SuicidePEPSNCT04366466
Program to Promote Engagement in Care for the Prevention of Recidivism
A study testing suicide attempt patient using PEPS Program in people with Suicide and Health Care Seeking Behavior, run by Januel.
Trial summary
In France, the number of emergency visits for suicide attempts is estimated at 220,000 per year. Suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Health Care Seeking Behavior, Case Management
- What is being tested?
- suicide attempt patient using PEPS Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18.
- Male and female.
- Admission to CH St Denis for a suicide attempt.
- Referral for outpatient follow-up.
- Patient with no psychiatric follow-up or who has been out of follow-up for at least three months.
- Patient having given their written informed consent.
Who cannot join
- Patients not affiliated with social security or state medical aid.
- Patients who do not have the required faculties to be evaluated (cognitive and delusional disorders).
- Patients treated for more than 72 hours after their procedure (maximum length of stay in the UAS and/or in medical intensive care.
- Patient currently under psychiatric care.
- Patients who cannot be called back by telephone (no telephone, homeless, incarceration).
- Patients who do not master the French language.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Program to Promote Commitment to Care for the Prevention of Suicidal Recurrence (Health Monitoring and Case Management) Versus Usual Treatment (Health Monitoring): Randomized Controlled Interventional Study in Routine Care.
In France, the number of emergency visits for suicide attempts is estimated at 220,000 per year. Suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences.
To day, no study has compared the approaches to health surveillance and case management in a clinical trial, nor established the benefit of each on commitment to care and beyond the prevention of suicidal recurrence.
- Conditions
- Suicide, Health Care Seeking Behavior, Case Management
- Being tested
- suicide attempt patient using PEPS Program
- Medical subject headings
- Suicide, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suicide attempt patient using PEPS ProgramOther
Also called Suicide attempt patient using sanitary supervision
The research protocol consists of two phases separated by randomization.
A Hospital Phase common to both groups:
Day zero is the day of the suicide attempt for which the patient came to the hospital.
A post-hospital phase including the P.E.P.S. program for the intervention group and telephone reminders for the usual treatment group.
| Study group | Role | What they receive |
|---|---|---|
| suicide attempt patient who will receive sanitory supervision | Other | The control group will establish the health monitoring Receives: Other: suicide attempt patient using PEPS Program |
| Suicide attempt patient who will participate to PEPS Program | Experimental | The intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism. Receives: Other: suicide attempt patient using PEPS Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI)
rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
Measured: Day 0
Suicide Intent Scale
The Suicide Intent Scale (SIS) developed by A.T. BECK in 1974, is the only scale that focuses solely on the assessment of the suicide attempt that has just taken place.
Measured: Day 0
Montgomery-Asberg depression rating scale
This scale is widely used to measure the changes brought about by the treatment of depression. It assesses the severity of symptoms in a wide variety of areas such as mood, sleep and appetite, physical and mental fatigue, and thoughts of suicide.
Measured: Day 0
Secondary outcomes (3)
Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism
percentage of all suicidants who relapse during the 12-month study period.
Measured: 1 year
Evaluate the level of possible generalization of the program
percentage of all suicides of subjects likely to benefit from the program (subjects fulfilling the inclusion and non-inclusion criteria).
Measured: 1 year
Evaluate the feasibility of the program
percentage of subjects included in the intervention group who received all interventions); weighted by the percentage of acceptance to participate in the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
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 SuicideStudies 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
- Model description
- Controlled, randomized and prospective study of a cohort of suicide victims comparing an experimental (interventional) group to a control group (usual treatment)
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Januel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Fayçal MOUAFFAK, Principal investigator, Investigateur Principal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366466
- Sponsor's protocol ID
- 10477M-PEPS
- Acronym
- PEPS
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program to Promote Commitment to Care for the Prevention of Suicidal Recurrence (Health Monitoring and Case Management) Versus Usual Treatment (Health Monitoring): Randomized Controlled Interventional Study in Routine Care.
- ClinicalTrials.gov ID
- NCT04366466
- Acronym / sponsor ID
- PEPS / 10477M-PEPS
- Conditions
- Suicide, Health Care Seeking Behavior, Case Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- JanuelUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 29 Apr 2020 (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, the number of emergency visits for suicide attempts is estimated at 220,000 per year. Suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences.
To day, no study has compared the approaches to health surveillance and case management in a clinical trial, nor established the benefit of each on commitment to care and beyond the prevention of suicidal recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled, randomized and prospective study of a cohort of suicide victims comparing an experimental (interventional) group to a control group (usual treatment)
| Arm | Type | Receives |
|---|---|---|
| suicide attempt patient who will receive sanitory supervision | Other | Other: suicide attempt patient using PEPS ProgramThe control group will establish the health monitoring |
| Suicide attempt patient who will participate to PEPS Program | Experimental | Other: suicide attempt patient using PEPS ProgramThe intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18.
- Male and female.
- Admission to CH St Denis for a suicide attempt.
- Referral for outpatient follow-up.
- Patient with no psychiatric follow-up or who has been out of follow-up for at least three months.
Key exclusion criteria (6 listed)
- Patients not affiliated with social security or state medical aid.
- Patients who do not have the required faculties to be evaluated (cognitive and delusional disorders).
- Patients treated for more than 72 hours after their procedure (maximum length of stay in the UAS and/or in medical intensive care.
- Patient currently under psychiatric care.
- Patients who cannot be called back by telephone (no telephone, homeless, incarceration).
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 |
|---|---|---|
| suicide attempt patient using PEPS ProgramAlso: Suicide attempt patient using sanitary supervisionThe research protocol consists of two phases separated by randomization. A Hospital Phase common to both groups: Day zero is the day of the suicide attempt for which the patient came to the hospital. A post-hospital phase including the P.E.P.S. program for the intervention group and telephone reminders for the usual treatment group. | Other | Suicide attempt patient who will participate to PEPS Program, suicide attempt patient who will receive sanitory supervision |
Primary outcome
Clinical Global Impression (CGI)
Time frame: Day 0
rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
Suicide Intent Scale
Time frame: Day 0
The Suicide Intent Scale (SIS) developed by A.T. BECK in 1974, is the only scale that focuses solely on the assessment of the suicide attempt that has just taken place.
Montgomery-Asberg depression rating scale
Time frame: Day 0
This scale is widely used to measure the changes brought about by the treatment of depression. It assesses the severity of symptoms in a wide variety of areas such as mood, sleep and appetite, physical and mental fatigue, and thoughts of suicide.
3 secondary outcomes
Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism
Time frame: 1 year
Evaluate the level of possible generalization of the program
Time frame: 1 year
Evaluate the feasibility of the program
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- 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.
Fayçal MOUAFFAK principal investigator
Investigateur Principal
Questions about this trial
What is this clinical trial studying?
A study testing suicide attempt patient using PEPS Program in people with Suicide and Health Care Seeking Behavior, run by Januel.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youcef BENCHERIF (01.43.09.32.32, y.bencherif@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression (CGI) (time frame: Day 0). The study lists 3 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 NCT04366466, 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 30 Apr 2020.