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

NCT04720404 | Completed DMC

• 1 other identifier: MFN-COVID-19 2020-22
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Randomized Controlled Trial; Psychopathology; Health Personnel

Keywords

COVID-19; Mindfulness-Based Stress Reduction; Healthcare workers; Positive Mental Health; Working mechanisms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Occurence of psychopathology

  At 7-months follow-up

• Post-traumatic stress symptoms

  At baseline, 1, 4 and 7 months

• Severity of insomnia

  At baseline, 1, 4 and 7 months

• Alcohol use

  At baseline, 1, 4 and 7 months

• Posttraumatic growth

  At baseline, 1, 4 and 7 months

Other Outcomes (5)

• Mindfulness skills

  At baseline, 2 weeks, 1, 4 and 7 months

• Self-compassion

  At baseline, 2 weeks, 1, 4 and 7 months

• Repetitive negative thinking

  At baseline, 2 weeks, 1, 4 and 7 months

Study Arms (2)

Mindfulness Based Stress Reduction program

EXPERIMENTAL

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

Daily self-help mindfulness exercises via YouTube-channel

ACTIVE COMPARATOR

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

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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

Mindfulness Based Stress Reduction program

Self-help mindfulness/compassion exercises OTHER

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.

Daily self-help mindfulness exercises via YouTube-channel

Support as usual OTHER

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.).

Daily self-help mindfulness exercises via YouTube-channel; Mindfulness Based Stress Reduction program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Impossibility to obtain a valid informed consent
• Insufficient comprehension of the Dutch language
• Inability to access the interactive videoconferencing

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (21)

• Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.

  PMID: 21586480 BACKGROUND

• Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, Danhauer SC. A short form of the Posttraumatic Growth Inventory. Anxiety Stress Coping. 2010;23(2):127-37. doi: 10.1080/10615800903094273.

  PMID: 19582640 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7.

  PMID: 20633738 BACKGROUND

• Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.

  PMID: 20973032 BACKGROUND

• Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

  PMID: 18388841 BACKGROUND

• Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

  PMID: 21584907 BACKGROUND

• Schippers GM, Broekman TG, Buchholz A, Koeter MW, van den Brink W. Measurements in the Addictions for Triage and Evaluation (MATE): an instrument based on the World Health Organization family of international classifications. Addiction. 2010 May;105(5):862-71. doi: 10.1111/j.1360-0443.2009.02889.x. Epub 2010 Mar 10.

  PMID: 20331557 BACKGROUND

• Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.

  BACKGROUND

• Ehring T, Zetsche U, Weidacker K, Wahl K, Schonfeld S, Ehlers A. The Perseverative Thinking Questionnaire (PTQ): validation of a content-independent measure of repetitive negative thinking. J Behav Ther Exp Psychiatry. 2011 Jun;42(2):225-32. doi: 10.1016/j.jbtep.2010.12.003. Epub 2010 Dec 21.

  PMID: 21315886 BACKGROUND

• Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

  PMID: 32202646 BACKGROUND

• Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.

  PMID: 29126747 BACKGROUND

• Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.

  PMID: 25818837 BACKGROUND

• Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384.

  PMID: 19773563 BACKGROUND

• Shapiro SL, Schwartz GE, Bonner G. Effects of mindfulness-based stress reduction on medical and premedical students. J Behav Med. 1998 Dec;21(6):581-99. doi: 10.1023/a:1018700829825.

  PMID: 9891256 BACKGROUND

• Verweij H, van Ravesteijn H, van Hooff MLM, Lagro-Janssen ALM, Speckens AEM. Mindfulness-Based Stress Reduction for Residents: A Randomized Controlled Trial. J Gen Intern Med. 2018 Apr;33(4):429-436. doi: 10.1007/s11606-017-4249-x. Epub 2017 Dec 18.

  PMID: 29256091 BACKGROUND

• Kabat-Zinn J, Full Catastrophe Living (Revised Edition): Using the wisdom of your body and mind to face stress, pain, and illness. 2013. Random House Publishing Group.

  BACKGROUND

• Arts-de Jong M, Geurts DEM, Spinhoven P, Ruhe HG, Speckens AEM. Mindfulness-Based Interventions for Mental Health Outcomes in Frontline Healthcare Workers During the COVID-19 Pandemic: A Randomized Controlled Trial. J Gen Intern Med. 2025 Nov;40(15):3705-3714. doi: 10.1007/s11606-025-09529-z. Epub 2025 May 19.

  PMID: 40388083 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Mindfulness-Based Stress Reduction; Palliative Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anne Speckens, Prof.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes on psychiatric interview will be assessed by independent research assistants blind to condition. Participants will be instructed to avoid unblinding as much as possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anne Speckens

Model Details: 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)

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 22, 2021
• Study Start: June 23, 2020
• Primary Completion: June 2, 2022
• Study Completion: June 9, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: We expect the final report of the primary endpoint of the study in May 2022, and we will have an embargo period of 6 months after publication.
• Access Criteria: We will use restricted access, such that interested researchers are welcome to contact us with requests for data. The project team will review the quality of the request and grant permission if the request is in accordance with the terms of use drafted by the Radboudumc.

Locations

NL (1)