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

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ClinicalTrials.gov Identifier: NCT03788278
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Nadav Goldental, The Chaim Sheba Medical Center

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.

Condition or disease Intervention/treatment
Post-traumatic Stress Disorder Device: BioBeat

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder
Estimated Study Start Date : August 20, 2019
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PTSD patients

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.

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.

Non PTSD participants

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.

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.




Primary Outcome Measures :
  1. Correlations between data changes and PTSD clinical symptoms [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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).

Additional Information:

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Responsible Party: Nadav Goldental, Principal investigator, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03788278    
Other Study ID Numbers: SHEBA-5184-18-SMC
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nadav Goldental, The Chaim Sheba Medical Center:
Digital psychiatry
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders