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.

Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE

Original Publication: [London] : BMJ Publishing Group Ltd, 2011-

Emotions/*physiology ; Inflammation/*blood ; Mindfulness/*methods ; NF-kappa B/*blood ; Sleep/*physiology ; Sleep Initiation and Maintenance Disorders/*therapy; Adolescent ; Adult ; China ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Polysomnography ; Prospective Studies ; Single-Blind Method ; Sleep Initiation and Maintenance Disorders/blood ; Sleep Initiation and Maintenance Disorders/physiopathology ; Treatment Outcome ; Young Adult

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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

J Clin Oncol. 2014 Feb 10;32(5):449-57. (PMID: 24395850)
Integr Cancer Ther. 2015 Jul;14(4):366-80. (PMID: 25873295)
Altern Ther Health Med. 2014 May-Jun;20(3):37-46. (PMID: 24755569)
Biol Psychiatry. 2015 Nov 15;78(10):721-9. (PMID: 25748580)
BMC Complement Altern Med. 2014 Feb 10;14:50. (PMID: 24512477)
Explore (NY). 2015 May-Jun;11(3):180-5. (PMID: 25843539)
Curr Sleep Med Rep. 2016 Sep;2(3):142-151. (PMID: 28191449)
Front Immunol. 2017 Jun 16;8:670. (PMID: 28670311)
Psychotherapy (Chic). 2011 Jun;48(2):198-208. (PMID: 21639664)
Lancet. 2012 Mar 24;379(9821):1129-41. (PMID: 22265700)
J Altern Complement Med. 2017 Mar;23(3):188-195. (PMID: 28029852)
J Natl Cancer Inst Monogr. 2014 Nov;2014(50):295-301. (PMID: 25749595)
Annu Rev Psychol. 2015 Jan 3;66:143-72. (PMID: 25061767)
Arch Gen Psychiatry. 1961 Jun;4:561-71. (PMID: 13688369)
Evid Based Complement Alternat Med. 2019 Feb 13;2019:9359807. (PMID: 30894878)
Am J Med. 2006 Jun;119(6):463-9. (PMID: 16750956)
JAMA. 2009 May 20;301(19):2005-15. (PMID: 19454639)
Psychother Res. 2008 Nov;18(6):735-42. (PMID: 18815948)
Sci Rep. 2017 Mar 06;7:43690. (PMID: 28262807)
Explore (NY). 2016 Mar-Apr;12(2):90-9. (PMID: 26778081)
Sleep. 2011 Sep 01;34(9):1161-71. (PMID: 21886353)
Brain Behav Immun. 2010 Jan;24(1):54-7. (PMID: 19520155)
Am J Epidemiol. 2013 Sep 15;178(6):956-61. (PMID: 23801012)
PLoS One. 2017 Feb 24;12(2):e0170772. (PMID: 28234940)
J Am Geriatr Soc. 2004 Jun;52(6):892-900. (PMID: 15161452)
Sleep Med Rev. 2004 Feb;8(1):47-62. (PMID: 15062210)
JAMA Intern Med. 2015 Apr;175(4):494-501. (PMID: 25686304)
Contemp Clin Trials. 2014 Sep;39(1):22-7. (PMID: 24993561)
Arch Intern Med. 2006 Sep 18;166(16):1756-62. (PMID: 16983055)
Ann Intern Med. 2016 Jul 19;165(2):125-33. (PMID: 27136449)
Psychother Psychosom. 2012;81(5):296-304. (PMID: 22832540)
Explore (NY). 2011 Mar-Apr;7(2):76-87. (PMID: 21397868)
Menopause. 2012 Feb;19(2):186-93. (PMID: 22048261)
J Psychopharmacol. 2010 Nov;24(11):1577-601. (PMID: 20813762)
Sleep. 2014 Sep 01;37(9):1553-63. (PMID: 25142566)
Sleep. 2008 Jul;31(7):1001-8. (PMID: 18652095)
Nutr Rev. 2007 Dec;65(12 Pt 2):S244-52. (PMID: 18240557)

Keywords: NF-KB; Tai Chi; insomnia; mindfulness; mindfulness meditation

ClinicalTrials.gov NCT03268629

0 (NF-kappa B)

Date Created: 20190713 Date Completed: 20200706 Latest Revision: 20200706

20240628

PMC6624060

10.1136/bmjopen-2018-027061

31296508