An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder

• Conditions: Post-traumatic Stress Disorder
• Interventions: Device: BioBeat

• Registration Number: NCT03788278
• Lead Sponsor: Nadav Goldental

Brief Summary

Psychiatric diagnosis is based mainly on questioning the patient and subjective impression rather than a quantitative assessment. The assessment is usually done with long time intervals between assessments and arbitrary in relation to the clinical course of the disorder. Post-traumatic stress disorder has physiological, physical, and behavioral manifestations. These changes appear as a response to different situations during the day and can be measured directly and indirectly in order to obtain an objective, quantitative and fuller picture of the severity and changes in the disorder. This is a non-interventional pilot study, using a system that collects data through wearable sensors and smartphone over a long period of time for patients suffering from PTSD and enables data analysis and characterization of a personal digital phenotype using a dedicated algorithm. Based on this pattern, the investigators will attempt to support the establishment of the PTSD diagnosis. During the course of the study, the therapeutic procedure will not be affected by the study and will be independent of the research.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Study Start: 2019-08-20
• Primary Completion: 2019-10-20
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non PTSD participants	BioBeat	Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires. Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days. Participants will be required to answer digital questionnaires twice a day via smartphone.
PTSD patients	BioBeat	Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires. Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days. Participants will be required to answer digital questionnaires twice a day via smartphone.

Primary Outcome Measures

Name	Time	Method
Correlations between data changes and PTSD clinical symptoms	Three months	Investigators will use a wearable smart watch to collect physiological data (Heart Rate, Cardiac Output, Blood Pressure, Respiratory Rate, Steps Counter, Electro-Dermal Activity) and will use psychiatric rating score (CAPS 5, CGI, PHQ-SADS) to determine changes in clinical symptoms. The investigators will look for correlations between the collected physiological data and the clinical symptoms according to the psychiatric rating scales