Randomized Controlled Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Mar 15, 2021; 12(3): 292-305
Published online Mar 15, 2021. doi: 10.4239/wjd.v12.i3.292
Effectiveness of cognitive behavior therapy for sleep disturbance and glycemic control in persons with type 2 diabetes mellitus: A community-based randomized controlled trial in China
Huai-Zhong Zhang, Pan Zhang, Gui-Qiu Chang, Quan-Yong Xiang, Huan Cao, Jin-Yi Zhou, Zong-Mei Dong, Cheng Qiao, Chun-Rong Xu, Yu Qin, Pei-An Lou
Huai-Zhong Zhang, Huan Cao, Chun-Rong Xu, Department of Psychiatry, Xuzhou Third People’s Hospital, Xuzhou 221000, Jiangsu Province, China
Pan Zhang, Gui-Qiu Chang, Zong-Mei Dong, Cheng Qiao, Pei-An Lou, Department of Control and Prevention of Chronic Non-communicable Diseases, Xuzhou Center for Disease Control and Prevention, Xuzhou 221006, Jiangsu Province, China
Quan-Yong Xiang, Jin-Yi Zhou, Yu Qin, Department of Control and Prevention of Chronic Non-communicable Diseases, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu Province, China
Pei-An Lou, Department of Epidemiology and Health Statistics, Xuzhou Medical University, Xuzhou 221006, Jiangsu Province, China
Author contributions: Zhang HZ and Zhang P conceived and designed the study, collected and analyzed the data, and drafted and reviewed the manuscript; Chang GQ conceived and designed the study, analyzed the data, reviewed the manuscript, and contributed to the Introduction; Xiang QY and Cao H collected and analyzed the data, reviewed the manuscript, and provided administrative support; Zhou JY was responsible for the conception and design of the study, collected the data, reviewed the manuscript, and supervised the study; Dong ZM conceived and designed the study, analyzed the data, and reviewed the manuscript; Qiao C and Xu CR collected the data, contributed to the discussion, and reviewed the manuscript; Qin Y and Lou PA conceived and designed the study, collected and analyzed the data, drafted and reviewed the manuscript, obtained funding, provided administrative support, and supervised the study; Lou PA reviewed and edited the manuscript and is the guarantor of this work. As such, Lou PA had full access to all the study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Supported by The Preventive Medicine Research Projects of Jiangsu Province Health Department, No. Y2015010 and No. Y2018016; The Science and Technology projects of Xuzhou city, No. KC15SM046; the Youth Medical Talent Project of “ Ke Jiao Qiang Wei Projects” in Jiangsu Province, No. QNRC2016375.
Institutional review board statement: The current study was conducted under protocols approved by Xuzhou Center for Disease Control and Prevention and the Xuzhou of Medical Sciences Ethics Committee (Approval No. 20151210).
Clinical trial registration statement: The trial was registered in the Chinese Clinical Trials Registry on March 3, 2016 (reference: ChiCTR-IOP-16008045) and implemented according to the 2000 revised version of the Helsinki Declaration.
Informed consent statement: Written informed consent was obtained from all participants.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article are reported.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The author has read the CONSORT Statement-checklist of items, and the manuscript was prepared and revised according to the CONSORT Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Pei-An Lou, Professor, Department of Control and Prevention of Chronic Non-communicable Diseases, Xuzhou Center for Disease Control and Prevention, No. 142 West Erhuan Road, Xuzhou 221006, Jiangsu Province, China. lpa82835415@126.com
Received: September 18, 2020
Peer-review started: September 18, 2020
First decision: December 1, 2020
Revised: December 9, 2020
Accepted: December 23, 2020
Article in press: December 23, 2020
Published online: March 15, 2021
Processing time: 165 Days and 4.9 Hours
Core Tip

Core Tip: Cognitive behavior therapy is recommended as the preferential intervention for insomnia. Cognitive behavior therapy could reduce hemoglobin A1c values at 6 mo and 12 mo following improved subjective sleep disturbance of patients with type 2 diabetes mellitus in the community-based randomized controlled trial. Cognitive behavior therapy should be included in the comprehensive management of diabetes and applied in community by general practitioners.