Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial
Phase: NA
Conditions: Stress, Psychological
Sponsor: Imam Abdulrahman Bin Faisal University

 
 
 
 
 
 
      
Brief Mindfulness based Intervention 
Compared toPsychoeducation for Front-
Line Medical Staff in theCOVID19 
Pandemic to Improve Psychological 
Wellbeing, aRandomized Controlled 
Multicenter Trial. 
      
      

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Introduction 
Coronavirus Disease 2019 is declared as the undetectable adversary, the messenger of 
death, a determined and heartless assailant that has infected millions of people worldwide with a 
possibly deadly illness. COVID-19 is a quickly spreading novel infection that spread between 
people through coughing, sneezing, and contaminated surfaces. An occurrence of the infection 
was0020pronounced by WHO on the 30th of January and as of 23th of June, more than 9 million 
infected cases were announced with 474.000 losses of life around the world ("European Centre 
for Disease Prevention and Control," 2020). Coronavirus pandemic is a challenge to the health 
care system and a disaster to both individuals and institutions. Anxiety and fear have been 
created by this pandemic among health care providers from physicians to nurses. Unluckily, it 
has been seen that there is a high risk of the negative effects of stress in health care respondents 
(Brooks et al., 2011). 
Health care worker mental wellbeing protection is of prime importance who look after patients 
with COVID-19 for the long-lasting ability of health workers (Organization, 2020). 
Specifically, giving psychological care to frontline health care workers is an important challenge 
in the upcoming days and months (Kluge, 2020).  
In pandemics depression, anxiety, and stress seen as emotional reactions. Frontline health care 
staff in china looking after patients of COVID-19 are seen with insomnia, stress, and anxiety and 
had more severe mental health problems than those in lesser roles (Lai et al., 2020; Lu et al., 
2020; Zhang et al., 2020). 
On the contrary, a higher prevalence of psychological sufferings has been reported by some 
studies in non-front line health care workers, might be these health care workers have less 
approach to physiological support and important information (Tan et al., 2020). This is the 

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reason support mechanisms are required for all health care staff regardless of their job 
description and level of exposure to the virus. 
Awareness of the existing moment and recognition of thoughts and emotions devoid of judgment 
is known as mindfulness (Kabat-Zinn, 1990). Mindfulness-based interventions (MBIs) are 
generally short-term interventions (normally eight sessions) carried in a group setting, which 
include mindfulness meditation training and ethics. Mindfulness-Based Stress Reduction 
(MBSR) (Kabat-Zinn, 1990) and Mindfulness-Based Cognitive Therapy (MBCT) (Segal et al., 
2002) are the most commonly calculated and available methods. Previous researches propose 
that mindfulness is linked with an acceptance attitude (Bishop et al., 2004). Therefore, people 
with great levels of mindfulness are less likely to be overcome by the painful emotions such as 
depression (Carmody & Baer, 2008; Barnes & Lynn, 2010; Alzahrani et al., 2020) and anxiety 
(Belen, 2020; Singh et al., 2020). A vast number of studies in support acknowledged that person 
levels of depression (Zemestani & Nikoo, 2019) and anxiety symptoms (La Torre et al., 2020) 
are reduced by mindfulness training and sessions. 
Mindfulness training has been connected with a curiosity attitude, association to self and patient, 
listening attentively, recognition of error, and clinical understanding (Epstein, 1999). Specific 
mindful exercise has thus been provided as a technique to strengthen medical decision-making, 
be it suitability of antibiotic treatment (Vaughn & Flanders, 2016), indwelling urinary 
catheters,(Kiyoshi-Teo et al., 2013) or worker results, such as work commitment (Leroy et al., 
2013) and performance of the job (Dane & Brummel, 2014). It is not astonishing then, that 
combined mindfulness is a trademark of organizations with high reliability (Sutcliffe et al., 2016) 
and also lower turnover rates, improved safety, and quality are related to it (Vogus et al., 2014).  

