Clinical trial NCT04393818: Mobile Phone Based Intervention to Protect Mental Health in Healthcare Workers at Frontline Against COVID19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Health Disorder
Depression
Posttraumatic Stress Disorder
Burnout
Anxiety Disorders
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
Collaborators: name: Universidad de las Islas Baleares
name: Hospital Miguel Servet
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Andalusian School of Public Health
name: Hospital Son Espases
First posted: 2020-05-19
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Depression, anxiety and stress
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-traumatic stress syndrome
timeFrame: 2 weeks
measure: Insomnia
timeFrame: 2 weeks
measure: Self Efficacy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Ignacio Ricci-Cabello
state: Balearic Islands
Study officials:
References:
citation: Fiol-DeRoque MA, Serrano-Ripoll MJ, Jimenez R, Zamanillo-Campos R, Yanez-Juan AM, Bennasar-Veny M, Leiva A, Gervilla E, Garcia-Buades ME, Garcia-Toro M, Alonso-Coello P, Pastor-Moreno G, Ruiz-Perez I, Sitges C, Garcia-Campayo J, Llobera-Canaves J, Ricci-Cabello I. A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 18;9(5):e27039. doi: 10.2196/27039.
citation: Serrano-Ripoll MJ, Ricci-Cabello I, Jimenez R, Zamanillo-Campos R, Yanez-Juan AM, Bennasar-Veny M, Sitges C, Gervilla E, Leiva A, Garcia-Campayo J, Garcia-Buades ME, Garcia-Toro M, Pastor-Moreno G, Ruiz-Perez I, Alonso-Coello P, Llobera J, Fiol-deRoque MA. Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial. J Adv Nurs. 2021 Jun;77(6):2898-2907. doi: 10.1111/jan.14813. Epub 2021 Mar 6.