Effect of a mobile‐based intervention on mental health in frontline healthcare workers against COVID‐19: Protocol for a randomized controlled trial
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Abstract
Aim
To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness‐based approaches on the mental health of healthcare workers at the frontline against COVID‐19 in Spain.
Design
We will carry out a two‐week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention.
Methods
The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID‐19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS‐21 questionnaire—primary endpoint), insomnia (ISI), burnout (MBI‐HSS), post‐traumatic stress disorder (DTS), and self‐efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.
Discussion
Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context.
Impact
Despite the lack of solid evidence about their effectiveness, mobile‐based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.
Clinical trial registration
NCT04393818 (ClinicalTrials.gov identifier).
Approved funding
May 2020.
Article activity feed
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SciScore for 10.1101/2020.11.03.20225102: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Limitations: The study has also some limitations. First, the two weeks follow-up period may be not enough to detect clinically meaningful differences in the selected outcomes. Although adherence to mHealth apps generally …
SciScore for 10.1101/2020.11.03.20225102: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Limitations: The study has also some limitations. First, the two weeks follow-up period may be not enough to detect clinically meaningful differences in the selected outcomes. Although adherence to mHealth apps generally decrease overtime34, and two weeks is enough to access to all the contents of the PsyCovidApp intervention, a longer period of time may be needed to produce the desired positive effects on mental health. Second, restricting the study to HCWs with a smartphone and able to download and use mobile Apps may cause a selection bias which could reduce the generalizability of our results. This is a common limitation of mHealth trials, and which is unlikely to significantly affect the results of our study, since Spain is currently the country with higher smartphone use rates in the world, with 98% of users20.Third, the mental health of the participants will not be evaluated through a clinical interview, but rather using instruments indicated for symptomatology assessment rather than for clinical diagnosis. Fourth, we will not restrict our sample to HCWs with mental health problems at baseline. Including a large proportion of participants with no (or minor) mental health problems in our study may limit our ability to observe mental health improvements. Fifth, high dropout rates and low intervention adherence are common limitations of trials of low-intensity interventions, such as the one proposed in our study. Sixth, our ability to conduct the planned subgroup analyses...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04393818 Completed Mobile Phone Based Intervention to Protect Mental Health in … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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