Changes in Digital Phenotype During PE Therapy

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

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).

Study Overview

• Status: Unknown
• Conditions: PTSD

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Imaginal PE
Writing PE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nadav Goldental

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 6269-19-SMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No