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

Not Applicable

Completed

• Conditions: Anxiety; Intensive Care Unit Syndrome; Depression; Covid19
• Interventions: Other: therapy group

• Registration Number: NCT04747405
• Lead Sponsor: Centre Hospitalier Metropole Savoie

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Study Start: 2021-02-22
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B therapy group	therapy group	standard of care and therapy group

Primary Outcome Measures

Name	Time	Method
prevalence of post traumatic stress syndrome	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

Trial Locations

Locations (1)

CH Métropole Savoie; 🇫🇷 Chambéry, France