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

Depression Clinical Trial

— StressRéa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589575
• Other study ID #: LOCAL/2012/CR-03
• Secondary ID: 2012-A00501-42
• Status: Completed
• Phase: N/A
• First received: April 30, 2012
• Last updated: March 30, 2015
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Critical Illness
• Depression
• Depressive Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	* 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	No
Secondary	VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU	Visual Analog Scale ranging from 1 to 10	During the ICU stay (days 1 to 28)	No
Secondary	Number of interviews	Number of interviews the relative has with medical staff	During the ICU stay (days 1 to 28)	No
Secondary	Mean interview duration (minutes)		During the ICU stay (days 1 to 28)	No
Secondary	Edmonton Symptom Assessment Scale Score		4-6 days after the admission of a patient to the ICU	No
Secondary	The Impact of Event Scale - Revised (IES-R)		3 months after the patients is discharged from the ICU unit	No
Secondary	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)		3 months after the patients is discharged from the ICU unit	No