An Open-Label, Study of the Feasibility and the Usability of a Software Application to Deliver Targeted Interactive Exercises, in Addition to Treatment as Usual, to Patients Recently Hospitalized for Suicidal Ideation or Suicide Attempts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
The primary objective of this feasibility study is to assess the feasibility, and usability of a software application to deliver targeted interactive exercises to patients recently hospitalized for suicidal ideation or suicide attempts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking male or female patients, 18-70 years
- •Patients who have attempted suicide and voluntarily admitted themselves to an inpatient psychiatric unit or have clinically significant suicidal ideation and intent to harm themselves and are still on the inpatient psychiatric unit.
- •Understand written and spoken English
- •Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
- •Willing and able to complete enrollment procedures
- •Able to understand the nature of the study and provide written informed consent
- •Able and willing to provide at least two verifiable contacts for emergency or tracking purposes.
排除标准
- •Patients with active psychosis
- •Patients who are acutely intoxicated at the time of enrollment
- •Currently enrolled in other treatment studies for the symptoms and behaviors targeted
- •Patients who are cognitively impaired
- •Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit (e.g. critically ill patients) profile with respect to the software application that delivers interactive exercises.
结局指标
主要结局
System Usability Scale (SUS)
时间窗: 16 weeks
The SUS is a valid and reliable, 10-item measure that effectively differentiates between usable and unusable systems. Sample items are "I think that I would like to use this app frequently" and "I felt very confident using the system." Responses are rated using a 5-point (strongly disagree to strongly agree) Likert scale. Scores range from 0 to 100, with a score of 68 being minimal indicator of usability.
User Feedback Interview Questions
时间窗: 16 weeks
Participants will answer the following questions. 1) What did you think about this experience? 2) Do you think you would use this app again if needed? Why (not)? 3) Do you think this app would be useful for helping you with your suicidal thoughts and preventing you from acting on them? Why (not)? Did you think functions were missing in the app? Which ones? 4) Is there anything else you think we should know to make this app better and more user-friendly?
次要结局
- Suicidal ideation(16 weeks)
- Suicide attempts and other behaviors(16 weeks)
- Diagnostic interview(1 week)
- Adverse events(16 weeks)
- Depressive symptoms(16 weeks)