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. 2023 May 12;2023(5):CD002892. doi: 10.1002/14651858.CD002892.pub6

Fiol DeRoque 2021.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
Mindfulness‐based mHealth intervention (PsyCovidApp Group)
  • Age (mean ± SD): 42 ± 11

  • Sex (N (% female)): 210 (85%)

  • Sample size: 248

  • Years of experience (mean ± SD): NR


Control (App) group
  • Age (mean ± SD): 40 ± 9.6

  • Sex (N (% female)): 191 (82%)

  • Sample size: 234

  • Years of experience (mean ± SD): NR


Overall
  • Age (mean ± SD): 41.4 ± 10.4

  • Sex (N (% female)): 401 (83%)

  • Sample size: 482

  • Years of experience (mean ± SD): NR


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
Interventions Intervention characteristics
Mindfulness‐based mHealth intervention (PsyCovidApp Group)
  • Type of the intervention: Intervention type 1 ‐ to focus one’s attention on the experience of stress

  • Description of the intervention: The self‐managed psycho‐educational intervention, based on cognitive‐behavioural therapy and mindfulness approaches, included written and audiovisual content targeting four areas: emotional skills, healthy lifestyle behaviour, work stress and burnout, and social support. Additionally, the intervention included daily prompts (notifications) that included brief questionnaires to monitor mental health status, followed by short messages offering tailored information and resources based on the participants ´responses.

  • The number of sessions: NR

  • Duration of each session on average: NR

  • Duration of the entire intervention: two weeks

  • Duration of the entire intervention short vs long: short

  • Intervention deliverer: An App developed by group of psychologists, psychiatrists and experts in healthy lifestyle promotion (all co‐authors of the study)

  • Intervention form: Individual


Control (App) group
  • Type of the intervention: Control App

  • Description of the intervention: Brief written information about the mental health care of health care workers during the COVID‐19 pandemic

  • The number of sessions: NA

  • Duration of each session on average: NA

  • Duration of the entire intervention: two weeks

  • Duration of the entire intervention short vs long: short

  • Intervention deliverer: An App developed by group of psychologists, psychiatrists and experts in healthy lifestyle promotion (all co‐authors of the study)

  • Intervention form: Individual

Outcomes DASS ‐ overall
  • Outcome type: Continuous Outcome


Maslach Burnout Inventory ‐ Emotional exhaustion
  • Outcome type: Continuous Outcome


Maslach Burnout Inventory ‐ Personal accomplishment
  • Outcome type: Continuous Outcome


Maslach Burnout Inventory ‐ Depersonalisation
  • Outcome type: Continuous Outcome

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
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