Official Title
Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)
Brief Summary

The current study will be a randomized controlled trial (RCT) investigating an adapted online Mindfulness-Based Stress Reduction (MBSR) program versus daily online self-help mindfulness exercises, in preventing incident/prevalent psychopathology in healthcare workers allocated to work with COVID-19 patients. Outcome measures include depression, anxiety, somatoform symptoms, post-traumatic stress, insomnia, substance abuse, post-traumatic growth and positive mental health. The study also aims to explore possible working mechanisms such as perseverative thinking, mindfulness skills and self-compassion. The study will have a follow-up duration of 7 months from baseline.

Detailed Description

Introduction With the rapid developments to anticipate and manage the ongoing COVID-19
pandemic, healthcare personnel is quickly reallocated to COVID-19 units. These people will
experience substantial amounts of stress which has been shown to result in the development or
increase of stress related disorders like psychological distress and psychopathology in
50-70%. Adaptive reconsolidation of stressful events is required for resilience against
prolonged stress and prevent development and/or recurrence of psychopathology.

Mindfulness-based interventions (MBIs) are potent interventions with profitable results in
many people with and without stress-related disorders. These interventions invite people to
allow bodily sensations, thoughts and feelings in reaction to and in the aftermath of
stressors and pay attention to them in a particular way: on purpose, in the present moment,
and without judgment. The effectiveness of these interventions on stress reduction is now
founded on a strong meta-analytical evidence base in symptom and stress-reduction in diverse
clinical and non-clinical populations.

Mindfulness-based Stress Reduction (MBSR) is a specific stress-focused MBI. In healthcare
professionals, MBSR training increased well-being, mindfulness skills, empathy and emotional
stability and decreased burnout, anxiety, and depression. A randomized clinical trial showed
that specifically residents with high baseline levels of emotional exhaustion benefitted from
MBSR. Moreover, MBSR can be delivered effectively via interactive video-conferencing, which
makes it suited to quickly support relatively large groups of healthcare workers.

Taken together that MBSR has beneficial effects in healthcare workers and is aimed at dealing
with stress, this makes it a potentially useful intervention to prevent psychopathological
sequela of the high-stress situations for healthcare workers inherent to the current COVID-19
outbreak. However, the effectiveness of an additional MBSR intervention in a severe crisis
situation like the COVID-19 outbreak needs to be empirically investigated in a prospective
study, before large scale implementation is advocated.

Aims The aim of the study is to investigate the effectiveness of an adapted online MBSR added
to Support As Usual (SAU) versus daily self-help mindfulness exercises via a YouTube-channel
(DMYT) + SAU on the incidence and prevalence of psychological distress and psychopathology
(anxiety, depression, somatoform symptoms). In addition, we aim to decrease post-traumatic
stress symptoms, insomnia, substance abuse and health-related costs more in the MBSR + SAU
group. We also aim to improve the post-traumatic growth, positive mental health and
health-related quality of life. Furthermore, we will investigate whether improving
mindfulness skills and self-compassion and decreasing repetitive negative thinking may help
reduce psychological distress (working mechanism).

Method A two-armed randomized, controlled superiority trial comparing an adapted MBSR + SAU
versus DMYT + SAU for reducing psychological distress and psychopathology in healthcare
workers working with COVID-19 patients. Assessments will be conducted at baseline, post
intervention (1 month) and follow-up at 4 and 7 months.

The intervention is an interactive adapted online MBSR program. The training consists of
eight 1.5 hour group sessions twice per week during 4 weeks and daily home practice
assignments guided by audio files. The sessions will be held via interactive video-streaming.
MBSR courses will be taught by qualified mindfulness teachers. Participants in the control
condition will have the possibility to use a self-help daily mindfulness exercise of 30
minutes on a YouTube channel (DMYT) for 4 weeks. Both will be offered on top of the other
interventions (SAU) already available in the hospital or organization (e.g. buddy-, team- and
peer support system, shopping/dinner service, etc.).

Completed
Mindfulness
Randomized Controlled Trial
Psychopathology
Health Personnel

Behavioral: Mindfulness-Based Stress Reduction

Participants in the intervention group will follow a 4-week adapted MBSR training. The training consists of biweekly sessions of 1,5 hours. The training is structured based on the Mindfulness-Based Stress Reduction training as originally designed by John Kabat Zinn. The program includes both formal and informal meditation exercises.
Other Name: Array

Other: Self-help mindfulness/compassion exercises

Participants in the self-help group will receive a 4-week program with daily suggestions for mindfulness/compassion exercises of 30 minutes on a YouTube-channel. Participants can schedule the exercises themselves.

Other: Support as usual

Support as usual (SAU) consists of facilities or interventions already available healthcare organisations provided to their healthcare workers (e.g. buddy-, team- and peer support system, shopping/dinner service etc.).

Eligibility Criteria

Inclusion Criteria:

- Healthcare workers who are either currently or in past have been working directly with
COVID-19 patients, e.g. on COVID-19 ward/intensive care unit.

Exclusion Criteria:

- Impossibility to obtain a valid informed consent

- Insufficient comprehension of the Dutch language

- Inability to access the interactive videoconferencing

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Netherlands
Locations

Radboud university medical center
Nijmegen, Netherlands

Anne Speckens, Prof., Principal Investigator
Radboud University Medical Center

Radboud University Medical Center
NCT Number
Keywords
Covid-19
Mindfulness-Based Stress Reduction
Healthcare Workers
Positive Mental Health
Working mechanisms
MeSH Terms
COVID-19