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Life With Covid Since 2020: a Randomized Control Trial of a Real-time Data Collection Smartphone-based App Assessing and Treating the Covid-19 Psychological Impacts

NCT05054101 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-26

No results posted yet for this study

Summary

The COVID-19 pandemic and more specifically the confinement is an unpleasant experience for those who undergo it. Separation from loved ones, the loss of freedom, uncertainty over disease status, and boredom can, on occasion, create dramatic effects.

In fact, the pandemic and its consequences are inducing a considerable degree of fear, worry and concern in the population at large and among certain groups in particular, such as older adults, care providers and people with underlying health conditions.

If we refer back to former pandemics (SARS-CoV-1, MERS, Ebola), suicide, post-traumatic stress disorder (PTSD) and adjustment disorders have been reported, anger generated, and lawsuits brought.

The current COVID-19 pandemic is an epidemiological and psychological crisis. The enormity of living in isolation, changes in our daily lives, job loss, financial hardship and grief over the death of loved ones has the potential to affect the mental health and well-being of many.

Given the developing situation with Covid-19, policy makers urgently need evidence synthesis to produce guidance for the public and patients suffering from mental disorders such as PTSD and adjustment disorders. Therefore, it seems crucial to assess and manage the signs of anxiety, panic attacks, depression and suicide easily and at the national scale using fast, efficient and cutting-edge techniques.

Objectives :

To assess the superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from PTSD or adjustment disorders within the context of COVID-19, on the rate of responders at 6 months using the PCL-5 (PTSD Checklist for DSM-5)

The VieCovid2020 smartphone application provides lifestyle and educational advices, as well as, a real-time data collection targeted the emotional state of the user.

It will be used during 3 months in add-on to usual psychiatric intervention and psychiatric evaluations.

Conditions

Interventions

OTHER

Real-time assessment using the VieCovid2020 smartphone application

a real-time assessment using the VieCovid2020 smartphone application during the first 3 months in add-on to usual psychiatric intervention

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2023-06-15
Completion
2023-06-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05054101 on ClinicalTrials.gov