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A significant obstacle to extensive execution of mindfulness in health care sites is the time 
needed for exercise and training. Mindfulness ranges from eating mindfully (i.e., eating slowly, 
savoring each morsel) to multi-hour meditation training, where the attention is on emotional state 
and breathing (Khoury et al., 2013). As for backing to psychological well-being, mindfulness is 
an important concept in the course of the period of an emergency, such as the COVID-19 
pandemic. Mindfulness is measured as focused attention on solid experience in the current 
moment (Svendsen et al., 2017). On the contrary, fear of COVID-19 is placed soon of getting the 
virus or losing their beloved ones from this horrific disease. In his aspect, mindfulness may 
counter the negative effect of anxiety and fear linked with COVID-19 and improve the person’s 
mental health. Furthermore, immediate research priorities newly are to probe the constructs that 
will update interventions to manage with COVID-19 anxiety and fear that will shrink mental 
health problems rates like depression and anxiety (Holmes et al., 2020)  
To our knowledge this is the first psychological intervention study done in the age of COVID19 
pandemic to front-line medical staff in the COVID19 Pandemic, our aim is to evaluate the 
effectiveness of brief mindfulness based interventions in frontline HCP to cope for (COVID19). 
Our specific objectives are: To measure frontline HCP’s level of anxiety, resilience, and how 
mindfulness based interventions affect anxiety and psychological resilience of HCP. 
                                                   Materials and Methodology 
Design 
Parallel randomized controlled clinical trial. 1:1 intervention to control group. 
Settings and Participants 
This randomized clinical trial is a multicenter trial on COVID19 frontline health care 
professionals, namely physicians, nurses and respiratory therapist. 

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The trial will be conducted virtually using mp3 audios and pre/ post trial electronic 
questionnaires that will be delivered and tracked through a customized website for this purpose. 
The 2 largest Eastern province hospitals are involved in the trial; 
King Fahad Hospital of Imam Abdulrahman bin Faisal University and Qatif Central Hospital 
Recruitment of study participants will be through their hospitals’ human resources department. 
From the date of IRB approval to mid of June, 2020. 
Outcome will be assessed once for a 4 week period, comprising a 2-week intervention interval 
and a 2-week follow-up period. 
 
Information technology and Cybersecrity 
For the sack of this study a new system was developed to be used for data collection. The system 
was designed as an electronic questioner with audio clips that is sent automatically to the 
participants’ email and phones, where each participant receives their own special link. The 
system was also designed to send daily reminders if the participant for the duration of the study. 
Once a participant clicks on the link they will be taken to their own site where they can listen to 
the audio file dedicated for them and fill the survey created for them. They system was designed 
to have a different site for admins (authors of this paper) with a dashboard that allowed them to 
create, edit, and control participants, groups, and hospitals. It also allowed them to track the 
participants’ adherent to the study by frequency and duration. The admin site also allowed them 
to easily download the collected data an excel file, to be imported to SPSS later. 
This system was built as a cloud service that can be accessed from anywhere with the right 
credentials. The authors choose the domain ‘CPWR2020.com’ to be the address for this cloud 
system. To be sure that the collected data is protected and safe, a proper penetration testing and 

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vulnerability assessment was done on the system and the website. A cybersecurity expert 
performed the testing using advanced tools such as GreenBone. All tests are done after getting 
the proper consent.  
The website was first assessed using the GreenBone Vulnerability Assessment System. The IP 
address of the server was configured in GeenBone and it was customized to check certain 
scenarios on the tested server depending on the requirement and specification for the assessment. 
Keeping in mind to that the server needs to be kept alive during the assessment and not to hinder 
the server availability to other users. The server was tested for all known TCP and UDP ports. 
Port scanning is one of the important factors to make sure the server is posing a good security 
posture as ports act as opening gates to adversaries. After testing the website, the results were 
checked for false positives using common tools such as clicking on a crawled link from the 
assessment report. The firewall has to be configured to allow the ongoing traffic from the 
vulnerability assessment server to reach the server which resides outside the testing server 
network. The traffic generated by the vulnerability scanner mimics those of real attacks. The 
final report of the testing showed that there is no threats and that the system is safe to be used, 
and the collected data will be safe. 
 
