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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393818
Acronym
PsyCovid_App
Enrollment
560
Registered
2020-05-19
Start date
2020-05-05
Completion date
2020-08-24
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Burnout, Depression, Mental Health Disorder, Posttraumatic Stress Disorder

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.

Interventions

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants will be blinded, as both the intervention and the control group will receive an App with information about management of mental health problems targeted at healthcare providers. The statisticians and outcome assessors (in this case the psychologists who will undertake the pre and post intervention psychological evaluations) will also be blinded. Only the PI and a research assistance will be unblinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Depression, anxiety and stress2 weeksDepression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Secondary

MeasureTime frameDescription
Post-traumatic stress syndrome2 weeksDavidson 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.
Insomnia2 weeksInsomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)
Self Efficacy2 weeksGeneral Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026