Program to Promote Engagement in Care for the Prevention of Recidivism (PEPS)

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.

Study Overview

• Status: Unknown
• Conditions: Suicide; Case Management; Health Care Seeking Behavior
• Intervention / Treatment: Other: suicide attempt patient using PEPS Program

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: suicide attempt patient who will receive sanitory supervision; The control group will establish the health monitoring	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.; Other Names: Suicide attempt patient using sanitary supervision
Experimental: Suicide attempt patient who will participate to PEPS Program; The intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism.	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.; Other Names: Suicide attempt patient using sanitary supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Januel
• Investigators: Principal Investigator: Fayçal MOUAFFAK, Investigateur Principal

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 10477M-PEPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No