Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic.

December 7, 2021 updated by: Jose A. Puertas-Gonzalez, Universidad de Granada

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Granada, Spain, 18071
        • Jose A. Puertas-Gonzalez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Working in a hospital
  • Proficiency in the Spanish language

Exclusion Criteria:

  • Have severe mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 3, 2021

Primary Completion (ACTUAL)

October 10, 2021

Study Completion (ACTUAL)

October 10, 2021

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (ACTUAL)

May 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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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