'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial.
Chen Pan, Bingyu Tie, Weichao Yuwen, Xiaoyou Su, Yunlong Deng, Xin Ma, Yan Wu, Yanhui Liao, Luya Kong, Yutao Zhang, Ziwan Li, Qinghua Pan, Qiuping Tang
BMJ Open February 15, 2022 DOI: 10.1136/bmjopen-2021-053501 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Sample size | 250 |
| Population | Adults with insomnia recruited in China |
| Duration | 6-week intervention (12 sessions), with follow-up at 3 months |
| Measures | Pittsburgh Sleep Quality Index, Insomnia Severity Index, Mi Smart Band sleep tracker |
| Topics | Meditation |
| Keywords | Humans Treatment outcome Telemedicine Quality of life Cognitive behavioral therapy Information technology Sleep medicine Protocols & guidelines |
| Registration | NCT04806009 |
| Key findings | The protocol proposes a two-arm randomized trial comparing a mobile mindfulness-based intervention ('Mindful Living with Insomnia') with mobile cognitive behavioral therapy for insomnia in 250 participants. It aims to determine whether the mindfulness program is effective for sleep quality, insomnia severity, and sleep activity, with secondary outcomes of stress, anxiety, depression, and mindfulness; no results are reported. |
Abstract
Introduction: Insomnia has a remarkably negative effect on the work, quality of life and psychosomatic health of individuals, and imposes a substantial economic burden on society. Mindfulness-based interventions (MBIs) have proven beneficial in the treatment of insomnia. However, the effect of mobile or online-based (mHealth) MBIs requires further verification. This study will evaluate the effectiveness of an mHealth MBI, 'Mindful Living with Insomnia' (MLWI), relative to that of mHealth cognitive behavioural therapy for insomnia (CBT-I). Methods and analysis: The study is an mHealth, randomised controlled trial. Two hundred and fifty participants will be allocated randomly and equally to either the MLWI or CBT-I group. The intervention will involve 12 sessions over a 6-week course, with 2, 30 min sessions per week. The primary outcomes are sleep quality, severity of insomnia symptoms and sleep activity, according to the Pittsburgh Sleep Quality Index, Insomnia Severity Index and sleep tracker Mi Smart Band, respectively. The secondary outcomes are perceived stress, anxiety, depression and mindfulness. Outcomes will be evaluated at the baseline, end of the intervention period and at the 3-month follow-up. Data analyses will include covariance, regression analysis, χ2, t-test and Pearson's correlations. Participants will be recruited from January to June 2022, or until the recruitment process is complete. The follow-up will be completed in December 2022. All trial results should be available by the end of December 2022. Ethics and dissemination: Full approval for this study has been obtained from the Ethics Committee at The Third Xiangya Hospital, Central South University, Changsha, China (21010). Study results will be disseminated via social media and peer-reviewed publications. Trial registration number: NCT04806009.
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
Cites 15
- 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
- A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia Sleep August 29, 2014
- Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial PLoS One January 7, 2021
- Effects of mindfulness-based stress reduction on sleep quality and mental health for insomnia patients: A meta-analysis. Journal of Psychosomatic Research May 21, 2020
and 10 more in the library