Status:

UNKNOWN

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

Lead Sponsor:

Nadav Goldental

Conditions:

Post-traumatic Stress Disorder

Eligibility:

All Genders

18-120 years

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 assess...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

    Key Trial Info

    Start Date :

    August 20 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2019

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT03788278

    Start Date

    August 20 2019

    End Date

    December 1 2019

    Last Update

    August 7 2019

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