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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720404
• Other study ID #: MFN-COVID-19 2020-22
• Status: Completed
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: June 9, 2022

Study information

• Verified date: July 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 9, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Health Personnel
• Mindfulness
• Psychopathology
• Randomized Controlled Trial

Intervention

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:
• 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.
• 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.).

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At baseline, 2 weeks, 1, 4 and 7 months
Other	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.	At baseline, 2 weeks, 1, 4 and 7 months
Other	Repetitive negative thinking	Measured by the 15-item Perseverative Thinking Questionnaire (PTQ)PTQ consists of 15-items and assess repetitive negative thinking.	At baseline, 2 weeks, 1, 4 and 7 months
Other	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.	At baseline, 2 weeks, 1, 4 and 7 months
Other	Covid-related aspects	A variety of facets related to COVID-19 (work, society and person-related) will be elucidated by a 21-item questionnaire.	At baseline, 1, 4 and 7 months
Primary	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.	Change between baseline and 7 months
Secondary	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.	At 7-months follow-up
Secondary	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.	At baseline, 1, 4 and 7 months
Secondary	Severity of insomnia	Measured by the Insomnia Severity Index (ISI), a 7-item self-reported screening measure for insomnia.	At baseline, 1, 4 and 7 months
Secondary	Alcohol use	Measured by the Alcohol Use Disorders Identification Test (AUDIT-C) consisting of 10 items being a screening method for unhealthy alcohol use.	At baseline, 1, 4 and 7 months
Secondary	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.	At baseline, 1, 4 and 7 months
Secondary	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.	At baseline, 1, 4 and 7 months
Secondary	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).	At baseline, 1, 4 and 7 months
Secondary	Costs	This will be investigated by using the Treatment Inventory Costs associated with Psychiatric Illness (TiC-P) as a measure of healthcare utilization.	At 7 months follow-up