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

September 9, 2020 updated by: Fundació d'investigació Sanitària de les Illes Balears

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma De Mallorca, Balearic Islands, Spain, 07002
        • Ignacio Ricci-Cabello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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), work environment, and social support.
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.
SHAM_COMPARATOR: Control App
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, anxiety and stress
Time Frame: 2 weeks
Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-traumatic stress syndrome
Time Frame: 2 weeks
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
Insomnia
Time Frame: 2 weeks
Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)
2 weeks
Self Efficacy
Time Frame: 2 weeks
General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació d'investigació Sanitària de les Illes Balears

Collaborators

Hospital Son Espases
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Andalusian School of Public Health
Hospital Miguel Servet
Universidad de las Islas Baleares

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2020

Primary Completion (ACTUAL)

August 24, 2020

Study Completion (ACTUAL)

August 24, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Intervention App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe