Changes in Digital Phenotype During PE Therapy

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056767
• Other study ID #: 6269-19-SMC
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: December 2021

Study information

• Verified date: August 2019
• Source: The Chaim Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nadav Goldental

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Heart Rate	Heart Rate and HRV (Heart Rate Variability)	3 months
Primary	Changes in Saturation	Changes in saturation SPO2 (oxygen saturation by pulse oximetry)	3 months
Primary	Changes in blood pressure	Changes in Continuous Blood Pressure	3 months
Primary	Changes in Pulse Pressure	Changes in Pulse Pressure	3 months
Primary	Changes in Respiratory rate	Changes in Respiratory rate	3 months
Primary	Changes in Stroke Volume	Changes in Stroke Volume	3 months
Primary	Changes in Systemic Vascular Resistance	Changes in Systemic Vascular Resistance	3 months
Primary	Changes in sweat	Changes in Sweat	3 months
Primary	Changes in Body Temperature	Changes in Body Temperature	3 months
Primary	Changes in Cardiac Output	Changes in Cardiac Output	3 months
Secondary	Correlation between changes in digital phenotype (multiple measures)	Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires.	3 months