Program to Promote Engagement in Care for the Prevention of Recidivism

NCT04366466 | Unknown DMC

• 1 other identifier: 10477M-PEPS
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Suicide; Health Care Seeking Behavior; Case Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism

  1 year

• Evaluate the level of possible generalization of the program

  1 year

• Evaluate the feasibility of the program

  1 year

Study Arms (2)

suicide attempt patient who will receive sanitory supervision

OTHER

The control group will establish the health monitoring

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.

Other: suicide attempt patient using PEPS Program

Interventions

suicide attempt patient using PEPS Program OTHER

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.

Also known as: Suicide attempt patient using sanitary supervision

Suicide attempt patient who will participate to PEPS Program; suicide attempt patient who will receive sanitory supervision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Januel: lead

Related Publications (1)

• 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.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Suicide; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Fayçal MOUAFFAK

  Investigateur Principal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef BENCHERIF

CONTACT

01.43.09.32.32; y.bencherif@epsve.fr

Rusheenthira THAVASEELAN

CONTACT

0143.0932.32; r.thavaseelan@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research unit

Model Details: Controlled, randomized and prospective study of a cohort of suicide victims comparing an experimental (interventional) group to a control group (usual treatment)

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 29, 2020
• Study Start: May 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share