Background:

The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to healthcare workers (HCWs), who are facing heavy workloads under psychologically difficult situations.

Objective:

This trial aims to evaluate the effectiveness of a psychoeducational mobile Health (mHealth) intervention to reduce mental health problems in HCWs during the COVID-19 pandemic.

Methods:

We carried out a blinded randomized controlled trial. HCWs caring for COVID-19 patients in Spain were randomly assigned (1:1) by a computer-generated randomization sequence to the PsyCovidApp intervention (App targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control App (general recommendations about mental healthcare). Data collection was conducted telephonically at baseline and two weeks. The primary endpoint was a composite of depression, anxiety, and stress. Secondary endpoints were insomnia, burnout, posttraumatic stress, self-efficacy, depression, anxiety, and stress. Differences between groups were analyzed using general linear modeling, according to an intention-to-treat protocol.

Results:

Between 14 May and 25 July 2020, 482 HCWs were randomly assigned to PsyCovidApp (n=248) or the control App (n=234). At two weeks, complete outcome data were available for 436 (91%) HCWs. No significant differences were observed between the groups at two weeks in the primary outcome (standardized mean difference -0.04 [95% CI -0.11 to 0.04]; p=0.15) and in the rest of the outcomes. In our prespecified subgroup analyses, we observed significant (p<0.05) improvements among HCWs consuming psychotropic medications in the primary outcome, and posttraumatic stress, insomnia, anxiety, and stress. Similarly, among HCWs receiving psychotherapy, we observed improvements in the primary outcome, insomnia, anxiety, and stress.

Conclusions:

In HCWs assisting COVID-19 patients in Spain, PsyCovidApp, compared with a control App, reduced mental health problems at two weeks only among HCWs receiving psychotherapy or psychotropic medications. Clinical Trial: ClinicalTrials.gov NCT04393818