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

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03788278
• Other study ID #: SHEBA-5184-18-SMC
• Status: Not yet recruiting
• Start date: August 20, 2019
• Est. completion date: December 1, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria for study group:

• Current PTSD diagnosis based on DSM-5. We will aim to recruit patients with Clinically Administered PTSD Scale (CAPS)- 5, medium severity and up.

• A person who is being monitored by the Ministry of Defense PTSD clinic at the Sheba Medical Center.

• Proper ability to give informed consent.

• A person with a smartphone that is not hacked with an Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Inclusion Criteria for control group:

• Proper ability to give informed consent.

• A person with a smartphone that is not hacked with an Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Exclusion Criteria for study group:

• A person defined as a violent or suicidal person (significant events of physical violence or suicidal behavior in the past year, according to the treating psychiatrist professional opinion).

• An active or terminal oncology disease or a dialysis patient.

• A person who is not independent or reports that he/she will not meet the requirement to wear the watch, recharge it or any other requirement arising from the use of the watch.

• A person without a smartphone that is not hacked or without Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Exclusion Criteria for control group:

• Current mental health diagnosis.

• A person defined as a violent or suicidal person (significant events of physical violence or suicidal behavior in the past year, according to the treating psychiatrist professional opinion).

• An active or terminal oncology disease or a dialysis patient.

• A person who is not independent or reports that he/she will not meet the requirement to wear the watch, recharge it or any other requirement arising from the use of the watch.

• A person without a smartphone that is not hacked or without Android version 2.3 or higher (relevant to smartphones manufactured since 2011).

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• BioBeat
The watch incorporates sensors, a battery, a software system, memory components, and a communications component. the watch will be worn 24 hours a day, 7 days a week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nadav Goldental

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlations between data changes and PTSD clinical symptoms	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	Three months