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

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

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Key information

Conditions

Intensive Care Unit Syndrome Anxiety Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Depression Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Métropole Savoie

Chambéry, 73000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapy group

Other

therapy group of maximum 8 people repeated twice

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Acronym: GPR COVID

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 10, 2021
Registry last updated: Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed