Actively Recruiting

Phase Not Applicable
Age: 25Years - 65Years
All Genders
NCT05308537

Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic

Led by Universita di Verona · Updated on 2024-11-25

33

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. A parallel-group randomized controlled trial will assess the feasibility, acceptability, and efficacy of a mindfulness and compassion-focused programme on frontline nurses who had been working during the COVID-19 pandemic. Seventy-two participants will be divided equally into an intervention group and a control group. Primary outcome will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS). Secondary outcomes will be measured by the Cynicism and Professional Efficacy subscales of the MBI-GS; the Patient Health Questionnaire (PHQ-9); the Generalized Anxiety Disorder (GAD-7); the Insomnia Severity Index (ISI); the Impact of Stressful Events (IES-R); the Perceived Stress Scale (PSS); the Five Facet Mindfulness Questionnaire (FFMQ); and the Forms of Self-Criticising/attacking and Self-Reassuring Scale (FSCRS). The study aims to fill a gap in the literature and present a scientifically validated intervention for those healthcare professionals most exposed to the stressful conditions of working during the COVID-19 pandemic.

CONDITIONS

Official Title

Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic

Who Can Participate

Age: 25Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a nurse employed at Verona University Hospital Trust for the past two years
  • Work in intensive care, infectious disease, pulmonary medicine, or internal medicine units converted to COVID-19 sub-intensive units
  • Have a score equal to or greater than 2.20 on the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS) according to Italian norms
Not Eligible

You will not qualify if you...

  • Participated in mindfulness-based interventions within the previous 6 months
  • Have a score less than 2.20 on the Emotional Exhaustion subscale of the MBI-GS
  • Are currently receiving psychosocial or psychiatric treatment
  • Participants assigned to the waiting list must not participate in mindfulness courses offered elsewhere

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Università di Verona

Verona, Italia, Italy, 37129

Actively Recruiting

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Research Team

A

Antonio Lasalvia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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