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NCT05054101 | Withdrawn

• 2 other identifiers: APHP2004262021-A02141-40
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• User adherence of the VieCovid app

  3 months

• Impact of co-treatments

  3 months

• Economic Impact

  6 months

Study Arms (2)

VieCovid2020 smartphone application

EXPERIMENTAL

The VieCovid2020 smartphone application in add-on to usual psychiatric intervention

Other: Real-time assessment using the VieCovid2020 smartphone application

Usual psychiatric intervention

PLACEBO COMPARATOR

Usual psychiatric intervention alone

Other: Real-time assessment using the VieCovid2020 smartphone application

Interventions

Real-time assessment using the VieCovid2020 smartphone application OTHER

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

Usual psychiatric intervention; VieCovid2020 smartphone application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: September 23, 2021
• Study Start: December 15, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08