NCT02664701进行中（未招募）不适用
Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial
Centre Hospitalier Universitaire de Nīmes27 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 27
- 主要终点
- The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.
详细描述
The secondary objectives of this study are to assess the efficacy of CBGT on:
A. parameters describing the incidence of suicide and repeat suicide attempts, as well as suicide re-attempt free follow-up time,
B. long-term changes in suicidal ideation,
C. long-term changes in psychiatric symptoms (depression, hope for the future, hospitalization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been correctly informed
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •French speaking adults (18 years or older) freely hospitalized (in centres or via emergency services) for prevention of suicide and who have a medium or high suicide risk score according to a Mini International Neuropsychiatric Interview structured interview
- •Presence of suicidal ideation according to the Beck Suicide Ideation Scale (score > 3)
- •Prior (or recent) suicide attempt within the last three month
- •The patient is able to understand the study and capable of giving his/her informed consent
- •The patient is available during the weekly time slots proposed by the investigator
排除标准
- •The patient is participating in another study that may interfere with the results or conclusions of this study
- •Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, or is an adult under guardianship
- •The patient refuses to sign the consent, or it is impossible to correctly inform the patient
- •Emergency situations preventing proper study conduct
- •History of schizophrenia or other psychotic troubles
- •Presence of psychotic symptoms at initial interview
- •Serious cognitive impairment
- •Medical incapacity to participate
结局指标
主要结局
The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
时间窗: 12 months
次要结局
- The Columbia suicide severity rating scale (C-SSRS)(12 months)
- Number of suicide re-attempts during the follow-up period.(12 months)
- Completed suicide (yes/no)(12 months)
- Beck Suicide Ideation Scale (BSSI)(12 months)
- Beck Depression Inventory-II (BDI-II)(12 months)
- Beck Hopelessness Scale (BHS)(12 months)
- Cumulative days of hospitalization(12 months)
研究者
研究点 (27)
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