Efficacy of mindfulness-based intervention ('mindfulness-based joyful sleep') in young and middle-aged individuals with insomnia using a biomarker of inflammatory responses: a prospective protocol of a randomised controlled trial in China.
Study Goal
The researchers aimed to compare the effectiveness of mindfulness-based joyful sleep (MBI) to cognitive behavioral therapy for insomnia (CBT-I) in young and middle-aged individuals with insomnia disorder and explore its effect on inflammatory markers (NF-κB).
Results Summary
The study protocol suggests that MBIs may be effective in treating insomnia and reducing inflammatory markers, but results are pending as the trial is pre-results. The primary outcomes include sleep quality and insomnia severity, while secondary outcomes assess stress, anxiety, and depression.
Population
Young and middle-aged individuals with insomnia disorder.
Effective Dosage
2-hour sessions weekly for 8 weeks.
Duration
8 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
mindfulness-based interventions (MBIs) | decrease | insomnia | older individuals with insomnia | - | are effective in insomnia treatment | #1 |
mindfulness-based interventions (MBIs) | decrease | inflammatory markers level | older individuals with insomnia | - | can reduce inflammatory markers level | #2 |
cognitive behavioural therapy for insomnia (CBT-I) | decrease | insomnia | - | - | was recommended as the preferred non-pharmacological treatment | #3 |
INTRODUCTION: Insomnia is a prevalent and significant public health concern. Insomnia can lead to increased inflammatory markers associated with chronic diseases such as cardiovascular disease, diabetes and cancer. Studies suggest that mindfulness-based interventions (MBIs) are more easily delivered within the community than cognitive behavioural therapy for insomnia (CBT-I) which was recommended as the preferred non-pharmacological treatment by the American Academy of Sleep Medicine, are effective in insomnia treatment and can reduce inflammatory markers level in older individuals with insomnia. This study aims to compare the effectiveness of an MBI to CBT-I in young and middle-aged individuals with insomnia disorder and explore its effect on nuclear factor kappa B (NF-κB), a transcription factor that controls the expression of genes involved in inflammation. METHODS AND ANALYSIS: This report describes a protocol for a randomised controlled trial. Seventy eligible participants will be assigned to mindfulness-based joyful sleep or CBT-I for 2-hour sessions weekly for 8 weeks. The primary outcome is sleep quality assessed by the Pittsburgh Sleep Quality Index, severity of insomnia symptoms assessed by the Insomnia Severity Index and sleep parameters recorded using sleep diary and polysomnography. Secondary outcomes include perceived stress, anxiety and depression. The exploratory outcome is serum level of NF-κB. Outcomes will be evaluated at baseline, the end of the ntervention period and at a 3 month follow-up. Data will be analysed using general linear models, specifically analysis of covariance and analysis of variance will be used. ETHICS AND DISSEMINATION: Full ethical approval for this study has been obtained from the Ethics Committee of the Third Xiangya Hospital, Central South University, Changsha, China (2018-S236). If Mindfulness-Based Joyful Sleep is proven effective, its dissemination will help bridge the gap between the unmet need and the demand for insomnia interventions in China. TRIAL REGISTRATION NUMBER: NCT03268629; Pre-results.