Evaluating an Online Mindfulness-Based Intervention for Insomnia

Insomnia, Primary Clinical Trial

Official title: Evaluating an Online Mindfulness-Based Intervention for Individuals With Insomnia in China: A Randomized Controlled Trial

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. ;

Related Conditions & MeSH terms

• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

• 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