Clinical trial NCT04720404: Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)
Official title: Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Randomized Controlled Trial
Psychopathology
Health Personnel
Keywords: COVID-19
Mindfulness-Based Stress Reduction
Healthcare workers
Positive Mental Health
Working mechanisms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial of interactive MBSR program added to support as usual (MBSR + SAU) versus support as usual with daily self-help mindfulness exercises via a YouTube-channel (SAU + DMYT)
Primary purpose: PREVENTION

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.).

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

Primary outcomes:
measure: Somatoform symptoms, Anxiety, Depression
timeFrame: Change between baseline and 7 months
Secondary outcomes:
measure: Occurence of psychopathology
timeFrame: At 7-months follow-up
measure: Post-traumatic stress symptoms
timeFrame: At baseline, 1, 4 and 7 months
measure: Severity of insomnia
timeFrame: At baseline, 1, 4 and 7 months
measure: Alcohol use
timeFrame: At baseline, 1, 4 and 7 months
measure: Posttraumatic growth
timeFrame: At baseline, 1, 4 and 7 months
measure: Positive mental health
timeFrame: At baseline, 1, 4 and 7 months
measure: Health-related quality of life
timeFrame: At baseline, 1, 4 and 7 months
measure: Costs
timeFrame: At 7 months follow-up
Other outcomes:
measure: Mindfulness skills
timeFrame: At baseline, 2 weeks, 1, 4 and 7 months
measure: Self-compassion
timeFrame: At baseline, 2 weeks, 1, 4 and 7 months
measure: Repetitive negative thinking
timeFrame: At baseline, 2 weeks, 1, 4 and 7 months
measure: Mindfulness practice
timeFrame: At baseline, 2 weeks, 1, 4 and 7 months
measure: Covid-related aspects
timeFrame: At baseline, 1, 4 and 7 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: Radboud University Medical Center
name: Anne Speckens, Prof.
role: PRINCIPAL_INVESTIGATOR
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