Changes in Digital Phenotype During PE Therapy

• Conditions: PTSD

• Registration Number: NCT04056767
• Lead Sponsor: Nadav Goldental

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14
• Study Start: 2019-09
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Cardiac Output	3 months	Changes in Cardiac Output
Changes in Respiratory rate	3 months	Changes in Respiratory rate
Changes in Stroke Volume	3 months	Changes in Stroke Volume
Changes in Saturation	3 months	Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
Changes in Systemic Vascular Resistance	3 months	Changes in Systemic Vascular Resistance
Changes in sweat	3 months	Changes in Sweat
Changes in Heart Rate	3 months	Heart Rate and HRV (Heart Rate Variability)
Changes in blood pressure	3 months	Changes in Continuous Blood Pressure
Changes in Pulse Pressure	3 months	Changes in Pulse Pressure
Changes in Body Temperature	3 months	Changes in Body Temperature

Secondary Outcome Measures

Name	Time	Method
Correlation between changes in digital phenotype (multiple measures)	3 months	Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires.