About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Mindful Compassion Care Program
BehavioralThe intervention is a proven effective mindfulness programme based on well-known scientific programmes such as mindfulness-based stress reduction mindfulness-based cognitive therapy and compassion focused therapy.
Treatment groups
Trial outcomes
Primary outcomes
Emotional exhaustion
Emotional exhaustion (EX) is a psychological construct that explores the perception of physical and emotional fatigue. It is characterized specifically by a lack of energy required to handle daily life and the prevalence of feelings of apathy and emotional detachment at work. EX is measured through the use of the Maslach Burnout Inventory-General Survey. The items were scored on a Likert scale from 0 (never) to 6 (everyday) (Schaufeli et al. 1996). High score is indicative of high levels of burnout.
Secondary outcomes
Personal socio-demographic information
These information will be collected by using an ad hoc schedule, addressing personal and job-related characteristics.
Professional efficacy and cynicism
Maslach Burnout Inventory-General Survey. Cynicism (5 items), which measures an indifference or a distant attitude towards your work; professional efficacy (6 items), which measures satisfaction with past and present accomplishments, and it explicitly assesses an individual's expectations of continued effectiveness at work. The items were scored on a Likert scale from 0 (never) to 6 (everyday) (Schaufeli et al. 1996). High score is indicative of high levels of burnout.
Depressive symptoms
Patient Health Questionnaire (PHQ-9) that is a nine-question self-report measure. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
Anxiety symptoms
Generalized Anxiety Disorder (GAD-7) is a self-rated questionnaire consisting of seven items that investigate the level of anxiety and worry. The GAD-7 scale score ranges from 0 to 21 points. A score between 5 and 9 points characterizes mild GAD. Between 10 and 14, moderate GAD and between 15 and 21, severe GAD.
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