Effects of an Online Mindful Living With Challenge (MLWC) Intervention on Mental Health and Quality of Life Among COVID-19 Patients in China: A Protocol of a Randomized Controlled Trial (preprint)

ABSTRACT

Background COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety, especially for patients with COVID-19. Studies suggest that mindfulness-based intervention is an effective, easily delivered and non-aggressive online therapy for patients with mental disorders. This study aims to explore the efficacy and possible mechanism of a Mindful Living With Challenge (MLWC) intervention designed for Chinese COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic.Methods This study is a protocol for a randomized controlled trial. More than 1600 eligible participants will be assigned 11 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 primary outcome is mental health status which includes PTSD and other psychological symptoms (i.e. depression, anxiety). The secondary outcomes are related physical symptoms including fatigue and sleeplessness assessed by verified scales such as the Fatigue Scale-14, Pittsburgh Sleep Quality Index. In addition, Five Facets Mindfulness Questionnaire, the Nonattachment Scale, the Stillness Scale, the Resilience Style Questionnaire and the Social Support Scale will be used to assess the mindfulness, stillness, nonattachment level, resilience and perceived social support before and after the intervention, which may be the possible mediators and moderators of the link between the MLWC intervention and target outcomes. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis.Discussion This study will provide scientific evidence on the efficacy and possible mechanism of the MLWC intervention in improving the quality of life and psychological status among COVID-19 survivors in China. Findings from this study will contribute to a growing research field that assesses the effectiveness of mobile-based and theoretically guided interventions for improving the psychological status of the COVID-19 survivors. Moreover, findings from this study will also contribute to the prevention and management of the psychological complications patients face 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.