PsychopathologyNCT04870775
Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic.
A study testing Mindfulness Training Program in people with Psychopathology, run by Universidad de Granada at 1 site in Spain.
Trial summary
The aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychopathology
- What is being tested?
- Mindfulness Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2021to 10 Oct 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working in a hospital
- Proficiency in the Spanish language
Who cannot join
- Have severe mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic: A Randomised Controlled Trial
The aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training.
Read the detailed description
In the face of the recent health crisis, one group vulnerable to psychological consequences has been the hospital workers who have worked on the front line during the COVID-19 pandemic.
It is expected that subjects participating in Mindfulness training will decrease their psychopathological symptoms more than the control group.
The programa will be held in 8 sessions (1 per week) as follows:
SESSION 1:
Welcome Brief opening practice with anchoring or focus options. Presentation of mindfulness, what it is and what it is not, definition and available scientific evidence.
Guided reflection on what brought the people here. Introduction of participants and teacher. Standing yoga postures. Raisin meditation. Body scan practice Presentation of home practice Brief closing practice
SESSION 2:
Brief opening practice. Standing yoga postures. Body scanner practice Dialogue on the practices, in small groups first and then in the large group. Exercise of the 9 points: conditioning and creative response. Attentional photo sitting meditation. Presentation of the home practice Brief closing practice
SESSION 3:
Brief opening practice Meditation with attention to an attentional focus. Yoga postures on the floor Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of pleasant events, paying attention to how it has registered in the form of bodily sensations, thoughts and emotions.
Presentation of the home practice Brief closing practice
SESSION 4:
Brief opening practice Standing yoga postures Sitting meditation with attention to the unwanted, offering the option to pendulum, from unpleasantness to attentional focus.
Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of unpleasant events and connect the unpleasant experience with stress.
Brief explanation of stress physiology and reactivity. Presentation of home practice Brief closing practice
SESSION 5:
Brief opening practice. Standing yoga postures. Complete meditation alternating different focuses of attention to end with open awareness.
Dialogue in small groups and then in the common room about the experience of the practices, reflection on being in the middle of the course (achievements, expectations, challenges...).
Introduce mindfulness in any of the phases of the habit loop and in moments of reactivity. Concept of mindful pause.
Presentation of home practice Brief closing practice
SESSION 6:
Brief opening practice. Standing yoga postures. Full seated meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the practices, introducing reflections on engagement with the practice and its effects and challenges.
Guided reflection on a difficult communication situation and interactive dialogue from there.
Presentation of home practice Brief closing practice
SESSION 7:
Brief opening practice. Movement practice: encouraging simplicity and exploration of boundaries. Participants are invited to guide some of them.
Sitting meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the day's practice.
Reflection on how people relate to their environment and the choices people make around technology, social networking, media and what effects those choices have.
Presentation of home practice Brief closing practice
SESSION 8:
Brief opening practice. Body scanning practice Small group discussion and then in the common room about the home practice. Writing a letter to the "future self" after reflection on what the program is entailing.
Resources to continue with "the rest of your life", next steps. Group sharing of global experiences with the program Brief closing practice
RETREAT DAY In addition to the 8 sessions, a small silent retreat is held on a Saturday, which is a day of intensive practice (approximately 8 hours). On this day consecutive practices are performed, including some different sitting meditation such as mountain meditation, loving-kindness or lake meditation.
- Conditions
- Psychopathology
- Being tested
- Mindfulness Training Program
- Keywords
- Psychopathology, Covid-19, Mindfulness, Hospital workers
- 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 Training ProgramBehavioural
Mindfulness training program to reduce psychotropathological symptoms in hospital workers
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention administered to the experimental group will be a mindfulness training program Receives: Behavioral: Mindfulness Training Program |
| Control group | No intervention | The control group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms Checklist 90 Revised (SCL-90-R)
This is a 90-item scale scored using a 5-point Likert scale from 0 (never) to 4 (extremely). This instrument is used to assess 9 dimensions: Somatization, Obsession-compulsion, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The scale also has 7 extra items distributed among 3 global indexes of distress: the GSI, which measures overall psychological distress; the PSDI, which is used to measure the intensity of symptoms; and Positive Symptom Total, used to measure the number of self-reported symptoms. Using the author´s instructions, the scores are transformed to percentiles (0-100). Percentiles ≥ 70 represent clinical symptoms in any of the subscale of this instrument.
Measured: Baseline, and 2 months
Secondary outcomes (4)
Perceived Stress Scale (PSS)
The PSS provides information on the perception of general stress during the preceding month. It consists on 14 items scores on a 5-point Likert scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Scores range from 0-56 (higher scores represent higher levels of stress)
Measured: Baseline, and 2 months
Self-Compassion Scale (SCS)
The SCS is a 26-item self-reporting questionnaire with a 5-point Likert response format (from 1 = almost never to 5 = almost always).
Measured: Baseline, and 2 months
Scale of Body Connection (SBC)
The SBC is a 20-item scale involving two distinct dimensions: Body Awareness and Bodily Dissociation. Rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (all the time).
