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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Mental Health Disorder
- Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Enrollment
- 560
- Locations
- 1
- Primary Endpoint
- Depression, anxiety and stress
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Depression, anxiety and stress
Time Frame: 2 weeks
Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)
Secondary Outcomes
- Self Efficacy(2 weeks)
- Post-traumatic stress syndrome(2 weeks)
- Insomnia(2 weeks)