Program to Promote Engagement in Care for the Prevention of Recidivism

Suicide Clinical Trial

— PEPS  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04366466
• Other study ID #: 10477M-PEPS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: September 2021

Study information

• Verified date: April 2020
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Youcef BENCHERIF
• Phone: 01.43.09.32.32
• Email: y.bencherif[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Case Management
• Health Care Seeking Behavior
• Suicide

Intervention

Other:
• suicide attempt patient using PEPS Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Januel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	Day 0
Primary	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.	Day 0
Secondary	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.	1 year
Secondary	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).	1 year
Secondary	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	1 year