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

Completed

• Conditions: Stress Disorders, Post-Traumatic; Anxiety; Depression

• Registration Number: NCT01589575
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Study Start: 2012-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire	3 months after the patients is discharged from the ICU unit

Secondary Outcome Measures

Name	Time	Method
Number of interviews	During 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)
Edmonton Symptom Assessment Scale Score	4-6 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
* Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire	4-6 days after the admission of a patient to the ICU
VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU	During the ICU stay (days 1 to 28)	Visual Analog Scale ranging from 1 to 10

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France