Post-traumatic Stress DisorderNCT03788278
An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder
An observational study of Post-traumatic Stress Disorder, run by Nadav Goldental.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- BioBeat
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2019to 1 Dec 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
- 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).
Who cannot join
- 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).
- 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).
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- 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).
About this study
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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- BioBeat
- Keywords
- Digital psychiatry
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBeatDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BioBeat | |
| 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. Receives: Device: BioBeat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start20 Aug 2019 (estimated)
- Primary completion20 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Nadav Goldental
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadav Goldental, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788278
- Sponsor's protocol ID
- SHEBA-5184-18-SMC
- Status last verified
- Aug 2019
- First submitted
- 3 Dec 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03788278
- Acronym / sponsor ID
- SHEBA-5184-18-SMC
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Digital psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nadav GoldentalUniversity, hospital or other
- Study start
- 20 Aug 2019 (estimated)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD patients | – | Device: BioBeatParticipants 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. |
| Non PTSD participants | – | Device: BioBeatParticipants 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
- Proper ability to give informed consent.
Key exclusion criteria (9 listed)
- 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).
- Current mental health diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioBeatThe 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. | Device | Non PTSD participants, PTSD patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder, run by Nadav Goldental.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between data changes and PTSD clinical symptoms (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.