Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
|ClinicalTrials.gov Identifier: NCT01176929|
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : April 11, 2013
The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.
The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.
The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.
|Condition or disease||Intervention/treatment|
|Suicide, Attempted||Other: Usual treatment and Prevention program Other: Usual Treatment|
This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.
The program (experimental group) includes three interventions:
- A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
- A systematic telephone contact with the referring physician
- A telephone helpline for people who made a suicide attempt and referring physicians.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts|
|Study Start Date :||October 2009|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
Experimental: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
Other: Usual treatment and Prevention program
Prevention program of recurrent suicidal acts includes three interventions:
Other Name: Prevention program
Active Comparator: Control group
Other: Usual Treatment
- suicidal act frequency [ Time Frame: 12 months ]The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.
- suicide attempts frequency [ Time Frame: 12 months ]Number of occurrence of suicide attempts.
- Adherence to health care [ Time Frame: 12 months ]
Adherence to health care:
- The Initialization of outpatient care proposed by the suicidology's team at the initial interview or during telephone contacts.
- The number of consultations within 3 months after the first appointment with the referring doctor.
- Number of eligibles persons [ Time Frame: 12 months ]
Number of eligibles persons:
Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection.
- Number of participants responding to telephone calls [ Time Frame: 12 months ]
Number of participants responding to telephone calls:
We consider the failure to call after three unsuccessful telephone calls to three different days.
- Number of people lost sight of [ Time Frame: 12 months ]
Number of people lost sight of:
A person is considered lost sight if no information can be obtained after contact with the person himself, a third (nearest designated), a doctor (general practitioner and / or psychiatrist) and the nearest emergency department.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176929
|Assistance Publique - Hôpitaux de Paris : BICETRE Hospital|
|Le Kremlin Bicetre, France, 94275|
|Principal Investigator:||Arnaud MARCHAND, MD||Assistance Publique - Hôpitaux de Paris|