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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT01589575
• Date of registration: 30/04/2012
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives StressRéa
• Scientific title: Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
• Date of first enrolment: September 2012
• Target sample size: 208
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01589575
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Claire Roger, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stress Disorders, Post-Traumatic

Depression

Anxiety

Primary Outcome(s)

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

Secondary Outcome(s)

The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [Time Frame: 3 months after the patients is discharged from the ICU unit]

Mean interview duration (minutes) [Time Frame: During the ICU stay (days 1 to 28)]

The Impact of Event Scale - Revised (IES-R) [Time Frame: 3 months after the patients is discharged from the ICU unit]

Edmonton Symptom Assessment Scale Score [Time Frame: 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 [Time Frame: During the ICU stay (days 1 to 28)]

* Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire [Time Frame: 4-6 days after the admission of a patient to the ICU]

Number of interviews [Time Frame: During the ICU stay (days 1 to 28)]

Secondary ID(s)

2012-A00501-42

LOCAL/2012/CR-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors