Clinical effects of mindfulness meditation and cognitive behavioral therapy standardized for insomnia: A protocol for a systematic review and meta-analysis

INTRODUCTION: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of mindfulness meditation and cognitive behavioral therapy programs as a psychological intervention for insomnia disorders. METHODS AND ANALYSIS: We will search the following 11 electronic databases without language or publication status restrictions: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and PsycARTICLES. Furthermore, we will also search 5 Korean-language databases (Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Service System, Korean Medical Database, and Korea Citation Index). The study selection and data extraction will be performed independently by 2 authors. The study quality assessment and evaluation of the quality of evidence for the main findings will be performed independently by 2 authors using the Cochrane tool for assessing risk of bias and predefined criteria (the Grading of Recommendations Assessment, Development, and Evaluation approach). Data synthesis and analysis will be performed using RevMan Version 5.3. Data will be synthesized by either a fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. If any plan for documenting important protocol amendments changes, the researchers will have a revision agreement and then register the modification in the International Prospective Register of Systematic Reviews (PROSPERO). ETHICS AND DISSEMINATION: Ethical approval will not be required because individual patient data are not included and because this protocol is for a systematic review. The findings of this systematic review will be disseminated through conference presentations. PROSPERO registration number: CRD42018111217.