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临床试验/NCT03950765
NCT03950765Unknown不适用

Real-time Intervention for Suicide Risk Reduction

Harvard University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Change in momentary levels of self-reported distress

研究概览

简要总结

The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital.

详细描述

The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital. During the time they are in the study, participants will be asked to install on their smartphone a mobile application to deliver the therapeutic content and will wear a physiological monitoring device on their wrist (Empatica Embrace) which will monitor objective signals of physiological distress (e.g., skin conductance).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ecological Momentary Intervention

Experimental

This group will receive three intervention prompts and three assessment prompts on their smartphone each day.

干预措施: Ecological momentary intervention (Behavioral)

结局指标

主要结局

Change in momentary levels of self-reported distress

时间窗: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Assessed via smartphone assessments

Change in momentary levels of physiological distress

时间窗: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Skin conductance (assessed with wearable device)

Change in momentary levels of suicidal thinking

时间窗: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Assessed via smartphone assessments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evan Kleiman

Principal Investigator

Harvard University

研究点 (2)

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