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

NCT ID: NCT01589575

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Stress Disorders, Post-Traumatic Anxiety Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Roger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00501-42

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/CR-03

Identifier Type: -

Identifier Source: org_study_id

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