Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Dist… (NCT05308537) | Clinical Trial Compass
RecruitingNot Applicable
Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic
Italy33 participantsStarted 2023-01-27
Plain-language summary
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.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be included in the study, a participants will have to be:
* a nurse employed at AOUI for the past two years;
* working within intensive care units, infectious disease unit, pulmonary medicine and internal medicine units that have been converted to COVID-19 sub-intensive units;
* scoring above the cut-off score for the Emotional Exhaustion sub-scale (EX) of the MBI-GS (equal to or greater than 2.20) in accordance with Italian norms
Exclusion Criteria:
Respondents will be excluded if they:
* have participated in mindfulness-based interventions in the previous 6 months;
* show a score \< 2.20 in the EX subscale of the MBI-GS;
* are receiving psychosocial or psychiatric treatment. Participants allocated to the WL will be requested not to participate in a mindfulness course offered elsewhere.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Emotional exhaustion
Timeframe: Change from baseline at 1 month follow-up