Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study

Conditions
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Intensive Care Unit Syndrome, Covid19, Anxiety, Depression

Intervention / Treatment
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* Other: therapy group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: presenting psychological disease drug addiction participation to other interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A standard<br>standard of care | |
| Experimental: B therapy group<br>standard of care and therapy group | Other: therapy group<br>* therapy group of maximum 8 people repeated twice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months after intensive care hospitalization |