- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05515172
Resilience Intervention for Health Professionals COVID-19
August 23, 2022 updated by: Universidad de Monterrey
Resilience Intervention in Times of Crisis for Health Professionals During the COVID-19 Contingency
In the fight against the coronavirus (COVID-19) pandemic, health personnel, especially nursing staff, have been facing enormous pressure, including a high risk of infection and inadequate protection against contamination, overwork, frustration, discrimination, isolation, lack of contact with their families and exhaustion.
Therefore, the World Health Organization (WHO) has requested particular interventions to promote emotional well-being in health workers exposed to COVID-19, which must be implemented immediately, especially those aimed at women and nursing staff. .
Psychological support services, including counseling or intervention via phone, internet, and apps, have been widely deployed by local and national mental health institutions in response to the COVID-19 outbreak.
Complementing these efforts, the present study seeks, through mind-body medicine strategies, to promote resilience among nurses exposed to COVID-19 in critical phases.
A multidisciplinary team of expert volunteers designed the intervention in different mind-body medicine techniques (for example, medicine, psychology, thanatology, meditation, health, and wellness coaches, certified Qi Gong, and yoga instructors) and is made up of 3 components main: "micropractices," cohesion and support groups, which will be implemented for 12 weeks in health personnel.
This intervention responds to the international call to promote health personnel's physical and emotional health during the COVID-19 pandemic, offering an opportunity to accompany them during this time and mitigate the effects on health in the short and long term.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
371
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nuevo Leon
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San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
- TecSalud
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent
Exclusion Criteria:
- Lack of signature in the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling.
This was administered via a webpage designed for this intervention.
|
The intervention was designed by a volunteer multidisciplinary team expert in different mind-body medicine techniques (for example, medicine, psychology, thanatology, meditation, health, and wellness coaches, certified Qi Gong, and yoga instructors) and is made up of 3 components main: "micropractices," cohesion and support groups, which will be implemented for a period of 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to 6 months follow-up of Subjective Well-being
Time Frame: At baseline, and 6 months follow-up
|
Subjective Well-Being will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
|
At baseline, and 6 months follow-up
|
Change from Baseline to 6 months follow-up of Negative Emotions
Time Frame: At baseline, and 6 months follow-up
|
Negative Emotions will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
|
At baseline, and 6 months follow-up
|
Change from Baseline to 6 months follow-up of Perception of Health
Time Frame: At baseline, and 6 months follow-up
|
Perception of Health will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
|
At baseline, and 6 months follow-up
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Change from Baseline to 6 months follow-up of Stress
Time Frame: At baseline and 6 months follow-up
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Stress will be measured using the perceived stress scale.
|
At baseline and 6 months follow-up
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Change from Baseline to 6 months follow-up of Resilience
Time Frame: At baseline and 6 months follow-up
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Resilience will be measured using the brief resilience scale
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At baseline and 6 months follow-up
|
Change from Baseline to 6 months follow-up of mindfulness
Time Frame: At baseline and 6 months follow-up
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Resilience will be measured using the mindfulness-awareness attention scale
|
At baseline and 6 months follow-up
|
Change from Baseline to 6 months follow-up of burnout
Time Frame: At baseline and 6 months follow-up
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Burnout will be measured using the Burnout Clinical Subtypes Questionnaire
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At baseline and 6 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
May 30, 2020
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
August 23, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
August 25, 2022
Last Update Submitted That Met QC Criteria
August 23, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20191210-CEI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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