 
 
 
 
 
 

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Sunday, December 6, 2020 
Interventions 
Brief Mindfulness-Based Interventions have become popular after time commitment challenges 
for the traditional mindfulness meditation. Brief mindfulness interventions may be effective in 
improving health care providers` well-being and can impact numerous health related outcomes. 
(Gilmartin et al., 2017; Howarth et al., 2019) 
Intervention group: brief mindfulness-based audio recording 
Participants in the intervention group will be given an mp3 audio recording of a 20-minute 
mindfulness will be download directly to a personal device of their choice, such as a smart 
phone. 
The 20 minute daily mindfulness sessions for 2 weeks consist of the following guided meditation 
practices: 1. Bring your attention to a primary object of focus, e.g. your breath. 2. Maintain a 
momentto-moment awareness, e.g., the feeling of your breath entering and exiting the body. 3. 
When your mind naturally drifts into thinking (mind wandering); just notice you are thinking, 
and then bring your attention back to your object of focus, e.g. your breath. 4. When a strong 
sensation or emotion arises, again, notice the sensation or emotion and return to your breath. 5. 
As you gain confidence, you may practice maintaining this focus while observing thoughts 
flowing through your mind or sensations in your body while showing no concern for the content; 
you may practice this anytime throughout your day. 6. You may even label your thoughts, i.e., 
thinking, planning, worrying, or your feelings, i.e., anger, fear, love, anxiety, etc., or your body 
sensations, i.e., hot, cold, sharp, tight, tingly. At any point you may shift your attention back to 
your breath or object of focus while still being aware of your thoughts and feelings. 7. Thank 
yourself for your efforts and for taking this time. (Howarth et al., 2016) 
Control group: 

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Control group will be given an mp3 audio recording of a 20-minutes of progressive muscle 
relaxation will be download directly to a personal device of their choice, such as a smart phone. 
The 20-minute daily sessions of the progressive muscle relaxation for 2 weeks involves tensing 
up a group of muscles so that they are as tightly contracted as possible , holding them in a state 
of tension for few seconds , and then relaxing the muscle . 
Both the intervention and control group will receive the same follow-up and frequency of 
sessions, time matched. Sessions will be provided virtually for home practice through Emails and 
SMS messages with Smart-phones coaching support for settings of intervention guide. 
 
Outcomes 
Primary outcomes are reduction of anxiety symptom severity assessed using the (state trait 
anxiety–7 Item Scale) and change in the level of psychological resilience assessed using the 
(Connor-Davidson Resilience Scale (CD-RISC)). 
Secondary outcomes are factors associated with mental wellbeing, correlation between anxiety 
and psychological resilience, and functional status (12-Item Short Form 
Survey). 
Sampling technique and sample size: 
All COVID19 frontline physicians, nurses and respiratory therapists working at the hospitals 
under investigation - during the study period will be approached about the study aim through 
their human resources departments, the ones who accept to participate will be enrolled. 
Exclusion criteria: 
1- History of psychotic disorder, 
2- Substance abuse or dependence within the last 6 months 

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Sunday, December 6, 2020 
3- Current severe neurotic disorder, severe depression or severe anxiety. 
4-Concurrent psychotherapy.  
5- Significant personality disorder. 
 Assuming a response rate of 80%, we expect to have 50 HCP in each hospital, who will be 
divided into 50 for each arm. 
Randomization/ Allocation Concealment 
Using central randomization. 
Sequence Generation 
Computerized random number generator 
Blinding 
Triple blinded conduction of the study 
The participants, those administering the interventions, and those assessing the outcomes were 
blinded to group assignment. 
Statistical analysis: 
Statistical analyses were performed using 'IBM SPSS Statistics for Windows, version 21’, the 
level of statistical significance was set at 0.05 (two-tailed).  
For describing the sample characteristics, Categorical data were demonstrated as number and 
percent. Numerical data, including the results of the 3 scales, were presented as minimum, 
maximum and average.  
Scores were tested for normality using skewness and kurtosis coefficients (less than one were 
considered normal), besides box plots and normal Q-Q plot.  
Effect of the intervention and factors associated with the magnitude of change in the three 
studied scales were tested using General linear models (repeated measures ANOVA). 

