Effect of Telephone Follow-up on Repeated Suicide Attempt in Patients (EXBRAYAT)

October 13, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

Effect of Telephone Follow-up on Repeated Suicide Attempt in Patients Discharged From an Emergency Psychiatry Department: a Controlled Study

Attempted suicide is a major public health problem, and the efficacies of current postvention protocols vary. The investigators evaluated the effectiveness of telephone follow-up of patients referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year.

In a single-center, controlled study with intent to treat, they evaluated the efficacy of a protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated for attempted suicide. For comparison, they evaluated as controls patients with similar social and demographic characteristics referred to their emergency psychiatric unit in the year prior to the study who did not receive telephone follow-up after their initial hospitalization. Data were analyzed using logistic regression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The importance of suicide and suicidal attempts recurrence is a major public health problem. Indeed, the suicide attempt is one of the most important predictors of suicide, as well as suicidal relapse is considered a suicide risk factor. It is therefore essential to establish the suicidal relapse prevention devices.

Moreover, the consensus conference on suicidal crisis (6) in particular stresses the importance of organizing continuity of care and foster a therapeutic alliance to avoid a break in continuity of care.

This study aims to evaluate the effectiveness of telephone Callback patients on suicide rate of recurrence at 6 months of suicidal gesture. A secondary objective is to assess and promote compliance.

Patients were included after a psychiatric interview following a suicide attempt in the North hospital's emergency unit no emergency hospitalization or indication in the interview before the release of the psychiatric emergency service. The interview provides an assessment of suicide risk and oral information about the protocol. A map showing the coordinates of the psychiatric emergency service and a reminder of the protocol is given. A consent form is signed. This protocol does not replace the usual care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
876

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • SAINt-ETIENNE, France, 42055
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Department of Emergency Psychiatry of CHU Saint-Etienne for suicide attempt

Description

Inclusion Criteria:

  • Patient affiliated or entitled to a social security scheme
  • Patient who have attempted suicide regardless of the medium
  • Patient falling 4 psychiatric sectors covered by the CHU of Saint-Etienne
  • Major and minor Patient (with parental permission)
  • Patient for which there is no evidence of psychiatric hospitalization sector or clinic immediately after switching to the suicidal act

Exclusion Criteria:

  • Homeless Patient
  • Patients for whom Callback is not possible (no phone, incarceration ...)
  • Patient who do not speak French
  • Patient admitted sector or clinic following the psychiatric interview inclusion
  • Patient Refusal
  • Medical Reason
  • Deleterious character of recontact by a doctor of the psychiatric emergency after passing the act

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients admitted of Psychiatry
Only patients who had a suicide attempt admitted to the Department of Emergency Psychiatry.
Behavioral: suicide attempt
suicide attempt : We evaluated the effectiveness of telephone follow-up of patients who had referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of suicidal recurrence rate
Time Frame: 6 months
Number of relapses of suicide attempts per patient over a period of 6 months.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the impact of the device on the number of deaths by suicide
Time Frame: 6 months
Number of deaths by suicide
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the impact on adherence to treatments
Time Frame: 6 months
The rate of adherence to treatments
6 months
Measuring the time between the TS and the first recurrence
Time Frame: 6 months
Time of recurrence compared to the suicide attempt
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupement Régional de Santé Publique

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Massoubre, PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1008071
  • 2010-A00804-35 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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