跳至主要内容
临床试验/NCT04366466
NCT04366466Unknown不适用

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.

Januel0 个研究点目标入组 138 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
138
主要终点
Clinical Global Impression (CGI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Clinical Global Impression (CGI)

时间窗: Day 0

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

Montgomery-Asberg depression rating scale

时间窗: 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.

Suicide Intent Scale

时间窗: 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.

次要结局

  • Evaluate the feasibility of the program(1 year)
  • 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)

研究者

发起方
Januel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Januel

Head of clinical research unit

Centre hospitalier de Ville-Evrard, France

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