MindfulnessNCT04555005
Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
A study testing Mindfulness based intervention in people with Mindfulness and COVID-19, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, COVID-19, Healthcare Worker
- What is being tested?
- Mindfulness based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2020to 26 Apr 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All frontline healthcare workers present in the ward at the time of intervention
Who cannot join
- Extreme adverse events
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Mindfulness, COVID-19, Healthcare Worker
- Being tested
- Mindfulness based intervention
- 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
Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based intervention | Other | Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak Receives: Other: Mindfulness based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: through study completion, up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start10 Mar 2020
- Primary completion26 Apr 2020
- Study completion26 Apr 2020
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 MindfulnessStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555005
- Sponsor's protocol ID
- Mind-COVID-19
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33329103
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04555005
- Acronym / sponsor ID
- Mind-COVID-19
- Conditions
- Mindfulness, COVID-19, Healthcare Worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 26 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 18 Sep 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based intervention | Other | Other: Mindfulness based interventionMindfulness based intervention for frontline healthcare workers during COVID-19 outbreak |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All frontline healthcare workers present in the ward at the time of intervention
Key exclusion criteria (1 listed)
- Extreme adverse events
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 interventionMindfulness based intervention for frontline healthcare workers during COVID-19 outbreak | Other | Mindfulness based intervention |
Primary outcome
Perceived helpfulness to reduce current stress
Time frame: 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".
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 11 Sep 2025.
- Derived from this study: PubMed 33329103Rodriguez-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.
- 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 Mindfulness and COVID-19, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 11 Sep 2025. 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 Spain. 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?
Perceived helpfulness to reduce current stress (time frame: through study completion, up to three days). 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 NCT04555005, 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 11 Sep 2025.