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

Primary Purpose

Suicide, Health Care Seeking Behavior, Case Management

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
suicide attempt patient using PEPS Program
Sponsored by
Januel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    suicide attempt patient who will receive sanitory supervision

    Suicide attempt patient who will participate to PEPS Program

    Arm Description

    The control group will establish the health monitoring

    The intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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).
    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

    Full Information

    First Posted
    April 16, 2020
    Last Updated
    April 29, 2020
    Sponsor
    Januel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04366466
    Brief Title
    Program to Promote Engagement in Care for the Prevention of Recidivism
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Januel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Health Care Seeking Behavior, Case Management

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    138 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    suicide attempt patient who will receive sanitory supervision
    Arm Type
    Other
    Arm Description
    The control group will establish the health monitoring
    Arm Title
    Suicide attempt patient who will participate to PEPS Program
    Arm Type
    Experimental
    Arm Description
    The intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism.
    Intervention Type
    Other
    Intervention Name(s)
    suicide attempt patient using PEPS Program
    Other Intervention Name(s)
    Suicide attempt patient using sanitary supervision
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Clinical Global Impression (CGI)
    Description
    rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
    Time Frame
    Day 0
    Title
    Suicide Intent Scale
    Description
    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.
    Time Frame
    Day 0
    Title
    Montgomery-Asberg depression rating scale
    Description
    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.
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism
    Description
    percentage of all suicidants who relapse during the 12-month study period.
    Time Frame
    1 year
    Title
    Evaluate the level of possible generalization of the program
    Description
    percentage of all suicides of subjects likely to benefit from the program (subjects fulfilling the inclusion and non-inclusion criteria).
    Time Frame
    1 year
    Title
    Evaluate the feasibility of the program
    Description
    percentage of subjects included in the intervention group who received all interventions); weighted by the percentage of acceptance to participate in the study
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Youcef BENCHERIF
    Phone
    01.43.09.32.32
    Email
    y.bencherif@epsve.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rusheenthira THAVASEELAN
    Phone
    0143.0932.32
    Email
    r.thavaseelan@epsve.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fayçal MOUAFFAK
    Organizational Affiliation
    Investigateur Principal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33884617
    Citation
    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.
    Results Reference
    derived

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    Program to Promote Engagement in Care for the Prevention of Recidivism

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