Psychological Trauma and Resilience After Critical Illness

Overview

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.

Full Title of Study: “Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 16, 2021

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

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with post-traumatic disorders
    • Time Frame: 3 months after ICU stay
    • IES-R scale

Secondary Measures

  • Proportion of resilient patients
    • Time Frame: 3 and 12 months after ICU stay
    • CD-RISC score > 80
  • proportion of patients with impaired Quality of life
    • Time Frame: 3 and 12 months after ICU stay
    • SF-36 score
  • Proportion of patients with post-traumatic disorders
    • Time Frame: 12 months after ICU stay
    • IES-R
  • Social support
    • Time Frame: 3 and 12 months after ICU stay
    • IES-R
  • perception of the disease
    • Time Frame: 3 and 12 months after ICU stay
    • MSPSS score

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean REIGNIER, PhD, Principal Investigator, Nantes University Hospital

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