An interventional study of Mindfulness-Based Stress Reduction and Self-help mindfulness/compassion exercises in Mindfulness, Randomized Controlled Trial and Psychopathology, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention
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.
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.).
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 201 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Healthcare workers in the MBSR arm will be invited to participate in an adapted online MBSR program added to support as usual
Behavioral: Mindfulness-Based Stress Reduction · Other: Support as usual
Healthcare workers in the self-help arm will be invited to follow a self-help program with mindfulness/compassion exercises of 30 minutes per day via YouTube channel
Other: Self-help mindfulness/compassion exercises · Other: Support as usual
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.
Also known as: MBSR, Mindfulness-based Intervention
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.
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.).
Somatoform symptoms, Anxiety, Depression
Measured by the Patient Health Questionnaire - Somatoform symptoms, Anxiety, Depression (PHQ-SADS). The PHQ-SADS is a 31-item self-reported measure combining 3 questionnaires, the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7) and the 15-item Patient Health Questionnaire (PHQ-15). The PHQ-9 is designed to measure depression in general medical and mental health settings. The GAD-7 measures severity of anxiety. The PHQ-15 is used to screen for somatization and monitoring somatic symptoms severity.
Time frame: Change between baseline and 7 months
Occurence of psychopathology
This will be assessed by a Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-V). This diagnostic instrument assess occurence of depression, anxiety disorder, PTSS, substance abuse and somatoform disorder.
Time frame: At 7-months follow-up
Post-traumatic stress symptoms
Measured by the PTSS Checklist for the DSM-5 (PCL-5). This is a 20-item self-report measure to assess the 20 DSM-5 symptoms of post-traumatic stress disorder.
Time frame: At baseline, 1, 4 and 7 months
Severity of insomnia
Measured by the Insomnia Severity Index (ISI), a 7-item self-reported screening measure for insomnia.
Time frame: At baseline, 1, 4 and 7 months
Alcohol use
Measured by the Alcohol Use Disorders Identification Test (AUDIT-C) consisting of 10 items being a screening method for unhealthy alcohol use.
Time frame: At baseline, 1, 4 and 7 months
Posttraumatic growth
Measured by the Posttraumatic Growth Inventory-Short Form (PTGI-SF). The PTGI-SF is a 10-item questionnaire and measures the general tendency to experience difficult events in such a way that benefits are perceived.
Time frame: At baseline, 1, 4 and 7 months
Positive mental health
Measured by the Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a questionnaire consisting of 14 items measuring emotional, social and psychological well-being.
Time frame: At baseline, 1, 4 and 7 months
Health-related quality of life
Measured by the EuroQol-5D-5L. The EQ-5D-5L consist of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems).
Time frame: At baseline, 1, 4 and 7 months
Costs
This will be investigated by using the Treatment Inventory Costs associated with Psychiatric Illness (TiC-P) as a measure of healthcare utilization.
Time frame: At 7 months follow-up
Mindfulness skills
Measured by the 24-item Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) divided into the subscales observing, describing, acting with awareness, non-judging and non-reactivity.
Time frame: At baseline, 2 weeks, 1, 4 and 7 months
Self-compassion
Measured by the 12-item Dutch Self-Compassion Scale - Short Form (SCS-SF) consisting of six components, including self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.
Time frame: At baseline, 2 weeks, 1, 4 and 7 months
Repetitive negative thinking
Measured by the 15-item Perseverative Thinking Questionnaire (PTQ)PTQ consists of 15-items and assess repetitive negative thinking.
Time frame: At baseline, 2 weeks, 1, 4 and 7 months
Mindfulness practice
This questionnaire lists the intensity and form of formal and informal mindfulness exercises the participant conducted in the past 2 months at baseline, or in-between the questionnaires for the other follow-up measures. In addition, this list makes an inventory of whether participants have followed another intervention in addition to the mindfulness intervention offered in this study.
Time frame: At baseline, 2 weeks, 1, 4 and 7 months
Covid-related aspects
A variety of facets related to COVID-19 (work, society and person-related) will be elucidated by a 21-item questionnaire.
Time frame: At baseline, 1, 4 and 7 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The authors intend to make the data available to other researchers after completion of the study and will comply with open access procedures, including open access publishing as much as possible.
Supporting information: Study protocol, Sap, Analytic code
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Radboud University Medical Center