Randomized Controlled Trial of the Mindful Compassion Care Program in Reducing Psychological Distress Amongst Nurses During the COVID-19 Pandemic
Condition: Burnout; COVID-19
MeSH terms: COVID-19; Burnout, Psychological
Study type: Interventional

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.
    

Detailed description: 
      BACKGROUND. From the beginning of the COVID-19 pandemic, healthcare workers (HCWs) worldwide
      experienced overwork, increased health risks in the absence of clear guidelines, and the
      reorganisation of their activities. These factors, combined with exposure to a condition of
      increased mortality and a sense of uncontrollability, have led to growing incidences of
      burnout, anxiety, depressive symptoms, and a reduced investment of energy in the professional
      sphere. Nurses were amongst the HCWs most exposed to the negative psychological effects of
      the COVID-19 pandemic, particularly those working in departments most involved in the
      treatment of COVID-19 patients, such as intensive care, infectious disease, and pulmonary
      units and emergency rooms. Several studies have shown the effects of mindfulness
      interventions in reducing burnout and emotional distress among HCWs in the pre-COVID 19 era.
      Mindfulness can be defined as an awareness of present-moment thoughts, feelings, and bodily
      sensations through intentional and non-judgemental attention. It is a state of consciousness
      that allows the mind and body to build a relationship of harmony and balance, a predisposing
      element for the condition of well-being. Studies investigating the diffusion of clinical
      models based on mindfulness have allowed us to hypothesize that it can play an important role
      in emotional self-regulation. It can, therefore, be argued that mindfulness allows one to
      reduce suffering and create a healthy mind by using self-processing processes and modulating
      awareness of self and one's emotional states, behaviours, as well as relationships with
      others. The ability to manage suffering, for example of patients and caregivers, stems from
      an empathic and emotional attunement known as compassion to the suffering of the another
      person. Compassion can be defined as the awareness of one's own and others' suffering and the
      intention or motivation to alleviate it. It has been associated with the capacity to adjust
      to distressful experiences during dramatic events such as pandemics, and amongst HCWs in
      particular.

      AIMS. Studies evaluating the efficacy of mindfulness among HCWs s working during the current
      COVID-19 pandemic are rare, though some are in progress. The present project is based on the
      results of a longitudinal study that assessed the psychological impact of the COVID-19
      pandemic on HCWs at the Verona University Hospital Trust during the lockdown phase and after
      one year later. The present project proposed here aims to implement and evaluate the
      feasibility, acceptability, and effectiveness of a preliminarily tested intervention that
      integrates the most widely used and scientifically validated mindfulness protocols such as
      mindfulness-based stress reduction, mindfulness-based cognitive therapy, and compassion
      focused therapy, in a healthcare context (the Verona University Hospital Trust) during the
      COVID-19 pandemic. The purpose of the intervention is to reduce burnout and psychological
      distress among frontline nurses involved in the clinical management of COVID-19 patients. The
      study will be conducted at the Verona University Hospital Trust (Azienda Ospedaliera
      Universitaria Integrata [AOUI]), the second-largest hospital in Italy in terms of the number
      of beds and the fifth largest in terms of admissions. The trust employs 6,000 people,
      including nearly 2,000 nurses. On 17 March 2020, the Veneto regional government converted
      part of the hospital into a COVID-19 hospital. Dedicated pathways for both suspected and
      confirmed COVID-19 cases were established within the hospital, as well as in other hospital
      units located in clearly restricted areas devoted to the treatment of COVID-19 patients.

      DESIGN. Participants will be randomly assigned to one of two groups: the experimental group
      will receive the Mindful Compassion Care Program (MCCP), and the control group will be
      allocated to a waiting list (WL). The effectiveness of the experimental intervention will be
      assessed by comparing the changes in the level of burnout at the end of the treatment and
      after 1-month later. Other psychological dimensions will also be investigated (i.e., anxiety
      and depressive symptoms, post-traumatic symptoms, insomnia, perception of stress, mindfulness
      skills and evaluation of self-criticism and self-reassurance).

      Enrollment procedure: The study description and the invitation to participate will be
      published in the hospital's newsletter and will be emailed to the nurses' address by the
      Verona Hospital Trust Administration. All nurses who express an interest in participating
      will receive (via email) an information sheet containing all the project details together
      with a link to the online screening questionnaire. They will find the participant consent
      form and the consent form for the use and processing of personal data on the same page. The
      screening questionnaire will allow us to assess whether the participant meets the inclusion
      criteria. If they do, they will be added to a temporary list of candidates; if they do not,
      they will be excluded from the trial. Participants will be randomly allocated to the
      intervention or the WL control group with an allocation ratio of 1:1. Participants allocated
      to the experimental group will receive the intervention immediately after randomization, and
      those assigned to the control group will be offered the same intervention 6 months after. The
      experimental intervention will take place over 6-weeks. The pre-test, post-test, and 1-month
      follow-up will be carried out at the same time for both study groups. The trial will begin in
      April 2022. Enrolment will end as soon as the expected number is reached (36 for the
      intervention group and 36 for the control group). Before the intervention, participants
      randomly assigned to the intervention group will be divided into three subgroups consisting
      of 12 individuals. Each subgroup will follow the mindfulness courses (led by the same
      instructor) for 6 weeks. The courses will be delivered every Monday for subgroup 1, Tuesday
      for subgroup 2, and Wednesday for subgroup 3. Nurses will attend the intervention during
      working hours as part of the continuing professional education (CPE) courses provided by the
      Verona Hospital Trust Administration.

      BASELINE ASSESSMENT. Before entering the study, participants screening positive will be asked
      to provide informed consent to participate. 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).

      FOLLOW-UP ASSESSMENT. After 1 months from the end of the intervention participants will be
      re-assessed for 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).
    

Intervention name(s): Mindful Compassion Care Program
Intervention type(s): Behavioral
Intervention description(s): The 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; compassion; burnout; emotional exhaustion; COVID-19; healthcare workers; nurse