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

NCT04747405 | Completed

• 1 other identifier: CHMS20009
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A standard

NO INTERVENTION

standard of care

B therapy group

EXPERIMENTAL

standard of care and therapy group

Other: therapy group

Interventions

therapy group OTHER

therapy group of maximum 8 people repeated twice

B therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presenting psychological disease
• drug addiction
• participation to other interventional clinical trial

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

CH Métropole Savoie

Chambéry, 73000, France

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Depression

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Romain PERCOT

  Cebtre Hospitalier Metropole Savoie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 10, 2021
• Study Start: February 22, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)