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
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/7/e027061.full |
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| author | Chen Pan Xiang Wang Yunlong Deng Peihuan Li Yanhui Liao Xin Ma Guo-Ping Yang Lisha Dai Qiuping Tang |
| author_facet | Chen Pan Xiang Wang Yunlong Deng Peihuan Li Yanhui Liao Xin Ma Guo-Ping Yang Lisha Dai Qiuping Tang |
| author_sort | Chen Pan |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c4312ef5fc8748f8ba57da11011d7c5a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c4312ef5fc8748f8ba57da11011d7c5a2024-11-28T00:30:08ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-027061Efficacy 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 ChinaChen Pan0Xiang Wang1Yunlong Deng2Peihuan Li3Yanhui Liao4Xin Ma5Guo-Ping Yang6Lisha Dai7Qiuping Tang8Department of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Intensive Care Unit, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, Jiangsu Province, ChinaDepartment of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaDepartment of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaNational Clinical Research Center on Mental Disorders and National Technology Institute on Mental Disorders. Hunan Key Laboratory of Psychiatry and Mental Health, the Second Xiangya Hospital, Central South University, Changsha, Hunan, ChinaDepartment of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaCenter of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaDepartment of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaDepartment of Clinical Psychology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, ChinaIntroduction 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.https://bmjopen.bmj.com/content/9/7/e027061.full |
| spellingShingle | Chen Pan Xiang Wang Yunlong Deng Peihuan Li Yanhui Liao Xin Ma Guo-Ping Yang Lisha Dai Qiuping Tang 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/7/e027061.full |
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