Official Title
A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial
Brief Summary

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

Detailed Description

Healthcare workers (HCWs) commonly present high levels of anxiety, depression, posttraumatic
stress, acute disorder and burnout, both during and after viral outbreaks. Although
educational and multifaceted interventions might mitigate the development of mental health
problems, the certainty on the evidence is very low. The aim of this double-blinded
randomized clinical trial is to examine the impact of a mobile phone based intervention to
prevent and manage mental health problems in healthcare workers at the frontline against
COVID-19 in Spain.

The trial will include HCWs having provided healthcare to patients with COVID19 in a
healthcare centre (any setting) in Spain during the viral outbreak in Spain. Professionals
from any medical speciality and role (doctors, nurses, nurse assistance, etc.) with access to
a smartphone will be included. The investigators will collect expressions of interest via
dissemination of the study through social media and key stakeholders (hospital managers,
scientific societies and professional colleges). A team of psychologists will contact (via
telephone) potential participants to confirm they meet the eligibility criteria (described
above), obtain signed consent (audio-recorded), and carry out a psychological
(pre-intervention) evaluation. The participants will then be randomly allocated to receive a
fully functional App (full intervention) or an App with brief generic recommendations about
mental health (control intervention). A post-intervention psychological assessment will be
undertaken after two weeks. The primary outcome will be symptomatology of depression, anxiety
or stress. Secondary outcomes will include posttraumatic stress, burnout, insomnia, and
self-efficacy. After the two weeks follow-up, all participants allocated to the control
intervention will be offered the full intervention.

Completed
Mental Health Disorder
Depression
Posttraumatic Stress Disorder
Burnout
Anxiety Disorders

Behavioral: Intervention App

Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep disorders), work environment, and social support.

Eligibility Criteria

Inclusion Criteria:

Healthcare workers having provided healthcare to patients with COVID19 in a healthcare
centre (any setting) during the viral outbreak in Spain.

We will include professionals from any medical speciality and role (doctors, nurses, nurse
assistance, etc.).

Exclusion Criteria:

We will exclude healthcare workers not able to use, or with no access, to a smartphone.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Ignacio Ricci-Cabello
Palma De Mallorca, Balearic Islands, Spain

Fundació d'investigació Sanitària de les Illes Balears
NCT Number
MeSH Terms
Anxiety Disorders
Stress Disorders, Post-Traumatic
Mental Disorders