Back to resultsEvaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study (GPR COVID)
Primary Purpose
Intensive Care Unit Syndrome, Covid19, Anxiety
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapy group
Sponsored by
About this trial
This is an interventional other trial for Intensive Care Unit Syndrome
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
Sites / Locations
- CH Métropole Savoie
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
A standard
B therapy group
Arm Description
standard of care
standard of care and therapy group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04747405
First Posted
February 9, 2021
Last Updated
August 29, 2023
Sponsor
Centre Hospitalier Metropole Savoie
1. Study Identification
Unique Protocol Identification Number
NCT04747405
Brief Title
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
Acronym
GPR COVID
Official Title
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Syndrome, Covid19, Anxiety, Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A standard
Arm Type
No Intervention
Arm Description
standard of care
Arm Title
B therapy group
Arm Type
Experimental
Arm Description
standard of care and therapy group
Intervention Type
Other
Intervention Name(s)
therapy group
Intervention Description
therapy group of maximum 8 people repeated twice
Primary Outcome Measure Information:
Title
prevalence of post traumatic stress syndrome
Description
the aim is to compare the prevalence of post traumatic stress syndrome between both groups 12 months after exiting intensive care unit
Time Frame
12 months after intensive care hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain PERCOT
Organizational Affiliation
Cebtre Hospitalier Metropole Savoie
Official's Role
Study Director
Facility Information:
Facility Name
CH Métropole Savoie
City
Chambéry
ZIP/Postal Code
73000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
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