Mental Health Wellness 1NCT05515172
Resilience Intervention for Health Professionals COVID-19
A study testing Mindfulness-based Intervention in people with Mental Health Wellness 1, run by Universidad de Monterrey at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Mindfulness-based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
Who cannot join
- Lack of signature in the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Mindfulness-based Intervention
- Keywords
- mindfulness, resilience, COVID-19, nurses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling. This was administered via a webpage designed for this intervention. Receives: Other: Mindfulness-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, and 6 months follow-up
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.
Measured: At baseline, and 6 months follow-up
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.
Measured: At baseline, and 6 months follow-up
Change from Baseline to 6 months follow-up of Stress
Stress will be measured using the perceived stress scale.
Measured: At baseline and 6 months follow-up
Change from Baseline to 6 months follow-up of Resilience
Resilience will be measured using the brief resilience scale
Measured: At baseline and 6 months follow-up
Change from Baseline to 6 months follow-up of mindfulness
Resilience will be measured using the mindfulness-awareness attention scale
Measured: At baseline and 6 months follow-up
Change from Baseline to 6 months follow-up of burnout
Burnout will be measured using the Burnout Clinical Subtypes Questionnaire
Measured: At baseline and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Apr 2020
- Primary completion30 May 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515172
- Sponsor's protocol ID
- 20191210-CEI
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cepeda-Lopez AC, Solis Dominguez L, Villarreal Zambrano S, Garza-Rodriguez IY, Del Valle AC, Quiroga-Garza A. A comparative study of well-being, resilience, mindfulness, negative emotions, stress, and burnout among nurses after an online mind-body based intervention during the first COVID-19 pandemic crisis. Front Psychol. 2023 Mar 13;14:848637. doi: 10.3389/fpsyg.2023.848637. eCollection 2023.
PubMed 36993886
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Intervention in Times of Crisis for Health Professionals During the COVID-19 Contingency
- ClinicalTrials.gov ID
- NCT05515172
- Acronym / sponsor ID
- 20191210-CEI
- Conditions
- Mental Health Wellness 1
- Keywords
- mindfulness, resilience, COVID-19, nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Universidad de MonterreyUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mindfulness-based InterventionMindfulness-based intervention is composed of micropractices, cohesion groups, affirmations, and journaling. This was administered via a webpage designed for this intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (1 listed)
- Lack of signature in the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based InterventionThe 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. | Other | Intervention group |
Primary outcome
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.
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.
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.
Change from Baseline to 6 months follow-up of Stress
Time frame: At baseline and 6 months follow-up
Stress will be measured using the perceived stress scale.
Change from Baseline to 6 months follow-up of Resilience
Time frame: At baseline and 6 months follow-up
Resilience will be measured using the brief resilience scale
Change from Baseline to 6 months follow-up of mindfulness
Time frame: At baseline and 6 months follow-up
Resilience will be measured using the mindfulness-awareness attention scale
Change from Baseline to 6 months follow-up of burnout
Time frame: At baseline and 6 months follow-up
Burnout will be measured using the Burnout Clinical Subtypes Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 36993886Cepeda-Lopez AC, Solis Dominguez L, Villarreal Zambrano S, Garza-Rodriguez IY, Del Valle AC, Quiroga-Garza A. A comparative study of well-being, resilience, mindfulness, negative emotions, stress, and burnout among nurses after an online mind-body based intervention during the first COVID-19 pandemic crisis. Front Psychol. 2023 Mar 13;14:848637. doi: 10.3389/fpsyg.2023.848637. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention in people with Mental Health Wellness 1, run by Universidad de Monterrey at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 6 months follow-up of Subjective Well-being (time frame: At baseline, and 6 months follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.