ClinicalTrials.gg
Status unknownNCT04169958Updated Nov 20, 2019

Suicide Risk Assessment by Digital Means

An observational study in Suicide, sponsored by The Chaim Sheba Medical Center. Status unknown. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by The Chaim Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.

The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).

The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.

After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.

Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.

02

Conditions studied

  • Suicide

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03

In context

Suicide

607 studies on the registry are indexed under Suicide; 162 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 98 observational studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

The Chaim Sheba Medical Center is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We will recruit a total sample of N=50 in three stages:

  • Males and Females
  • 30 patients aged 12 - 18 years old (20% of the study sample) Participants will be recruited from the psychiatric ER (\~50%), outpatient clinics (\~20%), and inpatient wards (\~30%) at the Sheba Medical Center, the largest hospital in Israel, serving a very large, demographically heterogenic and socioeconomically diverse population.
  • Psychiatric diagnosis: None, Affective Disorder, PTSD, ADHD, Personality Disorder, Anxiety Disorder, OCD.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Every patient who is examined in the psychiatric ward at the Sheba Medical Center
  • Proper ability to give

Exclusion criteria

Exclusion Criteria:

  • A patient who is not independent and without an active therapist / guardian involved in the treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Othersafe mood

    A tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide

06

What researchers measure

Primary outcomes

  1. Correlations between collected digital data and suicidality rating score

    Correlations between collected digital data and suicidality rating score.

    Time frame: 1.5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2020; primary completion for Nov 2020, 9 months later.

Of 35 non-industry observational studies under Suicide, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 93. This study's planned 9 months is below that.

Counting every sponsor, half of 37 studies reached it within 51 months; a quarter within 28 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2018
First posted
Nov 20, 2019
StartEst.
Feb 1, 2020
Primary completionEst.
Nov 29, 2020
CompletionEst.
Dec 30, 2020
Last update
Nov 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04169958
Lead sponsor
The Chaim Sheba Medical Center
Responsible party
Nadav Goldental (Principal Investigator, The Chaim Sheba Medical Center) — Principal investigator
First posted
Nov 20, 2019
Start date
Feb 1, 2020 (estimated)
Primary completion
Nov 29, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Nov 20, 2019

Study contacts

NADAV GOLDENTAL, MD
Contact
nadav.gold@gmail.com
+972-503363498

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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