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Further investigation was done to present the percent of improvement in each scale. Change of 
the scores were computed as post-pre scores, improvement was considered if WHO-5 and 
resilience change was >zero and if change in anxiety scores was <zero. 
Logistic regression was used to test for potential factors associated with improvement of each 
scale. 
Secondary Bivariate analyses were done using correlation coefficient, independent samples t-test 
and Mann Whitney u test, one-way ANOVA (for relations with numerical variables) and chi 
square test (for testing association between categorical variables). 
Alzahrani, A. M., Hakami, A., AlHadi, A., Batais, M. A., Alrasheed, A. A., & Almigbal, T. H. 
(2020). The interplay between mindfulness, depression, stress and academic performance 
in medical students: A Saudi perspective. Plos one, 15(4), e0231088 . 
Barnes, S. M., & Lynn, S. J. (2010). Mindfulness skills and depressive symptoms: A longitudinal 
study. Imagination, Cognition and Personality, 30(1), 77-91 . 
Belen, H. (2020). Fear of COVID-19 and Mental Health: The Role of Mindfulness in During 
Time of Crisis . 
Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., . . . Velting, D. 
(2004). Mindfulness: A proposed operational definition. Clinical psychology: Science 
and practice, 11(3), 230-241 . 
Brooks, S. K., Chalder, T., & Gerada ,C. (2011). Doctors vulnerable to psychological distress 
and addictions: treatment from the Practitioner Health Programme. Journal of Mental 
Health, 20(2), 157-164 . 
Carmody, J., & Baer, R. A. (2008). Relationships between mindfulness practice and levels of 
mindfulness, medical and psychological symptoms and well-being in a mindfulness-
based stress reduction program. Journal of behavioral medicine, 31(1), 23-33 . 
Dane, E., & Brummel, B. J. (2014). Examining workplace mindfulness and its relations to job 
performance and turnover intention. Human relations, 67(1), 105-128 . 
Epstein, R. M. (1999). Mindful practice. Jama, 282(9), 833-839 . 
European Centre for Disease Prevention and Control. (2020). 2020, from 
https://www.ecdc.europa.eu/en/covid-19-pandemic 
Holmes, E. A., O'Connor, R. C., Perry, V. H., Tracey, I., Wessely, S., Arseneault, L., . . . Everall, 
I. (2020). Multidisciplinary research priorities for the COVID-19 pandemic: a call for 
action for mental health science. The Lancet Psychiatry . 
Kabat-Zinn ,J. (1990). Using the wisdom of your body and mind to face stress, pain, and illness. 
New York, NY: Bantam Doubleday Dell . 
Khoury, B., Lecomte, T., Fortin, G., Masse, M., Therien, P., Bouchard, V., . . . Hofmann, S. G. 
(2013). Mindfulness-based therapy :a comprehensive meta-analysis. Clinical psychology 
review, 33(6), 763-771 . 

10 
 
Sunday, December 6, 2020 
Kiyoshi-Teo, H., Krein, S. L., & Saint, S. (2013). Applying mindful evidence-based practice at 
the bedside using catheter-associated urinary tract infection as a model. Infection Control 
& Hospital Epidemiology, 34(10), 1099-1101 . 
 
Kluge, H. (2020). WHO Regional Director for Europe—Statement to the Press: Physical and 
Mental Health Key to Resilience during COVID-19 Pandemic. WHO: Copenhagen, 
Denmark . 
La Torre, G., Raffone, A., Peruzzo, M., Calabrese, L., Cocchiara, R. A., D’Egidio, V., . . . 
Mannocci, A. (2020). Yoga and Mindfulness as a Tool for Influencing Affectivity, 
Anxiety, Mental Health, and Stress among Healthcare Workers: Results of a Single-Arm 
Clinical Trial. Journal of Clinical Medicine, 9(4), 1037 . 
Lai, J., Ma, S., Wang, Y., Cai, Z., Hu, J., Wei, N., . . . Li, R. (2020). Factors associated with 
mental health outcomes among health care workers exposed to coronavirus disease 2019. 
JAMA network open, 3(3), e203976-e203 679
 .
 
