Patients Having Realized a Suicide AttemptPhase 3NCT02106949
Short Message System (SMS) Monitoring Intended for the Suicidal Patients
A Phase 3 study testing SMS contact with patient after discharge in intervention group in people with Patients Having Realized a Suicide Attempt, run by University Hospital, Brest at 13 sites in France.
Trial summary
The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Having Realized a Suicide Attempt
- What is being tested?
- SMS contact with patient after discharge in intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 13 sitesFrance
- Study dates
- 20 Aug 2014to 22 Mar 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Surviving a suicide attempt
- Leaving directly the emergency department or hospitalized less than 7 days
- Being able to be joined by telephone mobile
Who cannot join
- under guardianship
- Patient who are not able to provide a consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers
Angers
CHRU de Brest
Brest, 29609
CHU Caen
Caen
CHRU Lille
Lille
CHU de Lyon
Lyon
CHU Nantes
Nantes
CH Quimperlé
Quimperlé
CHU Rennes
Rennes
CHU de Saint-Etienne, Hôpital Nord
Saint-Etienne, 42055
CHU St Nazaire
Saint-Nazaire
CH St Malo
St-Malo, 35403
CHU Tours
Tours
CH Vannes
Vannes
About this study
Official title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.
- Being tested
- SMS contact with patient after discharge in intervention group
- Keywords
- suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare
- Medical subject headings
- Suicide, Attempted, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS contact with patient after discharge in intervention groupDevice
| Study group | Role | What they receive |
|---|---|---|
| SMS | Experimental | The patients of the test group receive a first SMS 48 hours after their discharge from the hospital then a total of 10 messages distributed over six months: 48 hours, S1, S2, M1, M2, M3, M4, M5, M6 and M13. Receives: Device: SMS contact with patient after discharge in intervention group |
| Without SMS | No intervention | The patients of the group benefit from the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of suicide reattempts in every group
Measured: 6 months
Secondary outcomes (6)
Number of suicide reattempts in every group
Measured: 13 months
Total number of suicidal second recurrences in every group
Measured: 6 months
Total number of suicidal second recurrences in every group
Measured: 13 months
Number of deaths by suicide
Measured: 6 months and 13 months
Score in the scale C-SSRS
Measured: inclusion, 6 months and 13 months
Presence of a disorder in the MINI: characterization of the comorbidity
Measured: 6 months and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start20 Aug 2014
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients Having Realized a Suicide AttemptStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Technopôle Brest-Iroise: LANESTEL SARL, 38 rue Jim Sevellec, 29200 Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106949
- Sponsor's protocol ID
- SIAM
- Other IDs
- RB 13-068 [CHRU Brest]
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2014
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
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 33884617Berrouiguet S, Larsen ME, Mesmeur C, Gravey M, Billot R, Walter M; HUGOPSY Network; Lemey C, Lenca P. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 10;6(1):e8. doi: 10.2196/mhealth.7780.
PubMed 29321126Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-Garcia E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.
PubMed 25404215
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
- ClinicalTrials.gov ID
- NCT02106949
- Acronym / sponsor ID
- SIAM
- Keywords
- suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Technopôle Brest-Iroise: LANESTEL SARL, 38 rue Jim Sevellec, 29200 Brest
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 8 Apr 2014 (estimated)
- 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.
The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS | Experimental | Device: SMS contact with patient after discharge in intervention groupThe patients of the test group receive a first SMS 48 hours after their discharge from the hospital then a total of 10 messages distributed over six months: 48 hours, S1, S2, M1, M2, M3, M4, M5, M6 and M13. |
| Without SMS | No intervention | –The patients of the group benefit from the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Surviving a suicide attempt
- Leaving directly the emergency department or hospitalized less than 7 days
- Being able to be joined by telephone mobile
Key exclusion criteria (2 listed)
- under guardianship
- Patient who are not able to provide a consent
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 |
|---|---|---|
| SMS contact with patient after discharge in intervention group | Device | SMS |
Primary outcome
Number of suicide reattempts in every group
Time frame: 6 months
6 secondary outcomes
Number of suicide reattempts in every group
Time frame: 13 months
Total number of suicidal second recurrences in every group
Time frame: 6 months
Total number of suicidal second recurrences in every group
Time frame: 13 months
Number of deaths by suicide
Time frame: 6 months and 13 months
Score in the scale C-SSRS
Time frame: inclusion, 6 months and 13 months
Presence of a disorder in the MINI: characterization of the comorbidity
Time frame: 6 months and 13 months
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 23 Jan 2025.
- 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.
- Derived from this study: PubMed 29321126Berrouiguet S, Larsen ME, Mesmeur C, Gravey M, Billot R, Walter M; HUGOPSY Network; Lemey C, Lenca P. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 10;6(1):e8. doi: 10.2196/mhealth.7780.
- Derived from this study: PubMed 25404215Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-Garcia E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMS contact with patient after discharge in intervention group in people with Patients Having Realized a Suicide Attempt, run by University Hospital, Brest at 13 sites in France.
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 4 inclusion and 2 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of suicide reattempts in every group (time frame: 6 months). 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 NCT02106949, which also lists 3 linked publications.
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 23 Jan 2025.