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Mental Health DisorderPhase 3PsyCovid_AppNCT04393818

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

A Phase 3 study testing Intervention App in people with Mental Health Disorder and Depression, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Intervention App
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
560 participants
Where
1 siteSpain
Study dates
5 May 2020to 24 Aug 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.).

Who cannot join

  • We will exclude healthcare workers not able to use, or with no access, to a smartphone.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Ignacio Ricci-Cabello

    Palma de Mallorca, Balearic Islands, 07002

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Intervention App
Medical subject headings
Mental Disorders, Depression, Stress Disorders, Post-Traumatic, Burnout, Psychological, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention AppBehavioural

    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.

Study groups in NCT04393818
Study groupRoleWhat they receive
Intervention AppExperimentalParticipants 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.
Receives: Behavioral: Intervention App
Control AppSham comparatorParticipants 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.
Receives: Behavioral: Intervention App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression, anxiety and stress

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

    Measured: 2 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 2 weeks

  2. Insomnia

    Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

    Measured: 2 weeks

  3. Self Efficacy

    General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start5 May 2020
  3. Primary completion24 Aug 2020
  4. Study completion24 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393818
Sponsor's protocol ID
COVID-19/06
Acronym
PsyCovid_App
Status last verified
Aug 2020
First submitted
18 May 2020
Last updated
10 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33909587

  • 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.

    PubMed 33675247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intervention App in people with Mental Health Disorder and Depression, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression, anxiety and stress (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393818, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.

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