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

NCT ID: NCT04747405

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2022-12-22

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

Conditions

Intensive Care Unit Syndrome; Covid19; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A standard

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

B therapy group

standard of care and therapy group

Group Type: EXPERIMENTAL

therapy group

Intervention Type: OTHER

therapy group of maximum 8 people repeated twice

Interventions

therapy group

therapy group of maximum 8 people repeated twice

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain PERCOT

Role: STUDY_DIRECTOR

Cebtre Hospitalier Metropole Savoie

Locations

CH Métropole Savoie

Chambéry, , France

Countries

France

Other Identifiers

CHMS20009

Identifier Type: -

Identifier Source: org_study_id