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

This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01589575
First received: April 30, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    Visual Analog Scale ranging from 1 to 10

  • Number of interviews [ Time Frame: During the ICU stay (days 1 to 28) ] [ Designated as safety issue: No ]
    Number of interviews the relative has with medical staff

  • Mean interview duration (minutes) [ Time Frame: During the ICU stay (days 1 to 28) ] [ Designated as safety issue: No ]
  • Edmonton Symptom Assessment Scale Score [ Time Frame: 4-6 days after the admission of a patient to the ICU ] [ Designated as safety issue: No ]
  • The Impact of Event Scale - Revised (IES-R) [ Time Frame: 3 months after the patients is discharged from the ICU unit ] [ Designated as safety issue: No ]
  • The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [ Time Frame: 3 months after the patients is discharged from the ICU unit ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589575

Contacts
Contact: Claire Roger, MD +33.(0)4.66.68.30.50 clairepenetrat@hotmail.com
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Sub-Investigator: Guillaume Louart, MD            
Principal Investigator: Claire Roger, MD            
Sub-Investigator: Justine Pereira            
Sub-Investigator: Jean Yves Lefrant, MD PhD            
Sub-Investigator: Fabienne Cyprien, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Claire Roger, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

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
Study First Received: April 30, 2012
Last Updated: March 26, 2013
Health Authority: France: Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on May 22, 2013