Intensive Care Unit SyndromeGPR COVIDNCT04747405
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
A study testing therapy group in people with Intensive Care Unit Syndrome and Covid19, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Covid19, Anxiety
- What is being tested?
- therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2021to 22 Dec 2022
- 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
- 18 years old and older
- hospitalized at least 72h in intensive care during COVID-19 pandemic crisis
- out of intensive care for at least 2 months and maximum 6 months
- psychological evaluation done according to local practice and standard of care
- speaking french
- patient coming alone to the therapy group
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- patient agree to respect confidentiality rules and demonstrating goodwill with others participants
- patient comite to respecting barriers rules against COVID-19
- affiliated to social security system
- no juridic protection engaged
Who cannot join
- presenting psychological disease
- drug addiction
- participation to other interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.
For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.
Read more
The investigators will compare two groups:
- group receiving standard of care
- group receiving standard of care and therapy group
- Conditions
- Intensive Care Unit Syndrome, Covid19, Anxiety, Depression
- Being tested
- therapy group
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapy groupOther
therapy group of maximum 8 people repeated twice
| Study group | Role | What they receive |
|---|---|---|
| A standard | No intervention | standard of care |
| B therapy group | Experimental | standard of care and therapy group Receives: Other: therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of post traumatic stress syndrome
the aim is to compare the prevalence of post traumatic stress syndrome between both groups 12 months after exiting intensive care unit
Measured: 12 months after intensive care hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start22 Feb 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain PERCOT, Study director, Cebtre Hospitalier Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747405
- Sponsor's protocol ID
- CHMS20009
- Acronym
- GPR COVID
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
- ClinicalTrials.gov ID
- NCT04747405
- Acronym / sponsor ID
- GPR COVID / CHMS20009
- Conditions
- Intensive Care Unit Syndrome, Covid19, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 10 Feb 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.
Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.
For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.
The investigators will compare two groups:
- group receiving standard of care
- group receiving standard of care and therapy group
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A standard | No intervention | –standard of care |
| B therapy group | Experimental | Other: therapy groupstandard of care and therapy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old and older
- hospitalized at least 72h in intensive care during COVID-19 pandemic crisis
- out of intensive care for at least 2 months and maximum 6 months
- psychological evaluation done according to local practice and standard of care
- speaking french
Key exclusion criteria (3 listed)
- presenting psychological disease
- drug addiction
- participation to other interventional clinical trial
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 |
|---|---|---|
| therapy grouptherapy group of maximum 8 people repeated twice | Other | B therapy group |
Primary outcome
prevalence of post traumatic stress syndrome
Time frame: 12 months after intensive care hospitalization
the aim is to compare the prevalence of post traumatic stress syndrome between both groups 12 months after exiting intensive care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Romain PERCOT study director
Cebtre Hospitalier Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapy group in people with Intensive Care Unit Syndrome and Covid19, run by Centre Hospitalier Metropole Savoie at 1 site in France.
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 10 inclusion and 3 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: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of post traumatic stress syndrome (time frame: 12 months after intensive care hospitalization). 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 30 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.