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Clinical Trials/NCT04747405
NCT04747405
Completed
Not Applicable

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

Centre Hospitalier Metropole Savoie1 site in 1 country59 target enrollmentFebruary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit Syndrome
Sponsor
Centre Hospitalier Metropole Savoie
Enrollment
59
Locations
1
Primary Endpoint
prevalence of post traumatic stress syndrome
Status
Completed
Last Updated
2 years ago

Overview

Brief 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 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
Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
December 22, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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