Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PTSD
- Sponsor
- Nadav Goldental
- Enrollment
- 100
- Primary Endpoint
- Changes in Respiratory rate
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
Nadav Goldental
Principal investigator
The Chaim Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- •PTSD diagnosis
- •Proper ability to give informed consent
Exclusion Criteria
- •Active psychotic or suicidal symptoms
- •Severe dissociative symptoms
- •A traumatic brain injury (TBI) diagnosis
- •Pregnancy
Outcomes
Primary Outcomes
Changes in Respiratory rate
Time Frame: 3 months
Changes in Respiratory rate
Changes in Stroke Volume
Time Frame: 3 months
Changes in Stroke Volume
Changes in Saturation
Time Frame: 3 months
Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
Changes in Systemic Vascular Resistance
Time Frame: 3 months
Changes in Systemic Vascular Resistance
Changes in sweat
Time Frame: 3 months
Changes in Sweat
Changes in Heart Rate
Time Frame: 3 months
Heart Rate and HRV (Heart Rate Variability)
Changes in blood pressure
Time Frame: 3 months
Changes in Continuous Blood Pressure
Changes in Pulse Pressure
Time Frame: 3 months
Changes in Pulse Pressure
Changes in Body Temperature
Time Frame: 3 months
Changes in Body Temperature
Changes in Cardiac Output
Time Frame: 3 months
Changes in Cardiac Output
Secondary Outcomes
- Correlation between changes in digital phenotype (multiple measures)(3 months)