Suicide, AttemptedIMTAPNCT01213797
IMTAP : Impact of the Suicide Attempt on the Nearly Entourage in Term of Traumatic Stress and Medico-economic Impact
An observational study of Suicide, Attempted and Relatives, run by University Hospital, Lille at 12 sites in France.
Trial summary
With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an important public health problem. For each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (Terra 2001). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Relatives
- How many people
- 372 participants
- Where
- 12 sitesFrance
- Study dates
- Mar 2006to Sep 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 500 families; 500 committing suicide and approximately 900 close relatives.
Who may be able to join
- Men or women
- Older than 18 years
- Survivor with an suicide attempt going back to less than 15 days
- Inclusion Criteria for close relations of committing suicide :
- Men or women
- age more than 18 years
- Members of the entourage of committing suicide
- Living under the same roof as committing suicide it
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
University Hospital, Angers
Angers
University Hospital, Brest
Brest
University Hospital, Caen
Caen
University Hospital, Clermont-Ferrand
Clermont-Ferrand
University Hospital, Lille
Lille
University Hospital, Limoges
Limoges
Le Vinatier Hospital
Lyon
University Hospital, Nancy
Nancy
University Hospital, Nice
Nice
Tenon Hospital, Paris
Paris
General Hospital, Quimper
Quimper
EPSM Lille Metropole
Tourcoing
About this study
Official title: Impact of the Suicide Attempt on the Close Entourage: Traumatic Stress and Medico-economic Concerns, in Medium and Long Term
With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an important public health problem. For each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (Terra 2001). In term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide and 3.750.000 people (annually) touched by the "suicide attempt" of a close relative. It seems indeed important to have Public Health data on this cascade repercussion of the suicide attempt.
A suicide attempt propagates a suffering cascade on the various circles of the family and close entourage, which can be measured in term of traumatic stress and medico-economic impact.
Objective = To measure the medico-economic impact on the entourage, in the 3 months following the suicide attempt and at 1 year.
Read the detailed description
Secondary objectives = To measure the impact of the suicide attempt in traumatic term of stress on the close relatives of committing suicide confronted with the suicidal scene To compare the evolution of consumption of care of the close relatives and of committing suicide To measure the evolution of the general health condition of the close relatives and of committing suicide
The study participants (committing suicide it and the relatives) will be recontacted by telephone, after 3 months and to 1 year.
Consumption of care (number of consultations, drugs consumption) of the population of the close relatives of committing suicide will be compared with the data of the Research Institute and Documentation in Economy of Health (IRDES) on the French population (sample of 20.000 people, representative of 95% of the French households).
- Conditions
- Suicide, Attempted, Relatives
- Keywords
- Suicide
- Medical subject headings
- Suicide, Attempted, Suicide
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 |
|---|---|---|
| Suicide attempter and its entourage | Suicide attempter and its close relatives (who are living under the same roof) Comparison of the population of the close relations of committing suicide with the data of the Research Institute and Documentation in Economy of Health (IRDES) on the French population (sample of 20.000 people, representative of 95% of the French households). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of care in the close relatives of a suicide attempter
Consumption of care in the close relatives of a suicide attempter, at the various stages of evaluation, compared with a matched sample in general population (data IRDES). One will be able to thus evaluate not only if the consumption of the close relatives is higher than the average, but still if this difference increases or on the contrary decreases during time.
Measured: one year
Secondary outcomes (4)
Psychological level of distress
Psychological level of distress in the close relatives
Measured: one year
Links between consumption of care and psychological level of distress
Links between consumption of care and psychological level of distress
Measured: one year
Prevalence of the post-traumatic stress disorder
Post-traumatic stress disorder at 3 months and one year, as evaluated by the PTSD Check List Symptoms among members of the entourage having been exposed to the scene of the suicide attempt.
Comparison of prevalence of the post-traumatic disorder of stress compared to the index of lethality of the suicide attempt index.
Measured: one year
Evolution of consumption of care
Evolution of consumption of care at committing suicide compared to the remainder of the household and the general population
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startMar 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume VAIVA, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213797
- Sponsor's protocol ID
- DGS 2006/0116
- Other IDs
- PHRC 2005/1917, 2006/0603
- Acronym
- IMTAP
- Status last verified
- Jul 2011
- First submitted
- 1 Oct 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Suicide Attempt on the Close Entourage: Traumatic Stress and Medico-economic Concerns, in Medium and Long Term
- ClinicalTrials.gov ID
- NCT01213797
- Acronym / sponsor ID
- IMTAP / DGS 2006/0116
- Conditions
- Suicide, Attempted, Relatives
- Keywords
- Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Oct 2010 (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.
With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an important public health problem. For each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (Terra 2001). In term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide and 3.750.000 people (annually) touched by the "suicide attempt" of a close relative. It seems indeed important to have Public Health data on this cascade repercussion of the suicide attempt.
A suicide attempt propagates a suffering cascade on the various circles of the family and close entourage, which can be measured in term of traumatic stress and medico-economic impact.
Objective = To measure the medico-economic impact on the entourage, in the 3 months following the suicide attempt and at 1 year.
Detailed description
Secondary objectives = To measure the impact of the suicide attempt in traumatic term of stress on the close relatives of committing suicide confronted with the suicidal scene To compare the evolution of consumption of care of the close relatives and of committing suicide To measure the evolution of the general health condition of the close relatives and of committing suicide
The study participants (committing suicide it and the relatives) will be recontacted by telephone, after 3 months and to 1 year.
Consumption of care (number of consultations, drugs consumption) of the population of the close relatives of committing suicide will be compared with the data of the Research Institute and Documentation in Economy of Health (IRDES) on the French population (sample of 20.000 people, representative of 95% of the French households).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicide attempter and its entourage | – | –Suicide attempter and its close relatives (who are living under the same roof) Comparison of the population of the close relations of committing suicide with the data of the Research Institute and Documentation in Economy of Health (IRDES) on the French population (sample of 20.000 people, representative of 95% of the French households). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 500 families; 500 committing suicide and approximately 900 close relatives.
Key inclusion criteria (8 listed)
- Men or women
- Older than 18 years
- Survivor with an suicide attempt going back to less than 15 days
- Men or women
- age more than 18 years
Key exclusion criteria (0 listed)
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
Consumption of care in the close relatives of a suicide attempter
Time frame: one year
Consumption of care in the close relatives of a suicide attempter, at the various stages of evaluation, compared with a matched sample in general population (data IRDES). One will be able to thus evaluate not only if the consumption of the close relatives is higher than the average, but still if this difference increases or on the contrary decreases during time.
4 secondary outcomes
Psychological level of distress
Time frame: one year
Links between consumption of care and psychological level of distress
Time frame: one year
Prevalence of the post-traumatic stress disorder
Time frame: one year
Evolution of consumption of care
Time frame: one year
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 25 Oct 2011.
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Suicide
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.
Guillaume VAIVA principal investigator
University Hospital, Lille
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted and Relatives, run by University Hospital, Lille at 12 sites 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 8 inclusion and 0 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 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Consumption of care in the close relatives of a suicide attempter (time frame: one year). 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 25 Oct 2011.