Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
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
- 否
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
Nadav Goldental
Principal investigator
The Chaim Sheba Medical Center