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Completed

NCT Number: NCT01589575

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. * 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

  2. 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)

    Visual Analog Scale ranging from 1 to 10

  3. Number of interviews

    Time frame: During the ICU stay (days 1 to 28)

    Number of interviews the relative has with medical staff

  4. Mean interview duration (minutes)

    Time frame: During the ICU stay (days 1 to 28)

  5. Edmonton Symptom Assessment Scale Score

    Time frame: 4-6 days after the admission of a patient to the ICU

  6. The Impact of Event Scale - Revised (IES-R)

    Time frame: 3 months after the patients is discharged from the ICU unit

  7. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Time frame: 3 months after the patients is discharged from the ICU unit

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: StressRéa

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 2, 2012
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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