Back to resultsMindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
Primary Purpose
Mindfulness, COVID-19, Healthcare Worker
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness based intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Mindfulness
Eligibility Criteria
Inclusion Criteria:
- All frontline healthcare workers present in the ward at the time of intervention
Exclusion Criteria:
- Extreme adverse events
Sites / Locations
- La Paz University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mindfulness based intervention
Arm Description
Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT04555005
First Posted
June 11, 2020
Last Updated
September 17, 2020
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT04555005
Brief Title
Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
April 26, 2020 (Actual)
Study Completion Date
April 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, COVID-19, Healthcare Worker
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based intervention
Arm Type
Other
Arm Description
Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak
Intervention Type
Other
Intervention Name(s)
Mindfulness based intervention
Intervention Description
Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak
Primary Outcome Measure Information:
Title
Perceived helpfulness to reduce current stress
Description
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".
Time Frame
through study completion, up to three days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All frontline healthcare workers present in the ward at the time of intervention
Exclusion Criteria:
Extreme adverse events
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33329103
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
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