Measured: Baseline, and 2 months
Five Facet Mindfulness Questionnaire (FFMQ)
The scale has 39 items and is answered with a 5-point Likert scale ranging from 1 (never) to 5 (always).
Measured: Baseline, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start3 May 2021
- Primary completion10 Oct 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychopathologyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose A. Puertas-Gonzalez, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870775
- Sponsor's protocol ID
- GESTASTRESS-Covid
- Status last verified
- Dec 2021
- First submitted
- 29 Apr 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04870775
- Acronym / sponsor ID
- GESTASTRESS-Covid
- Conditions
- Psychopathology
- Keywords
- Psychopathology, Covid-19, Mindfulness, Hospital workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 3 May 2021 (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 aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training.
Detailed description
In the face of the recent health crisis, one group vulnerable to psychological consequences has been the hospital workers who have worked on the front line during the COVID-19 pandemic.
It is expected that subjects participating in Mindfulness training will decrease their psychopathological symptoms more than the control group.
The programa will be held in 8 sessions (1 per week) as follows:
SESSION 1:
Welcome Brief opening practice with anchoring or focus options. Presentation of mindfulness, what it is and what it is not, definition and available scientific evidence.
Guided reflection on what brought the people here. Introduction of participants and teacher. Standing yoga postures. Raisin meditation. Body scan practice Presentation of home practice Brief closing practice
SESSION 2:
Brief opening practice. Standing yoga postures. Body scanner practice Dialogue on the practices, in small groups first and then in the large group. Exercise of the 9 points: conditioning and creative response. Attentional photo sitting meditation. Presentation of the home practice Brief closing practice
SESSION 3:
Brief opening practice Meditation with attention to an attentional focus. Yoga postures on the floor Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of pleasant events, paying attention to how it has registered in the form of bodily sensations, thoughts and emotions.
Presentation of the home practice Brief closing practice
SESSION 4:
Brief opening practice Standing yoga postures Sitting meditation with attention to the unwanted, offering the option to pendulum, from unpleasantness to attentional focus.
Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of unpleasant events and connect the unpleasant experience with stress.
Brief explanation of stress physiology and reactivity. Presentation of home practice Brief closing practice
SESSION 5:
Brief opening practice. Standing yoga postures. Complete meditation alternating different focuses of attention to end with open awareness.
Dialogue in small groups and then in the common room about the experience of the practices, reflection on being in the middle of the course (achievements, expectations, challenges...).
Introduce mindfulness in any of the phases of the habit loop and in moments of reactivity. Concept of mindful pause.
Presentation of home practice Brief closing practice
SESSION 6:
Brief opening practice. Standing yoga postures. Full seated meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the practices, introducing reflections on engagement with the practice and its effects and challenges.
Guided reflection on a difficult communication situation and interactive dialogue from there.
Presentation of home practice Brief closing practice
SESSION 7:
Brief opening practice. Movement practice: encouraging simplicity and exploration of boundaries. Participants are invited to guide some of them.
Sitting meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the day's practice.
Reflection on how people relate to their environment and the choices people make around technology, social networking, media and what effects those choices have.
Presentation of home practice Brief closing practice
SESSION 8:
Brief opening practice. Body scanning practice Small group discussion and then in the common room about the home practice. Writing a letter to the "future self" after reflection on what the program is entailing.
Resources to continue with "the rest of your life", next steps. Group sharing of global experiences with the program Brief closing practice
RETREAT DAY In addition to the 8 sessions, a small silent retreat is held on a Saturday, which is a day of intensive practice (approximately 8 hours). On this day consecutive practices are performed, including some different sitting meditation such as mountain meditation, loving-kindness or lake meditation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Mindfulness Training ProgramThe intervention administered to the experimental group will be a mindfulness training program |
| Control group | No intervention | –The control group will not receive any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Working in a hospital
- Proficiency in the Spanish language
Key exclusion criteria (1 listed)
- Have severe mental disorders.
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 Training ProgramMindfulness training program to reduce psychotropathological symptoms in hospital workers | Behavioural | Experimental group |
Primary outcome
Symptoms Checklist 90 Revised (SCL-90-R)
Time frame: Baseline, and 2 months
This is a 90-item scale scored using a 5-point Likert scale from 0 (never) to 4 (extremely). This instrument is used to assess 9 dimensions: Somatization, Obsession-compulsion, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The scale also has 7 extra items distributed among 3 global indexes of distress: the GSI, which measures overall psychological distress; the PSDI, which is used to measure the intensity of symptoms; and Positive Symptom Total, used to measure the number of self-reported symptoms. Using the author´s instructions, the scores are transformed to percentiles (0-100). Percentiles ≥ 70 represent clinical symptoms in any of the subscale of this instrument.
4 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Baseline, and 2 months
Self-Compassion Scale (SCS)
Time frame: Baseline, and 2 months
Scale of Body Connection (SBC)
Time frame: Baseline, and 2 months
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline, and 2 months
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 8 Dec 2021.
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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 Training Program in people with Psychopathology, run by Universidad de Granada 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 2 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 8 Dec 2021. 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?
Symptoms Checklist 90 Revised (SCL-90-R) (time frame: Baseline, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2021; AzTrials last refreshed its copy on 30 Oct 2026.