Leroy, H., Anseel, F., Dimitrova, N. G., & Sels, L. (2013). Mindfulness, authentic functioning, 
and work engagement: A growth modeling approach. Journal of Vocational Behavior, 
82(3), 238-247 . 
Lu, W., Wang, H., Lin, Y., & Li, L. (2020). Psychological status of medical workforce during 
the COVID-19 pandemic: A cross-sectional study. Psychiatry research, 112936 . 
Organization, W. H. (2020). Mental health and psychosocial considerations during the COVID-
19 outbreak, 18 March 2020: World Health Organization. 
Segal, Z. V., Teasdale, J. D., Williams, J. M., & Gemar, M. C. (2002). The mindfulness‐based 
cognitive therapy adherence scale: Inter‐rater reliability, adherence to protocol and 
treatment distinctiveness. Clinical Psychology & Psychotherapy, 9
(
2
 ,)
131
-
131
 .
 
Singh, R., Singh, B., Mahato, S., & Hambour, V. K. (2020). Social support, emotion regulation 
and mindfulness: A linkage towards social anxiety among adolescents attending 
secondary schools in Birgunj, Nepal. Plos one, 15(4), e0230991 . 
Sutcliffe, K. M., Vogus, T. J., & Dane, E. (2016). Mindfulness in organizations: A cross-level 
review. Annual Review of Organizational Psychology and Organizational Behavior, 3, 
55-81 . 
Svendsen, J. L., Kvernenes, K. V., Wiker, A. S., & Dundas, I. (2017). Mechanisms of 
mindfulness: Rumination and self-compassion. Nordic Psychology, 69(2), 71-82 . 
Tan, B. Y., Chew, N. W., Lee, G. K., Jing, M., Goh, Y., Yeo, L. L., . . . Khan, F. A. (2020). 
Psychological impact of the COVID-19 pandemic on health care workers in Singapore. 
Annals of internal medicine . 
Vaughn, V. M., & Flanders, S. A. (2016). Annals for Hospitalists Inpatient Notes-Mindfulness 
and Antibiotic Appropriateness—How Point-of-Care Stewardship Begins With 
Hospitalists. Annals of internal medicine, 165
(
11
 ,)
HO2-HO3 . 
Vogus, T. J., Cooil, B., Sitterding, M., & Everett, L. Q. (2014). Safety organizing, emotional 
exhaustion, and turnover in hospital nursing units. Medical care, 870-876 . 
Zemestani, M., & Nikoo, Z. F. (2019). Effectiveness of mindfulness-based cognitive therapy for 
comorbid depression and anxiety in pregnancy: a randomized controlled trial. Archives of 
Women's Mental Health, 1-8 . 
Zhang, W.-r., Wang, K., Yin, L., Zhao, W.-f., Xue, Q., Peng, M., . . . Du, J.-l. (2020). Mental 
health and psychosocial problems of medical health workers during the COVID-19 
epidemic in China. Psychotherapy and psychosomatics, 89(4), 242-250 .  

11 
 
Sunday, December 6, 2020 
Gilmartin, H., Goyal, A., Hamati, M. C., Mann, J., Saint, S., & Chopra, V. (2017). Brief 
mindfulness practices for healthcare providers–a systematic literature review. The 
American journal of medicine, 130(10), 1219-e1. 
Howarth, A., Perkins-Porras, L., Smith, J. G., Subramaniam, J., Copland, C., Hurley, M., ... & 
Ussher, M. (2016). Pilot study evaluating a brief mindfulness intervention for those with 
chronic pain: study protocol for a randomized controlled trial. Trials, 17(1), 273. 
Howarth, A., Smith, J. G., Perkins-Porras, L., & Ussher, M. (2019). Effects of brief mindfulness-
based interventions on health-related outcomes: A systematic review. Mindfulness, 1-12.