Clinical trial NCT03788278: An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder
Official title: An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-traumatic Stress Disorder
Keywords: Digital psychiatry
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18 years and older from both sexes. The study group will include 25 participants with a diagnosis of PTSD. The participants will be recruited from among the patients at the Ministry of Defense clinic at the Sheba Medical Center. The control group will consist of 25 participants recruited from medical staff and students from the Sheba Medical Center and Tel-Aviv University.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Correlations between data changes and PTSD clinical symptoms
timeFrame: Three months
Secondary outcomes:
Other outcomes:
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