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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Spain1 site
  • Jose A. Puertas-Gonzalez

    Granada, 18071

Other trials in Spain

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 groups in NCT04870775
Study groupRoleWhat they receive
Experimental groupExperimentalThe intervention administered to the experimental group will be a mindfulness training program
Receives: Behavioral: Mindfulness Training Program
Control groupNo interventionThe control group will not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted3 May 2021
  2. Study start3 May 2021
  3. Primary completion10 Oct 2021
  4. Study completion10 Oct 2021

Resources

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)
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

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.

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