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Completed

NCT Number: NCT02721316

Outpatient Nurse Monitoring 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supported with intensive nursing follow post hospitalization

Other

Intensive nursing follow post - hospitalization

Primary outcomes

  1. Composite suicidal outcome including suicidal attempt recurrence or hospitalization for suicidal crisis or worsening of suicidal ideation

    Time frame: 12 months from EPAC (Emergency Psychiatry and Acute Care) discharge

    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

Secondary outcomes

  1. Suicide attempt recurrence

    Time frame: 12 months from EPAC discharge

    Occurrence of at least one suicide attempt, defined as medically documented or self-reported attempt or death by suicide

  2. Emergency hospitalization for suicidal crisis without attempt

    Time frame: 12 months from EPAC discharge

    Occurrence of at least one emergency hospitalization for suicidal crisis, defined as persistent and high-intensity suicidal ideations

  3. Worsening of suicidal ideations

    Time frame: 3 months, 6 months and 12 months after EPAC discharge

    Increase ≥2 points on the C-SSRS severity score compared with EPAC discharge

  4. Frequency of suicidal ideation

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and12 months after EPAC discharge

    Frequency of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).

  5. Intensity of suicidal ideation

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge

    Intensity of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).

  6. Psychological pain

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge

    Psychological pain measured with Visual Analog Scale (VAS)

  7. Number of unscheduled healthcare visits for suicidal ideation

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  8. All-cause mortality and mortality by suicide

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  9. Total duration of psychiatric hospitalization during the year following the suicide attempt

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  10. Number of participants lost to follow-up at the end of the study

    Time frame: At 12 months after EPAC discharge

  11. Patient quality of life

    Time frame: At inclusion, at 3 months, 6 months and12 months after EPAC discharge

  12. Adherence to the therapeutic program proposed and/or prescribed in the service.

    Time frame: 12 months after EPAC discharge

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: SIPRéS

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Mar 29, 2016
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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