Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal (SIPRéS)

Randomized Study of Ambulatory Monitoring Nurse Under the Prevention of Recurrent Suicidal

To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.

Study Overview

• Status: Completed
• Conditions: Mood Disorder; Reactive Depression
• Intervention / Treatment: Other: Supported with intensive nursing follow post hospitalization

Detailed Description

Main objective: To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.

Secondary objectives:

Studying during the year following the suicide attempt index, the impact of this device on:

• The frequency and intensity of suicidal ideation
• the spontaneous use of emergency care
• the death rate from suicide and other causes
• the cumulative duration of hospitalization for suicidal behavior
• The patient's quality of life
• the number of patients lost to at the end of search

Studying patient compliance with intensive nursing monitoring program.

To study the role of the nurse to determine the factors that promote the construction of a therapeutic alliance.

Establish a mapping of needs and resources suicidal patient for nursing care in post-emergency.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide

Exclusion Criteria:

• Patients with bipolar disorder, current episode manic in
• Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS
• Patient suffering from a somatic pathology associated with the prognosis is committed in the short term.
• Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types.
• Homeless Patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supported with intensive nursing follow; Supported with intensive nursing follow post hospitalization the team of hospital output of the unit to 12 weeks after discharge. These interviews will be conducted at the hospital, at home or by phone and their pace will be adjusted according to the patient's condition. The expected duration of close outpatient follow-up is of maximum 3 months.	Other: Supported with intensive nursing follow post hospitalization; Intensive nursing follow post - hospitalization
No Intervention: usual care; For control patients, monitoring will be identical to their usual care as part of their pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite suicidal outcome including suicidal attempt recurrence or hospitalization for suicidal crisis or worsening of suicidal ideation	Composite endpoint including any of the following events: Suicide attempt recurrence,; Emergency hospitalization for suicidal crisis without suicide attempt; Worsening of suicidal ideations defined as an increase ≥2 points on the C-SSRS severity subscale compared with EPAC discharge	12 months from EPAC (Emergency Psychiatry and Acute Care) discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide attempt recurrence	Occurrence of at least one suicide attempt, defined as medically documented or self-reported attempt or death by suicide	12 months from EPAC discharge
Emergency hospitalization for suicidal crisis without attempt	Occurrence of at least one emergency hospitalization for suicidal crisis, defined as persistent and high-intensity suicidal ideations	12 months from EPAC discharge
Worsening of suicidal ideations	Increase ≥2 points on the C-SSRS severity score compared with EPAC discharge	3 months, 6 months and 12 months after EPAC discharge
Frequency of suicidal ideation	Frequency of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).	At inclusion, at EPAC discharge, and at 3 months, 6 months and12 months after EPAC discharge
Intensity of suicidal ideation	Intensity of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).	At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Psychological pain	Psychological pain measured with Visual Analog Scale (VAS)	At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Number of unscheduled healthcare visits for suicidal ideation		At 3 months, 6 months and12 months after EPAC discharge
All-cause mortality and mortality by suicide		At 3 months, 6 months and12 months after EPAC discharge
Total duration of psychiatric hospitalization during the year following the suicide attempt		At 3 months, 6 months and12 months after EPAC discharge
Number of participants lost to follow-up at the end of the study		At 12 months after EPAC discharge
Patient quality of life		At inclusion, at 3 months, 6 months and12 months after EPAC discharge
Adherence to the therapeutic program proposed and/or prescribed in the service.		12 months after EPAC discharge

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Grégory Mykolow, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimated): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Mood Disorders; Adjustment Disorders; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: UF9533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED