Psychological Trauma and Resilience After Critical Illness

NCT ID: NCT05193123

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2021-12-16

Brief Summary

Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.

Detailed Description

Social demographic data (gender, age, marital status, psychological information and medical background) and medical data (severity of the disease, duration of ICU stay, SOFA score) will be collected, as for the NUTRIREA-3 trial.

Before leaving the ICU, patient who agreed to participate to the NUTRIREA 3 study were asked to participate to the RESIREA study.

Patients will be called by phone by a psychologist 3 months after their inclusion in the NUTRIREA-3 trial to complete the SF-36 score. Then, they will be asked to confirm their participation to the RESIREA study by completing four additional questionnaires (post-trauma stress disorder: IES-R; Resilience: CD-RISC; Social support: MSPSS; Perception of the disease: B-IPQ). If the patient does not respond to the phone call at the first time, he/she will be contacted again within a period of 2 weeks maximum (1 call/day). If the patient remains unreachable, he/she will be considered as lost for the study. Patients will be called again 12 months after their inclusion in the NUTRIREA-3 trial and will be asked to complete the five questionnaires (SF-36, IES-R, CD-RISC, MSPSS and B-IPQ).

During this last phone call, 40 patients will be asked to a third interview by phone. These patients will be spotted thanks to their score at the IES-R and CD-RISC. This interview of 30 to 45 minutes will be planned within 15 days after the T12 call and recorded. This semi structured interview will be lead by an experienced clinical psychologist and follow 4 main topics :

1. Experience of ICU's

2. Perception of the disease or/and post intensive care disorders

3. Difficulties and capacities of coping

4. Difficult events in the patient's life

Conditions

Acute Respiratory Failure; Shock

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Invasive mechanical ventilation started within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, for an expected duration of at least 48 hours after inclusion
• Treatment with vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
• Nutritional support expected to be started within 24 h after intubation
• Age older than 18 years
• Informed consent to participation in the study

Exclusion Criteria

• Invasive mechanical ventilation started more than 24 hours earlier
• Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition, or for chronic bowel disease
• Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
• Pregnancy, recent delivery, or lactation

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

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean REIGNIER, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU Amiens Picardie nord

Amiens, , France

CHU Amiens Picardie sud

Amiens, , France

CHU Angers

Angers, , France

CH Angoulême

Angoulême, , France

CH Annecy Genevois

Annecy, , France

CH Argenteuil

Argenteuil, , France

CHU Jean Minjoz

Besançon, , France

CH de Béthune

Béthune, , France

CH Chartres Louis Pasteur

Chartres, , France

CHU Gabriel Montpided

Clermont-Ferrand, , France

CH Dieppe

Dieppe, , France

APHP - Hôpital Raymond Poincaré

Garches, , France

CHD Vendée

La Roche-sur-Yon, , France

CH du Mans

Le Mans, , France

CH de Lens

Lens, , France

CHR- Roger Salengro

Lille, , France

Hôpital Edouard Herriot

Lyon, , France

CHU de Nantes

Nantes, , France

APHP - Hôpital Cochin

Paris, , France

CH de Bigorre

Tarbes, , France

CHRU Bretonneau

Tours, , France

CHU de Valenciennes

Valenciennes, , France

CHBA - Vannes Auray

Vannes, , France

Countries

France

Other Identifiers

MR_Resirea

Identifier Type: -

Identifier Source: org_study_id