跳至主要内容
临床试验/NCT04056767
NCT04056767Unknown不适用

Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch

Nadav Goldental0 个研究点目标入组 100 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Changes in Respiratory rate

研究概览

简要总结

PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.

The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PTSD diagnosis
  • Proper ability to give informed consent

排除标准

  • Active psychotic or suicidal symptoms
  • Severe dissociative symptoms
  • A traumatic brain injury (TBI) diagnosis
  • Pregnancy

结局指标

主要结局

Changes in Respiratory rate

时间窗: 3 months

Changes in Respiratory rate

Changes in Stroke Volume

时间窗: 3 months

Changes in Stroke Volume

Changes in Saturation

时间窗: 3 months

Changes in saturation SPO2 (oxygen saturation by pulse oximetry)

Changes in Systemic Vascular Resistance

时间窗: 3 months

Changes in Systemic Vascular Resistance

Changes in sweat

时间窗: 3 months

Changes in Sweat

Changes in Heart Rate

时间窗: 3 months

Heart Rate and HRV (Heart Rate Variability)

Changes in blood pressure

时间窗: 3 months

Changes in Continuous Blood Pressure

Changes in Pulse Pressure

时间窗: 3 months

Changes in Pulse Pressure

Changes in Body Temperature

时间窗: 3 months

Changes in Body Temperature

Changes in Cardiac Output

时间窗: 3 months

Changes in Cardiac Output

次要结局

  • Correlation between changes in digital phenotype (multiple measures)(3 months)

研究者

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

Nadav Goldental

Principal investigator

The Chaim Sheba Medical Center

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