NCT04870775

Brief Summary

The aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

April 29, 2021

Last Update Submit

December 7, 2021

Conditions

Keywords

PsychopathologyCovid-19MindfulnessHospital workers

Outcome Measures

Primary Outcomes (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.

    Baseline, and 2 months

Secondary Outcomes (4)

  • Perceived Stress Scale (PSS)

    Baseline, and 2 months

  • Self-Compassion Scale (SCS)

    Baseline, and 2 months

  • Scale of Body Connection (SBC)

    Baseline, and 2 months

  • Five Facet Mindfulness Questionnaire (FFMQ)

    Baseline, and 2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The intervention administered to the experimental group will be a mindfulness training program

Behavioral: Mindfulness Training Program

Control group

NO INTERVENTION

The control group will not receive any intervention

Interventions

Mindfulness training program to reduce psychotropathological symptoms in hospital workers

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working in a hospital
  • Proficiency in the Spanish language

You may not qualify if:

  • Have severe mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose A. Puertas-Gonzalez

Granada, 18071, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Predoctoral Researcher

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 3, 2021

Study Start

May 3, 2021

Primary Completion

October 10, 2021

Study Completion

October 10, 2021

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations