NCT04555005

Brief Summary

The COVID-19 outbreak is having an impact on the well-being of healthcare workers. Previous reports on pandemics show that such an impact may last beyond the time of the outbreak. Mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. This single-arm trial explores the acceptability, safety and usefulness of an on-site, brief Mindfulness-based intervention to reduce stress for front line health workers during a crisis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

June 11, 2020

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived helpfulness to reduce current stress

    The outcome was measured by a 10-point visual analogue scale developed for this study, where 0 was "it did not help me at all" and 10 was "it helped me a lot".

    through study completion, up to three days

Study Arms (1)

Mindfulness based intervention

OTHER

Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak

Other: Mindfulness based intervention

Interventions

Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak

Mindfulness based intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All frontline healthcare workers present in the ward at the time of intervention

You may not qualify if:

  • Extreme adverse events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

  • Rodriguez-Vega B, Palao A, Munoz-Sanjose A, Torrijos M, Aguirre P, Fernandez A, Amador B, Rocamora C, Blanco L, Marti-Esquitino J, Ortiz-Villalobos A, Alonso-Sanudo M, Cebolla S, Curto J, Villanueva R, de-la-Iglesia MJ, Carracedo D, Casado C, Vidal E, Trigo D, Iglesias N, Cabanas D, Mellado L, Garcia D, Fernandez-Encinas C, Navarro R, Mediavilla R, Vidal-Villegas MP, Bravo-Ortiz MF, Bayon C. Implementation of a Mindfulness-Based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain. Front Psychiatry. 2020 Oct 30;11:562578. doi: 10.3389/fpsyt.2020.562578. eCollection 2020.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

September 18, 2020

Study Start

March 10, 2020

Primary Completion

April 26, 2020

Study Completion

April 26, 2020

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations