Mobile Phone Based Intervention to Protect Mental Health in Healthcare Workers at Frontline Against COVID19 (PsyCovid_App)

Fundació d'investigació Sanitària de les Illes Balears

Status and phase: Completed; Phase 3

Conditions: Posttraumatic Stress Disorder; Mental Health Disorder; Burnout; Depression; Anxiety Disorders

Treatments: Behavioral: Intervention App

Study type: Interventional

Funder types: Other

Identifiers

NCT04393818

COVID-19/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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560 participants in 2 patient groups

Intervention App

Experimental group

Description:

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), work environment, and social support.

Treatment:

Behavioral: Intervention App

Control App

Sham Comparator group

Description:

Participants allocated to the control App will receive access to a a fully operational mobile phone App with limited contents about management and prevention of mental health problems. Although this group will also receive psychoeducation, the content will be reduced to general, written recommendations.

Treatment:

Behavioral: Intervention App