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Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01589575
Acronym
StressRéa
Enrollment
208
Registered
2012-05-02
Start date
2012-09-30
Completion date
2015-01-31
Last updated
2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Stress Disorders, Post-Traumatic

Keywords

Intensive Care Unit

Brief summary

The main objective of this study is to compare the rate of reported anxiety / depression (HADS \>= 8) among spouses and other family members in ICU patients.

Detailed description

The secondary objectives of this study are: * to assess symptoms of anxiety (HADS ≥ 8) and depression (HADS ≥ 8) among relatives of ICU patients three months after discharge * to assess what relatives felt vis-à-vis the information process * describe the number and duration of interviews with participants * to compare variables between the groups spouses and other relatives. * satisfaction * number and duration of interviews * HADS questionnaire * The scale Edmunton * an internal questionnaire * IES-R score * level of mental well-being: WEMWBS * to describe the completeness of the study * to test the hypothesis that the development of symptoms related to physical manifestations of anxiety and depression predicts the development of post-traumatic stress at 3 months. * to assess the impact of the various forms of stress during hospitalization.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The relative must have given his/her informed and signed consent * The relative must be insured or beneficiary of a health insurance plan * The relative must be available for 3 months of follow-up

Exclusion criteria

* The relative is under judicial protection, under tutorship or curatorship * The relative refuses to sign the consent * It is impossible to correctly inform the relative

Design outcomes

Primary

MeasureTime frame
Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire3 months after the patients is discharged from the ICU unit

Secondary

MeasureTime frameDescription
VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICUDuring the ICU stay (days 1 to 28)Visual Analog Scale ranging from 1 to 10
Number of interviewsDuring the ICU stay (days 1 to 28)Number of interviews the relative has with medical staff
Mean interview duration (minutes)During the ICU stay (days 1 to 28)
* Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire4-6 days after the admission of a patient to the ICU
The Impact of Event Scale - Revised (IES-R)3 months after the patients is discharged from the ICU unit
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)3 months after the patients is discharged from the ICU unit
Edmonton Symptom Assessment Scale Score4-6 days after the admission of a patient to the ICU

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026