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Resilience Intervention for Health Professionals COVID-19

Primary Purpose

Mental Health Wellness 1

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mindfulness-based Intervention
Sponsored by
Universidad de Monterrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Wellness 1 focused on measuring mindfulness, resilience, COVID-19, nurses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Signed informed consent

Exclusion Criteria:

  • Lack of signature in the informed consent

Sites / Locations

  • TecSalud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling. This was administered via a webpage designed for this intervention.

Outcomes

Primary Outcome Measures

Change from Baseline to 6 months follow-up of Subjective Well-being
Subjective Well-Being will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Change from Baseline to 6 months follow-up of Negative Emotions
Negative Emotions will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Change from Baseline to 6 months follow-up of Perception of Health
Perception of Health will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Change from Baseline to 6 months follow-up of Stress
Stress will be measured using the perceived stress scale.
Change from Baseline to 6 months follow-up of Resilience
Resilience will be measured using the brief resilience scale
Change from Baseline to 6 months follow-up of mindfulness
Resilience will be measured using the mindfulness-awareness attention scale
Change from Baseline to 6 months follow-up of burnout
Burnout will be measured using the Burnout Clinical Subtypes Questionnaire

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
August 23, 2022
Sponsor
Universidad de Monterrey
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1. Study Identification

Unique Protocol Identification Number
NCT05515172
Brief Title
Resilience Intervention for Health Professionals COVID-19
Official Title
Resilience Intervention in Times of Crisis for Health Professionals During the COVID-19 Contingency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Monterrey

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1
Keywords
mindfulness, resilience, COVID-19, nurses

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling. This was administered via a webpage designed for this intervention.
Intervention Type
Other
Intervention Name(s)
Mindfulness-based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline to 6 months follow-up of Subjective Well-being
Description
Subjective Well-Being will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Time Frame
At baseline, and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of Negative Emotions
Description
Negative Emotions will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Time Frame
At baseline, and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of Perception of Health
Description
Perception of Health will be measured using the PERMA Profiler which evaluates positive emotions, engagement, relationships, meaning, accomplishments, perception of health, and negative emotions.
Time Frame
At baseline, and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of Stress
Description
Stress will be measured using the perceived stress scale.
Time Frame
At baseline and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of Resilience
Description
Resilience will be measured using the brief resilience scale
Time Frame
At baseline and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of mindfulness
Description
Resilience will be measured using the mindfulness-awareness attention scale
Time Frame
At baseline and 6 months follow-up
Title
Change from Baseline to 6 months follow-up of burnout
Description
Burnout will be measured using the Burnout Clinical Subtypes Questionnaire
Time Frame
At baseline and 6 months follow-up

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Signed informed consent Exclusion Criteria: Lack of signature in the informed consent
Facility Information:
Facility Name
TecSalud
City
San Pedro Garza Garcia
State/Province
Nuevo Leon
ZIP/Postal Code
66278
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Resilience Intervention for Health Professionals COVID-19

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