Depression Clinical Trial
— StressRéaOfficial title:
Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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