Post-traumatic Stress Disorder
Conditions
Keywords
Digital psychiatry
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.
Interventions
DEVICEBioBeat
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.
Sponsors
Nadav Goldental
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed