'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial.
Study Goal
The researchers aimed to evaluate the effectiveness of a mobile-based mindfulness intervention (MLWI) compared to mobile-based cognitive behavioral therapy (CBT-I) in treating insomnia.
Results Summary
The study will assess sleep quality, insomnia severity, and sleep activity as primary outcomes, along with stress, anxiety, depression, and mindfulness as secondary outcomes. Results will be measured at baseline, post-intervention, and 3-month follow-up, but specific findings are not yet reported in the abstract.
Population
250 participants with insomnia.
Effective Dosage
12 sessions (2 sessions per week, 30 minutes each) over 6 weeks.
Duration
6 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-based interventions (MBIs) | decrease | insomnia | - | - | have proven beneficial | #1 |
mobile or online-based (mHealth) MBIs | no change | effect | - | - | requires further verification | #2 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | sleep quality | participants | - | will evaluate the effectiveness | #3 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | severity of insomnia symptoms | participants | - | will evaluate the effectiveness | #4 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | sleep activity | participants | - | will evaluate the effectiveness | #5 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | perceived stress | participants | - | will evaluate the effectiveness | #6 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | anxiety | participants | - | will evaluate the effectiveness | #7 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | depression | participants | - | will evaluate the effectiveness | #8 |
mHealth MBI, 'Mindful Living with Insomnia' (MLWI) | neutral | mindfulness | participants | - | will evaluate the effectiveness | #9 |
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, χ 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.