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'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial.

BMJ open
January 1, 1970
Chen Pan et al. (13 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, N.I.H., ExtramuralResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

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.

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
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, 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.

Medical Subject Headings (MeSH)
Cognitive Behavioral TherapyHumansMindfulnessQuality of LifeRandomized Controlled Trials as TopicSleep Initiation and Maintenance DisordersTelemedicineTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations3
Citations/Year1.0
Relative Citation Ratio0.39
NIH Percentile21.2%
Research Impact Scores
APT Score0.50
Weight Score1.58
Normalized Score0.67
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