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 (VieCovid2020)

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.

Study Overview

• Status: Withdrawn
• Conditions: PTSD
• Intervention / Treatment: Other: Real-time assessment using the VieCovid2020 smartphone application

Detailed Description

Design of the study :

Multicentric randomized controlled superiority trial with 2 parallel arms. The randomization will be a various-sized block randomization, stratified by centre and by co-treatment (=usual psychiatric intervention) prescribed at baseline before randomisation: selective serotonin reuptake inhibitors (SSRI) alone or SSRI in combination to eye movement desensitization and reprocessing (EMDR), cognitive behavioural therapy (CBT) or reconsolidation blockade.

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)

Every patient will be randomized between:

• usual psychiatric intervention alone and psychiatric evaluations at 5 following time points (day 1, 1 month, 3 months, 6 months and 12 months) (control arm) or
• a real-time assessment using the VieCovid2020 smartphone application during the first 3 months in add-on to usual psychiatric intervention and psychiatric evaluations at 5 following time points (day 1; 1 month; 3 months, 6 months and 12 months) (intervention arm)

Use of the VieCovid2020 smartphone application and psychiatric evaluations at 5 following time points are added by the research.

Population :

Volunteers suffering from PTSD or adjustment disorders will be included within the study.

Application :

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.

Expected benefits :

A potential reduction of acute and chronic stress is expected among users of the application in particular with the set of lifestyle and educational advices proposed every week.

In the COVID-19 pandemic context, the expected benefits for society is to contribute to reduce the number of patients suffering from PTSD or adjustment disorders.

850 patients are expected and 18 sites in France.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria :

• PTSD or adjustment disorders criteria according to DSM-5 and MINI criteria within the context of COVID-19 trauma exposure and economic consequences;
• patients with a PCL-5 score higher than 33;
• patient treated or who will be treated by the following treatments: SSRIs alone or SSRIs in combination to CBTs, EMDR or reconsolidation blockade
• able to download and use an app, with a correct internet connection (owner of a smartphone)
• Affiliation to a French social security system (recipient or assign) excluding AME
• written consent to participate in the study;

Exclusion criteria :

• age lower than 18, without any upper age limit;
• suicidal risk using MINI;
• non-French speaker;
• guardianship curatorship and person deprived of their liberty by judicial decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VieCovid2020 smartphone application; The VieCovid2020 smartphone application in add-on to usual psychiatric intervention	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
Placebo Comparator: Usual psychiatric intervention; Usual psychiatric intervention alone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority of the VieCovid2020 smartphone app	To assess the superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from adjustments disorders or PTSD within the context of COVID-19, on the rate of responders at 6 months on the PCL-5.	6 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User adherence of the VieCovid app	To assess the user adherence of the VieCovid2020 smartphone application at 3 months	3 months
Impact of co-treatments	To assess the impact of co-treatments on superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from adjustments disorders or PTSD within the context of COVID-19, on the rate of responders on the PCL-5 at 3, 6 and 12 months .	3 months
Economic Impact	To assess the economic impact of using the VieCovid2020app	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2021
• Primary Completion (Estimated): June 15, 2023
• Study Completion (Estimated): June 15, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: APHP200426; 2021-A02141-40 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No