Clinical trial NCT01589575: Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
Official title: Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Anxiety
Depression
Keywords: Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes relatives of patients admitted to intensive care (over the age of 16 years and intubated and ventilated for at least 48 hours). The study population mainly inclused spouses, parents, children, and siblings of patients in intensive care.

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.

Eligibility 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

Primary outcomes:
measure: Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
timeFrame: 3 months after the patients is discharged from the ICU unit
Secondary outcomes:
measure: * Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
timeFrame: 4-6 days after the admission of a patient to the ICU
measure: VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU
timeFrame: During the ICU stay (days 1 to 28)
measure: Number of interviews
timeFrame: During the ICU stay (days 1 to 28)
measure: Mean interview duration (minutes)
timeFrame: During the ICU stay (days 1 to 28)
measure: Edmonton Symptom Assessment Scale Score
timeFrame: 4-6 days after the admission of a patient to the ICU
measure: The Impact of Event Scale - Revised (IES-R)
timeFrame: 3 months after the patients is discharged from the ICU unit
measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: 3 months after the patients is discharged from the ICU unit
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire Roger, MD
role: PRINCIPAL_INVESTIGATOR
References: