NCT03427190

Brief Summary

In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
259

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
4 countries

9 active sites

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

First Submitted

Initial submission to the registry

January 30, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

January 28, 2021

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

January 30, 2017

Last Update Submit

January 26, 2021

Conditions

Keywords

SuicideSuicide attemptedSecondary PreventionRelapse preventionCase ManagementIntervention Study

Outcome Measures

Primary Outcomes (2)

  • Existence of a suicide

    Reiteration of suicidal attempt after hospital discharge

    6 months

  • Existence of a suicide

    Reiteration of suicidal attempt after hospital discharge

    13 months

Secondary Outcomes (4)

  • Number of suicide attempts

    6 and 13 months after hospital discharge

  • Number of deaths by suicide

    6 and 13 months after hospital discharge

  • Scores at the Hospital Anxiety and Depression Scale (HADS)

    6 and 13 months after hospital discharge

  • Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS).

    6 and 13 months after hospital discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

Phone contact with patient will be made by a professional psychologist within 21 days of hospital discharge. If contact cannot be made after 9 attempts, post-cards will be sent monthly at M2, M3, M4 and M5, asking the participant to establish contact with the designated psychologist. The phone call will determine whether or not the participant is in a state of suicidal crisis. If yes, steps will be taken to attend the crisis within 24 hours.

Other: APSOM vs Control

APSOM

OTHER

In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.

Other: APSOM vs Control

Interventions

In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.

APSOMControl

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman over 16 years of age
  • Leaving the hospital within 15 days of the suicide attempt
  • Giving (him/herself or his/her legal representative)an oral consent to participate in the study
  • Having healthcare insurance
  • Reachable by phone, with possibility of confidential conversation, and by mail
  • Resident of Guadeloupe, French Guyana, Martinique, or Reunion Island
  • Able to understand and speak French

You may not qualify if:

  • Homeless person
  • Disabled adult, person under judicial/court protection, legally incompetent adult
  • Participant unable to understand the study protocol, its risks and side effects, or declining to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CH de Cayenne

Cayenne, 97306, French Guiana

Location

CH Ouest Guyanais

Saint-Laurent-du-Maroni, 97393, French Guiana

Location

CHU de Pointe à Pitre

Les Abymes, 97189, Guadeloupe

Location

CH de Monteran

Saint-Claude, 97120, Guadeloupe

Location

CHU Martinique

Fort-de-France, 97261, Martinique

Location

Etablissement Psychiatrique de Santé Mentale

Saint-Benoît, 97470, Reunion

Location

Centre d'Accueil Psychiatrique Nord

Saint-Denis, 97405, Reunion

Location

Centre d'Accueil Psychiatrique Ouest-Centre

Saint-Paul, 97863, Reunion

Location

Centre d'Accueil d'Urgences Médico-Psychologique

Saint-Pierre, 97448, Reunion

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, AttemptedSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • JEHEL Louis, MD-PhD

    CHU de Martinique

    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

January 30, 2017

First Posted

February 9, 2018

Study Start

October 9, 2017

Primary Completion

August 8, 2019

Study Completion

October 16, 2020

Last Updated

January 28, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations