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

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ClinicalTrials.gov Identifier: NCT04393818
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
Universidad de las Islas Baleares
Hospital Universitario Miguel Servet
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Andalusian School of Public Health
Hospital Son Espases
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears

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.

Condition or disease Intervention/treatment Phase
Mental Health Disorder Depression Posttraumatic Stress Disorder Burnout Anxiety Disorders Behavioral: Intervention App Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : August 24, 2020
Actual Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Depression, anxiety and stress [ Time Frame: 2 weeks ]
    Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)


Secondary Outcome Measures :
  1. 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. Insomnia [ Time Frame: 2 weeks ]
    Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

  3. Self Efficacy [ Time Frame: 2 weeks ]
    General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393818


Locations
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Spain
Ignacio Ricci-Cabello
Palma De Mallorca, Balearic Islands, Spain, 07002
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Universidad de las Islas Baleares
Hospital Universitario Miguel Servet
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Andalusian School of Public Health
Hospital Son Espases
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Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT04393818    
Other Study ID Numbers: COVID-19/06
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Stress Disorders, Post-Traumatic
Mental Disorders
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders