- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870775
Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic.
Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18071
- Jose A. Puertas-Gonzalez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Working in a hospital
- Proficiency in the Spanish language
Exclusion Criteria:
- Have severe mental disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental group
The intervention administered to the experimental group will be a mindfulness training program
|
Mindfulness training program to reduce psychotropathological symptoms in hospital workers
|
|
NO_INTERVENTION: Control group
The control group will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, and 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS)
Time Frame: Baseline, and 2 months
|
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)
|
Baseline, and 2 months
|
|
Self-Compassion Scale (SCS)
Time Frame: Baseline, and 2 months
|
The SCS is a 26-item self-reporting questionnaire with a 5-point Likert response format (from 1 = almost never to 5 = almost always).
|
Baseline, and 2 months
|
|
Scale of Body Connection (SBC)
Time Frame: Baseline, and 2 months
|
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).
|
Baseline, and 2 months
|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline, and 2 months
|
The scale has 39 items and is answered with a 5-point Likert scale ranging from 1 (never) to 5 (always).
|
Baseline, and 2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GESTASTRESS-Covid
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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