Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT04555005

Collaborator

Hospital Universitario La Paz (Other)

1,000

Enrollment

Location

Arm

1.5

Actual Duration (Months)

647.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness COVID-19 Healthcare Worker	Other: Mindfulness based intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Implementation of a Mindfulness-based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain

Actual Study Start Date :

Mar 10, 2020

Actual Primary Completion Date :

Apr 26, 2020

Actual Study Completion Date :

Apr 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Mindfulness based intervention Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak	Other: Mindfulness based intervention Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak

Arm

Intervention/Treatment

Other: Mindfulness based intervention

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

Other: Mindfulness based intervention

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

Outcome Measures

Primary Outcome Measures

Perceived helpfulness to reduce current stress [through study completion, up to three days]
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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Extreme adverse events

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	La Paz University Hospital	Madrid		Spain	28046

Sponsors and Collaborators

Instituto de Investigación Hospital Universitario La Paz
Hospital Universitario La Paz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Investigación Hospital Universitario La Paz

ClinicalTrials.gov Identifier:

NCT04555005

Other Study ID Numbers:

Mind-COVID-19

First Posted:

Sep 18, 2020

Last Update Posted:

Sep 18, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 18, 2020