Stress Disorders, Post-TraumaticStressRéaNCT01589575
Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
An observational study of Stress Disorders, Post-Traumatic and Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Symptoms of 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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Keywords
- Intensive Care Unit
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
Measured: 3 months after the patients is discharged from the ICU unit
Secondary outcomes (7)
* Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire
Measured: 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
Visual Analog Scale ranging from 1 to 10
Measured: During the ICU stay (days 1 to 28)
Number of interviews
Number of interviews the relative has with medical staff
Measured: During the ICU stay (days 1 to 28)
Mean interview duration (minutes)
Measured: During the ICU stay (days 1 to 28)
Edmonton Symptom Assessment Scale Score
Measured: 4-6 days after the admission of a patient to the ICU
The Impact of Event Scale - Revised (IES-R)
Measured: 3 months after the patients is discharged from the ICU unit
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Measured: 3 months after the patients is discharged from the ICU unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589575
- Sponsor's protocol ID
- LOCAL/2012/CR-03
- Other IDs
- 2012-A00501-42
- Acronym
- StressRéa
- Status last verified
- Mar 2015
- First submitted
- 30 Apr 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
- ClinicalTrials.gov ID
- NCT01589575
- Acronym / sponsor ID
- StressRéa / LOCAL/2012/CR-03
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Keywords
- Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
* 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)
Number of interviews
Time frame: During the ICU stay (days 1 to 28)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Roger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.