NCT05144685终止2 期
A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 356
- 试验地点
- 12
- 主要终点
- Columbia-Suicide Severity Rating Scale(C-SSRS)
研究概览
简要总结
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.
详细描述
This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and research assessors will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ≥18 years old
- •Patients recently hospitalized.
- •Owns a smartphone.
- •Willing and able to complete enrollment procedures.
- •Able to understand the nature of the study.
- •Able and willing to provide at least two verifiable contacts.
排除标准
- •Patients who have untreated psychosis or active psychosis
- •Patients who appear to be impaired by the use of alcohol or other substance(s)
- •Patients who sign, or have signed, an informed consent form to participate in any clinical research
- •Patients who upon clinical examination are cognitively impaired
- •Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete
结局指标
主要结局
Columbia-Suicide Severity Rating Scale(C-SSRS)
时间窗: Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104
The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.
次要结局
未报告次要终点
研究者
研究点 (12)
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