PTSDVieCovid2020NCT05054101
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
A study testing Real-time assessment using the VieCovid2020 smartphone application in people with PTSD, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Real-time assessment using the VieCovid2020 smartphone application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 15 Jun 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
About this study
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.
Read more
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.
Read the 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.
- Conditions
- PTSD
- Being tested
- Real-time assessment using the VieCovid2020 smartphone application
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time assessment using the VieCovid2020 smartphone applicationOther
a real-time assessment using the VieCovid2020 smartphone application during the first 3 months in add-on to usual psychiatric intervention
| Study group | Role | What they receive |
|---|---|---|
| VieCovid2020 smartphone application | Experimental | The VieCovid2020 smartphone application in add-on to usual psychiatric intervention Receives: Other: Real-time assessment using the VieCovid2020 smartphone application |
| Usual psychiatric intervention | Placebo comparator | Usual psychiatric intervention alone Receives: Other: Real-time assessment using the VieCovid2020 smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 MONTHS
Secondary outcomes (3)
User adherence of the VieCovid app
To assess the user adherence of the VieCovid2020 smartphone application at 3 months
Measured: 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 .
Measured: 3 months
Economic Impact
To assess the economic impact of using the VieCovid2020app
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Why it stopped: Unresolved issues between research partners (research has not started)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054101
- Sponsor's protocol ID
- APHP200426
- Other IDs
- 2021-A02141-40
- Acronym
- VieCovid2020
- Status last verified
- Aug 2024
- First submitted
- 22 Sep 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05054101
- Acronym / sponsor ID
- VieCovid2020 / APHP200426
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unresolved issues between research partners (research has not started)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VieCovid2020 smartphone application | Experimental | Other: Real-time assessment using the VieCovid2020 smartphone applicationThe VieCovid2020 smartphone application in add-on to usual psychiatric intervention |
| Usual psychiatric intervention | Placebo comparator | Other: Real-time assessment using the VieCovid2020 smartphone applicationUsual psychiatric intervention alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time assessment using the VieCovid2020 smartphone applicationa real-time assessment using the VieCovid2020 smartphone application during the first 3 months in add-on to usual psychiatric intervention | Other | Usual psychiatric intervention, VieCovid2020 smartphone application |
Primary outcome
Superiority of the VieCovid2020 smartphone app
Time frame: 6 MONTHS
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.
3 secondary outcomes
User adherence of the VieCovid app
Time frame: 3 months
Impact of co-treatments
Time frame: 3 months
Economic Impact
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time assessment using the VieCovid2020 smartphone application in people with PTSD, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Superiority of the VieCovid2020 smartphone app (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.