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

Sponsor
Januel (Other)
Overall Status
Unknown status
CT.gov ID
NCT04366466
Collaborator
(none)
138
2
16

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: suicide attempt patient using PEPS Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Controlled, randomized and prospective study of a cohort of suicide victims comparing an experimental (interventional) group to a control group (usual treatment)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)
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical Global Impression (CGI) [Day 0]

      rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.

    2. Suicide Intent Scale [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.

    3. Montgomery-Asberg depression rating scale [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.

    Secondary Outcome Measures

    1. Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism [1 year]

      percentage of all suicidants who relapse during the 12-month study period.

    2. Evaluate the level of possible generalization of the program [1 year]

      percentage of all suicides of subjects likely to benefit from the program (subjects fulfilling the inclusion and non-inclusion criteria).

    3. Evaluate the feasibility of the program [1 year]

      percentage of subjects included in the intervention group who received all interventions); weighted by the percentage of acceptance to participate in the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Januel

    Investigators

    • Principal Investigator: Fayçal MOUAFFAK, Investigateur Principal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Januel, Head of clinical research unit, Centre hospitalier de Ville-Evrard, France
    ClinicalTrials.gov Identifier:
    NCT04366466
    Other Study ID Numbers:
    • 10477M-PEPS
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Apr 30, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 30, 2020