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Study Protocol
Xiaoyou Su
CAMS PUMC: Chinese Academy of Medical Sciences and Peking Union Medical College
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4216-2142
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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 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 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.
Keywords
COVID-19, online, mindfulness-based intervention, mental health, RCT, China
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CURRENT STATUS: Under Review
Version 1
Posted 03 Dec, 2020
No community comments so far
Review #3 received
Received 19 Dec, 2020
Editorial decision: Major revision
On 19 Dec, 2020
Review #1 received
Received 08 Dec, 2020
Reviewer #3 agreed
On 04 Dec, 2020
Review #2 received
Received 30 Nov, 2020
Reviewer #2 agreed
On 29 Nov, 2020
Reviewers invited
Invitations sent on 26 Nov, 2020
Reviewer #1 agreed
On 26 Nov, 2020
Editor assigned
On 25 Nov, 2020
Submission checks complete
On 25 Nov, 2020
Editor invited
On 25 Nov, 2020
First submitted
On 22 Nov, 2020
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Subject Areas
Infectious Diseases
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A new preprint design is coming!
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This preprint is under consideration at Infectious Diseases of Poverty. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study Protocol
Xiaoyou Su
CAMS PUMC: Chinese Academy of Medical Sciences and Peking Union Medical College
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4216-2142
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 03 Dec, 2020
No community comments so far
Review #3 received
Received 19 Dec, 2020
Editorial decision: Major revision
On 19 Dec, 2020
Review #1 received
Received 08 Dec, 2020
Reviewer #3 agreed
On 04 Dec, 2020
Review #2 received
Received 30 Nov, 2020
Reviewer #2 agreed
On 29 Nov, 2020
Reviewers invited
Invitations sent on 26 Nov, 2020
Reviewer #1 agreed
On 26 Nov, 2020
Editor assigned
On 25 Nov, 2020
Submission checks complete
On 25 Nov, 2020
Editor invited
On 25 Nov, 2020
First submitted
On 22 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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 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 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.
Figure 1
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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