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

NCT05308537 | Recruiting DMC

• 1 other identifier: 3717CESC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burnout; COVID-19

Keywords

mindfulness; compassion; burnout; emotional exhaustion; COVID-19; healthcare workers; nurse

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 1 month follow-up

Secondary Outcomes (9)

• Personal socio-demographic information

  Baseline

• Professional efficacy and cynicism

  Change from baseline at 1 month follow-up

• Depressive symptoms

  Change from baseline at 1 month follow-up

• Anxiety symptoms

  Change from baseline at 1 month follow-up

• Insomnia

  Change from baseline at 1 month follow-up

Study Arms (2)

Mindful Compassion Care Program

EXPERIMENTAL

The MCCP comprises six regular 1 hour and 30-minute sessions and 1 all-day class lasting 4 hours and 30 minutes.

Behavioral: Mindful Compassion Care Program

Waiting List

NO INTERVENTION

Interventions

Mindful Compassion Care Program BEHAVIORAL

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.

Mindful Compassion Care Program

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Università di Verona

Verona, Italia, 37129, Italy

RECRUITING

Related Publications (7)

• Lasalvia A, Amaddeo F, Porru S, Carta A, Tardivo S, Bovo C, Ruggeri M, Bonetto C. Levels of burn-out among healthcare workers during the COVID-19 pandemic and their associated factors: a cross-sectional study in a tertiary hospital of a highly burdened area of north-east Italy. BMJ Open. 2021 Jan 17;11(1):e045127. doi: 10.1136/bmjopen-2020-045127.

  PMID: 33455940 BACKGROUND

• Lasalvia A, Bonetto C, Porru S, Carta A, Tardivo S, Bovo C, Ruggeri M, Amaddeo F. Psychological impact of COVID-19 pandemic on healthcare workers in a highly burdened area of north-east Italy. Epidemiol Psychiatr Sci. 2020 Dec 17;30:e1. doi: 10.1017/S2045796020001158.

  PMID: 33331255 BACKGROUND

• Lasalvia A, Bodini L, Amaddeo F, Porru S, Carta A, Poli R, Bonetto C. The Sustained Psychological Impact of the COVID-19 Pandemic on Health Care Workers One Year after the Outbreak-A Repeated Cross-Sectional Survey in a Tertiary Hospital of North-East Italy. Int J Environ Res Public Health. 2021 Dec 19;18(24):13374. doi: 10.3390/ijerph182413374.

  PMID: 34948981 BACKGROUND

• La Torre G, Raffone A, Peruzzo M, Calabrese L, Cocchiara RA, D'Egidio V, Leggieri PF, Dorelli B, Zaffina S, Mannocci A, Yomin Collaborative Group. Yoga and Mindfulness as a Tool for Influencing Affectivity, Anxiety, Mental Health, and Stress among Healthcare Workers: Results of a Single-Arm Clinical Trial. J Clin Med. 2020 Apr 7;9(4):1037. doi: 10.3390/jcm9041037.

  PMID: 32272758 BACKGROUND

• Matos M, McEwan K, Kanovsky M, Halamova J, Steindl SR, Ferreira N, Linharelhos M, Rijo D, Asano K, Marquez MG, Gregorio S, Vilas SP, Brito-Pons G, Lucena-Santos P, da Silva Oliveira M, de Souza EL, Llobenes L, Gumiy N, Costa MI, Habib N, Hakem R, Khrad H, Alzahrani A, Cheli S, Petrocchi N, Tholouli E, Issari P, Simos G, Lunding-Gregersen V, Elklit A, Kolts R, Kelly AC, Bortolon C, Delamillieure P, Paucsik M, Wahl JE, Zieba M, Zatorski M, Komendzinski T, Zhang S, Basran J, Kagialis A, Kirby J, Gilbert P. Compassion Protects Mental Health and Social Safeness During the COVID-19 Pandemic Across 21 Countries. Mindfulness (N Y). 2022;13(4):863-880. doi: 10.1007/s12671-021-01822-2. Epub 2022 Jan 4.

  PMID: 35003380 BACKGROUND

• Cheli S, De Bartolo P, Agostini A. Integrating mindfulness into nursing education: A pilot nonrandomized controlled trial. Int J Stress Manag. 2020;27(1):93.

  BACKGROUND

• Bodini L, Bonetto C, Cheli S, Del Piccolo L, Rimondini M, Rossi A, Carta A, Porru S, Amaddeo F, Lasalvia A. Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):734. doi: 10.1186/s13063-022-06666-2.

  PMID: 36056401 DERIVED

MeSH Terms

Conditions

Burnout, Psychological; COVID-19; Emotional Exhaustion

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Lasalvia

CONTACT

+39 045 8283901; antonio.lasalvia@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 4, 2022
• Study Start: January 27, 2023
• Primary Completion: February 19, 2023
• Study Completion: November 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

IT (1)