie, IL, 2019.
    1. Raudenbush S. W., Bryk A. S., and Congdon R., “HLM for windows (version 7),” Comput. software, Lincolnwood, Sci. Softw. Int., 2000.
    1. Feingold A., “Effect Sizes for Growth-Modeling Analysis for Controlled Clinical Trials in the Same Metric as for Classical Analysis,” Psychol. Methods, 2009, 10.1037/a0014699
    1. Nordin Å., Taft C., Lundgren-Nilsson Å., and Dencker A., “Minimal important differences for fatigue patient reported outcome measures—A systematic review,” BMC Medical Research Methodology. 2016, 10.1186/s12874-016-0167-6
    1. Grossman P. et al., “MS quality of life, depression, and fatigue improve after mindfulness training: A randomized trial,” Neurology, 2010, 10.1212/WNL.0b013e3181f4d80d
    1. Surawy C., Roberts J., and Silver A., “The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: A series of exploratory studies,” Behav. Cogn. Psychother., 2005, 10.1017/S135246580400181X
    1. Carlson L. E. and Garland S. N., “Impact of Mindfulness-Based Stress Reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients,” Int. J. Behav. Med., 2005, 10.1207/s15327558ijbm1204_9
    1. Huberty J. et al., “Smartphone-based meditation for myeloproliferative neoplasm patients: Feasibility study to inform future trials,” J. Med. Internet Res., 2019, 10.2196/12662
    1. Huberty J., Eckert R., Larkey L., Joeman L., and Mesa R., “Experiences of using a consumer-based mobile meditation app to improve fatigue in myeloproliferative patients: Qualitative study,” J. Med. Internet Res., 2019, 10.2196/14292
    1. Garland S. N., Zhou E. S., Gonzalez B. D., and Rodriguez N., “The Quest for Mindful Sleep: a Critical Synthesis of the Impact of Mindfulness-Based Interventions for Insomnia,” Current Sleep Medicine Reports. 2016, 10.1007/s40675-016-0050-3
    1. Mrazek A. J. et al., “The future of mindfulness training is digital, and the future is now,” Current Opinion in Psychology. 2019, 10.1016/j.copsyc.2018.11.012
    1. Yu J. S., Kuhn E., Miller K. E., and Taylor K., “Smartphone apps for insomnia: Examining existing apps’ usability and adherence to evidence-based principles for insomnia management,” Transl. Behav. Med., 2019, 10.1093/tbm/iby014
    1. Shin J. C., Kim J., and Grigsby-Toussaint D., “Mobile Phone Interventions for Sleep Disorders and Sleep Quality: Systematic Review,” JMIR mHealth uHealth, 2017, 10.2196/mhealth.7244
    1. Cowie J., Bower J. L., Gonzalez R., and Alfano C. A., “Multimedia Field Test: Digitalizing Better Sleep Using the Sleepio Program,” Cognitive and Behavioral Practice. 2018, 10.1016/j.cbpra.2017.09.005
    1. Lee R. A. and Jung M. E., “Evaluation of an mhealth app (destressify) on university students’ mental health: Pilot trial,” J. Med. Internet Res., 2018, 10.2196/mental.8324
    1. Rung A. L., Oral E., Berghammer L., and Peters E. S., “Feasibility and Acceptability of a Mobile Mindfulness Meditation Intervention Among Women: Intervention Study.,” JMIR mHealth uHealth, 2020. 10.2196/15943
    1. Donker T., Petrie K., Proudfoot J., Clarke J., Birch M. R., and Christensen H., “Smartphones for smarter delivery of mental health programs: A systematic review,” Journal of Medical Internet Research. 2013, 10.2196/jmir.2791
    1. Kuhn E. et al., “CBT-I coach: A description and clinician perceptions of a mobile app for cognitive behavioral therapy for insomnia,” J. Clin. Sleep Med., 2016, 10.5664/jcsm.5700
    1. Soh H. L., Ho R. C., Ho C. S., and Tam W. W., “Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials,” Sleep Med., vol. 75, pp. 315–325, 2020. 10.1016/j.sleep.2020.08.020
    1. Eckert R., Huberty R., Kosiorek J., Clark-Sienkiewicz H., Larkey S, Mesa L., “Remote monitoring of cancer patient participation in a 12-week online study: Challenges and directions for future research.,” J. Meas. Phys. Behav.
    1. Buysse D. J., Reynolds C. F. 3rd, Monk T. H., Berman S. R., and Kupfer D. J., “The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research,” Psychiatry Res., vol. 28, no. 2, pp. 193–213, May 1989, 0165-1781(89)90047-4 [pii]. 10.1016/0165-1781(89)90047-4

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