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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589575
First Posted: May 2, 2012
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition
Stress Disorders, Post-Traumatic Anxiety Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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 Measures:
  • * 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 ]
  • 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

  • Number of interviews [ Time Frame: During the ICU stay (days 1 to 28) ]
    Number of interviews the relative has with medical staff

  • Mean interview duration (minutes) [ Time Frame: During the ICU stay (days 1 to 28) ]
  • Edmonton Symptom Assessment Scale Score [ Time Frame: 4-6 days after the admission of a patient to the ICU ]
  • The Impact of Event Scale - Revised (IES-R) [ Time Frame: 3 months after the patients is discharged from the ICU unit ]
  • The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [ Time Frame: 3 months after the patients is discharged from the ICU unit ]

Enrollment: 208
Study Start Date: September 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spouses
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
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.

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589575


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Claire Roger, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01589575     History of Changes
Other Study ID Numbers: LOCAL/2012/CR-03
2012-A00501-42 ( Other Identifier: RCB number )
First Submitted: April 30, 2012
First Posted: May 2, 2012
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Intensive Care Unit

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Critical Illness
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders