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

Depression Clinical Trial

— PsyCovid_App  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393818
• Other study ID #: COVID-19/06
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2020
• Est. completion date: August 24, 2020

Study information

• Verified date: August 2020
• Source: Fundació d'investigació Sanitària de les Illes Balears
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Burnout
• Depression
• Disease
• Mental Disorders
• Mental Health Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
Spain	Ignacio Ricci-Cabello	Palma De Mallorca	Balearic Islands

Sponsors (6)

Lead Sponsor	Collaborator
Fundació d'investigació Sanitària de les Illes Balears	Andalusian School of Public Health, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Son Espases, Hospital Universitario Miguel Servet, Universidad de las Islas Baleares

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression, anxiety and stress	Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)	2 weeks
Secondary	Post-traumatic stress syndrome	Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.	2 weeks
Secondary	Insomnia	Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)	2 weeks
Secondary	Self Efficacy	General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)	2 weeks