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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Stress Disorders, Post-Traumatic
Depression
Anxiety

Study type

Observational

Funder types

Other

Identifiers

NCT01589575
LOCAL/2012/CR-03
2012-A00501-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

208 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

208 participants in 2 patient groups

Spouses
Description:
This group of relatives includes the spouses of ICU patients (over 16 years of age and intubated and under ventilation for at least 48 hours) meeting stated inclusion criteria.
Other relatives
Description:
This group of relatives includes the non-spouse relatives of ICU patients (over 16 years of age and intubated and under ventilation for at least 48 hours) meeting stated inclusion criteria.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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