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

Centre Hospitalier Metropole Savoie

Status: Completed

Conditions: Covid19; Depression; Anxiety; Intensive Care Unit Syndrome

Treatments: Other: therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT04747405

CHMS20009

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

A standard

No Intervention group

Description:

standard of care

B therapy group

Experimental group

Description:

standard of care and therapy group

Treatment:

Other: therapy group