Table 3 World Health Organization trial registration data set

Primary registry and trial identifying number

ClinicalTrials.gov; Identifier: NCT05308537

Date of registration in primary registry

1 April 2022

Secondary identifying numbers

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Source(s) of monetary or material support

No external funding will be provided.

The study will be supported by personal funding of each investigator from the University of Verona

Primary sponsor

No sponsor

Secondary sponsor(s)

No sponsor

Contact for public queries

Prof. Antonio Lasalvia, PhD, MD

telephone: + 39 045 8283911

e-mail: antonio.lasalvia@univr.it

Contact for scientific queries

Prof. Antonio Lasalvia, PhD, MD

Section of Psychiatry, Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona

Policlinico “G.B. Rossi”

P.le Scuro, 10 37134 – Verona, Italy

Public title

Evaluating a Mindful Compassion Care Program for reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic

Scientific title

The effectiveness of the Mindful Compassion Care Program (MCCP) in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial

Countries of recruitment

Italy

Health condition(s) or problem(s) studied

Psychological intervention, burnout, psychological distress, frontline hospital nurses, COVID-19 pandemic

Intervention(s)

Experimental intervention: Mindful Compassion Care Program

Control intervention: Waiting List

Key inclusion and exclusion criteria

Ages eligible for study: ≥ 18 years

Sexes eligible for study: both

Accepts healthy volunteers: no

Inclusion criteria: (1) nurses employed at Verona Academic Hospital Trust over the previous 2 years; (2) working within intensive care units, infectious disease unit, and pulmonary medicine and internal medicine units that have been converted to COVID-19 sub-intensive units; and (3) scoring above the cut-off score for the Emotional Exhaustion sub-scale (EX) of the Maslach Burnout Inventory-General Survey (MB-GS).

Exclusion criteria: (1) participation in a mindfulness-based interventions over the previous 6 months; (2) score < 2.20 in the EX subscale of the MBI-GS; and (3) currently receiving psychosocial or psychiatric treatment

Study type

Interventional

Allocation: randomized

Intervention model: parallel assignment

Masking: no blinding

Primary purpose: treatment

Date of first enrolment

September 2022

Target sample size

72

Recruitment status

Advertising

Primary outcome(s)

Change in the sub-subscale of emotional exhaustion (EX) of the Maslach Burnout Inventory-General Survey (MBI-GS) between pre-treatment and post-treatment

Key secondary outcomes

Change between pre-treatment and post-treatment on the following dimensions:

- Professional efficacy (MBI-GS)

- Cynicism (MBI-GS)

- Depressive symptoms (PHQ-9)

- Anxiety symptoms (GAD-7)

- Post-traumatic symptoms (IES-R)

- Insomnia (ISI)

- Perception of stress (PSS)

- Mindfulness skills (FFMQ)

- Evaluation of self-criticism and self-reassurance (FSCRS)