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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747405
• Other study ID #: CHMS20009
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Metropole Savoie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Covid19
• Depression
• Intensive Care Unit Syndrome

Intervention

Other:
• therapy group
therapy group of maximum 8 people repeated twice

Locations

Country	Name	City	State
France	CH Métropole Savoie	Chambéry

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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