NCT01176929

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

3.1 years

First QC Date

August 5, 2010

Last Update Submit

April 10, 2013

Conditions

Keywords

Suicide, Attemptedprevention suicidal acttelephone contactprofessional coordination

Outcome Measures

Primary Outcomes (1)

  • suicidal act frequency

    The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.

    12 months

Secondary Outcomes (5)

  • suicide attempts frequency

    12 months

  • Adherence to health care

    12 months

  • Number of eligibles persons

    12 months

  • Number of participants responding to telephone calls

    12 months

  • Number of people lost sight of

    12 months

Study Arms (2)

Interventional group

EXPERIMENTAL

Usual treatment + prevention program of recurrent suicidal acts

Other: Usual treatment and Prevention program

Control group

ACTIVE COMPARATOR

Usual treatment

Other: Usual Treatment

Interventions

Prevention program of recurrent suicidal acts 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.

Also known as: Prevention program
Interventional group

Usual Treatment

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years.
  • Patients admitted to the emergency department for a suicide attempt.
  • Patients referred to outpatient care.
  • Patients who have given their written consent.

You may not qualify if:

  • Patients not affiliated to social security.
  • Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).
  • Patients hospitalized for longer than 72 hours.
  • Patients can not be recalled by phone (no phone, homeless, incarcerated)
  • Patients who do not speak French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris : BICETRE Hospital

Le Kremlin-Bicêtre, 94275, France

Location

Related Publications (1)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

MeSH Terms

Conditions

Suicide, Attempted

Interventions

National Program of Cancer Registries

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Centers for Disease Control and Prevention, U.S.United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and Organizations

Study Officials

  • Arnaud MARCHAND, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 6, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations