Fiol DeRoque 2021.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Baseline characteristics Mindfulness‐based mHealth intervention (PsyCovidApp Group)
Control (App) group
Overall
Included criteria: healthcare workers from any medical speciality (pneumology, internal medicine, emergency, primary care, etc) and role (physicians, nurses, nurse assistants, etc) with access to a smartphone. We included health care workers who had provided direct, face‐to‐face health care to patients with a diagnosis of infection with COVID‐19. Excluded criteria: healthcare workers who were not able to download and activate the app used to deliver the intervention during the next 10 days following the baseline assessment. Pretreatment: reported socio demographic baseline characteristics of participants randomised to the intervention group were similar to socio demographic baseline characteristics of participants randomised to the control group Compliance rate: 684 healthcare workers of which 482 participated in at least 50% of the intervention 482 > 74% Response rate: 482 of the 525 (92%) eligible participants participated Type of healthcare worker: various HCWs |
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Interventions |
Intervention characteristics Mindfulness‐based mHealth intervention (PsyCovidApp Group)
Control (App) group
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Outcomes |
DASS ‐ overall
Maslach Burnout Inventory ‐ Emotional exhaustion
Maslach Burnout Inventory ‐ Personal accomplishment
Maslach Burnout Inventory ‐ Depersonalisation
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Identification |
Sponsorship source: NR Country: Spain Setting: Hospital Comments: NR Authors name: Maria Antònia Fiol‐DeRoque Institution: Health Research Institute of the Balearic Islands, Palma de Mallorca, Spain Email: mariajesus.serranoripoll@ssib.es Address: Maria Jesús Serrano‐Ripoll, PhD Health Research Institute of the Balearic Islands Edificio S, Hospital Universitario Son Espases Carretera de Valldemossa Palma de Mallorca, 07120 Spain Time period: 2020 |
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Notes | MBI‐EE included in analysis 1.1 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned (1:1) to receive the PsyCovidApp intervention or the control app over two weeks by a designated researcher" Using a computer‐generated sequence of random numbers create by Internet relay chat. |
Allocation concealment (selection bias) | Low risk | Randomization done by a designated researcher who was not involved in data collection or analysis. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Health care workers were blinded to group allocation (as both groups received an app) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Participants, the outcome data collectors and trial statisticians were unaware of the treatment allocation." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up less than 20%. 436 of the 482 randomized participants had complete two‐week outcome data. |
Selective reporting (reporting bias) | Low risk | https://clinicaltrials.gov/ct2/show/NCT04393818 No differences between study and registration of the protocol |
Other bias | Low risk | No indication of other source of bias |