Ming-Yu Si1, Wei-Jun Xiao1, Chen Pan2, Hao Wang1, Yi-Man Huang1, Jun Lian1, Winnie W S Mak3, Zhi-Wei Leng1, Xiao-You Su4, Qiu-Ping Tang5, Yu Jiang1, Lu-Zhao Feng6, Wei-Zhong Yang1, Chen Wang1,7,8. 1. School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, 9 DongDanSanTiao, Dongcheng, Beijing, China. 2. Department of Clinical Psychology, The Third Xiangya Hospital of Central South University, No. 138 Tongzipo Road, Yuelu, Changsha, Hunan, China. 3. Diversity and Well-Being Laboratory, Department of Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China. 4. School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, 9 DongDanSanTiao, Dongcheng, Beijing, China. suxiaoyou@hotmail.com. 5. Department of Clinical Psychology, The Third Xiangya Hospital of Central South University, No. 138 Tongzipo Road, Yuelu, Changsha, Hunan, China. tt96@sina.com. 6. School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, 9 DongDanSanTiao, Dongcheng, Beijing, China. fengluzhao@cams.cn. 7. Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 8. National Clinical Research Center for Respiratory Diseases, Beijing, China.
Abstract
BACKGROUND: COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety among patients with COVID-19. Based on the previous mindfulness-based interventions proved to be effective, this protocol reports a design of a randomized controlled trial aiming to explore the efficacy and possible mechanism of a mindful living with challenge (MLWC) intervention developed for COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic. METHODS: In April 2021, more than 1600 eligible participants from Hubei Province of China will be assigned 1:1 to an online MLWC intervention group or a waitlist control group. All participants will be asked to complete online questionnaires at baseline, post-program, and 3-month follow-up. The differences of mental health status (e.g. PTSD) and physical symptoms including fatigue and sleeplessness between the COVID-19 survivors who receiving the online MLWC intervention and the control group will be assessed. In addition, the possible mediators and moderators of the link between the MLWC intervention and target outcomes will be evaluated by related verified scales, such as the Five Facets Mindfulness Questionnaire. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis. DISCUSSION: The efficacy and potential mechanism of MLWC intervention in improving the quality of life and psychological status of COVID-19 survivors in China are expected to be reported. Findings from this study will shed light on a novel and feasible model in improving the psychological well-being of people during such public health emergencies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000037524; Registered on August 29, 2020, http://www.chictr.org.cn/showproj.aspx?proj=60034 .
RCT Entities:
BACKGROUND:COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety among patients with COVID-19. Based on the previous mindfulness-based interventions proved to be effective, this protocol reports a design of a randomized controlled trial aiming to explore the efficacy and possible mechanism of a mindful living with challenge (MLWC) intervention developed for COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic. METHODS: In April 2021, more than 1600 eligible participants from Hubei Province of China will be assigned 1:1 to an online MLWC intervention group or a waitlist control group. All participants will be asked to complete online questionnaires at baseline, post-program, and 3-month follow-up. The differences of mental health status (e.g. PTSD) and physical symptoms including fatigue and sleeplessness between the COVID-19 survivors who receiving the online MLWC intervention and the control group will be assessed. In addition, the possible mediators and moderators of the link between the MLWC intervention and target outcomes will be evaluated by related verified scales, such as the Five Facets Mindfulness Questionnaire. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis. DISCUSSION: The efficacy and potential mechanism of MLWC intervention in improving the quality of life and psychological status of COVID-19 survivors in China are expected to be reported. Findings from this study will shed light on a novel and feasible model in improving the psychological well-being of people during such public health emergencies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000037524; Registered on August 29, 2020, http://www.chictr.org.cn/showproj.aspx?proj=60034 .
Authors: Wanqiu Tan; Fengyi Hao; Roger S McIntyre; Li Jiang; Xiaojiang Jiang; Ling Zhang; Xinling Zhao; Yiran Zou; Yirong Hu; Xi Luo; Zhisong Zhang; Andre Lai; Roger Ho; Bach Tran; Cyrus Ho; Wilson Tam Journal: Brain Behav Immun Date: 2020-04-23 Impact factor: 7.217
Authors: Clara Paz; Guido Mascialino; Lila Adana-Díaz; Alberto Rodríguez-Lorenzana; Katherine Simbaña-Rivera; Lenin Gómez-Barreno; Maritza Troya; María Ignacia Paez; Javier Cárdenas; Rebekka M Gerstner; Esteban Ortiz-Prado Journal: PLoS One Date: 2020-09-30 Impact factor: 3.240