Evaluating an Online Mindfulness-Based Intervention for Insomnia

Status Not yet recruiting

Clinical Trial Summary

Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

Clinical Trial Description

This will be an online based, randomized, controlled trial. Investigators will recruit 1000 participants, and will randomize and allocate participants 1:1 to the 'Mindful Living With Insomnia (MLWI)' group (n=500) and the 'CBT-I' group (n=500). The Intervention will involve 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. The primary outcome will be sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia symptoms assessed by the Insomnia Severity Index (ISI), and sleep parameters recorded using Mi Smart Band. The secondary outcomes include perceived stress, anxiety, depression, and mindfulness. Outcomes will be evaluated at baseline, the end of the intervention period, and at a 3-month follow-up. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson's correlations will be applied in data analysis. ;

Study Design

Related Conditions & MeSH terms

Insomnia, Primary
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT04806009
Study type	Interventional
Source	Central South University
Contact	Chen Pan, Dr
Phone	86-0731-88618487
Email	758933968@qq.com
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2022
Completion date	March 31, 2023

View Details

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