Suicide AttemptAPSOMNCT03427190
Suicide Prevention Algorithm in the French Overseas Territories
A study of Suicide Attempt, run by University Hospital Center of Martinique at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicide Attempt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 9 Oct 2017to 16 Oct 2020
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Reunion4 sites
Etablissement Psychiatrique de Santé Mentale
Saint-Benoît, 97470
Centre d'Accueil Psychiatrique Nord
Saint-Denis, 97405
Centre d'Accueil Psychiatrique Ouest-Centre
Saint-Paul, 97863
Centre d'Accueil d'Urgences Médico-Psychologique
Saint-Pierre, 97448
French Guiana2 sites
CH de Cayenne
Cayenne, 97306
CH Ouest Guyanais
Saint-Laurent-du-Maroni, 97393
Guadeloupe2 sites
CHU de Pointe à Pitre
Les Abymes, 97189
CH de Monteran
Saint-Claude, 97120
About this study
Official title: Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
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.
Read the detailed description
Since (1) Algos was never implemented in the French overseas departments (FOD) and does not involve primary care practitioners (PCP), (2) the additional effect of PCP involvement over and beyond Algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the FOD, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to Algos, of a healthcare professional, on the recurrence of suicide attempts in the FOD; the healthcare professional will be the patient's general practitioner, whenever possible.
- Conditions
- Suicide Attempt
- Being tested
- APSOM vs Control
- Keywords
- Suicide, Suicide attempted, Secondary Prevention, Relapse prevention, Case Management, Intervention Study
- 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.
APSOM vs ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: APSOM vs Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of a suicide
Reiteration of suicidal attempt after hospital discharge
Measured: 6 months
Existence of a suicide
Reiteration of suicidal attempt after hospital discharge
Measured: 13 months
Secondary outcomes (4)
Number of suicide attempts
To know total number of suicide
Measured: 6 and 13 months after hospital discharge
Number of deaths by suicide
To know number of deaths by suicide
Measured: 6 and 13 months after hospital discharge
Scores at the Hospital Anxiety and Depression Scale (HADS)
Pass the scale HADS
Measured: 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).
Pass the scale Columbia
Measured: 6 and 13 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start9 Oct 2017
- Primary completion8 Aug 2019
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Monteran, Guadeloupe, Centre Hospitalier Universitaire de la Guadeloupe, Centre Hospitalier de Cayenne, Centre Hospitalier de Ouest Guyanais Franck Joly, Centre d Accueil Psychiatrique Ouest-Centre, La Réunion, Centre d Accueil d Urgences Médico Psychologique, La Réunion, Centre d Accueil Psychiatrique Nord, La Réunion, Etablissement Publique de Santé Mentale de la Réunion
- Responsible party
- Sponsor
- Investigators
- JEHEL Louis, MD-PhD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427190
- Sponsor's protocol ID
- 15/B/04
- Acronym
- APSOM
- Status last verified
- Oct 2020
- First submitted
- 30 Jan 2017
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
- ClinicalTrials.gov ID
- NCT03427190
- Acronym / sponsor ID
- APSOM / 15/B/04
- Conditions
- Suicide Attempt
- Keywords
- Suicide, Suicide attempted, Secondary Prevention, Relapse prevention, Case Management, Intervention Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Monteran, Guadeloupe, Centre Hospitalier Universitaire de la Guadeloupe, Centre Hospitalier de Cayenne, Centre Hospitalier de Ouest Guyanais Franck Joly, Centre d Accueil Psychiatrique Ouest-Centre, La Réunion, Centre d Accueil d Urgences Médico Psychologique, La Réunion, Centre d Accueil Psychiatrique Nord, La Réunion, Etablissement Publique de Santé Mentale de la Réunion
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 9 Feb 2018 (actual)
- 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.
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.
Detailed description
Since (1) Algos was never implemented in the French overseas departments (FOD) and does not involve primary care practitioners (PCP), (2) the additional effect of PCP involvement over and beyond Algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the FOD, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to Algos, of a healthcare professional, on the recurrence of suicide attempts in the FOD; the healthcare professional will be the patient's general practitioner, whenever possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: APSOM vs ControlPhone 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. |
| APSOM | Other | Other: APSOM vs ControlIn 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APSOM vs ControlIn 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, Control |
Primary outcome
Existence of a suicide
Time frame: 6 months
Reiteration of suicidal attempt after hospital discharge
Existence of a suicide
Time frame: 13 months
Reiteration of suicidal attempt after hospital discharge
4 secondary outcomes
Number of suicide attempts
Time frame: 6 and 13 months after hospital discharge
Number of deaths by suicide
Time frame: 6 and 13 months after hospital discharge
Scores at the Hospital Anxiety and Depression Scale (HADS)
Time frame: 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).
Time frame: 6 and 13 months after hospital discharge
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 28 Jan 2021.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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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.
JEHEL Louis, MD-PhD principal investigator
CHU de Martinique
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Suicide Attempt, run by University Hospital Center of Martinique at 9 sites in 4 countries.
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 7 inclusion and 3 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Reunion, French Guiana, Guadeloupe, Martinique. 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?
Existence of a suicide (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427190, which also lists 1 linked publication.
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 28 Jan 2021.