Posttraumatic Stress DisorderNCT05534100
Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
An observational study of Posttraumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
Trial summary
The aim of the project is to advance our understanding of how individuals with Posttraumatic Stress Disorder (PTSD) experience symptoms in their every-day lives when they are in their home environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Biostrap EVO Wristband
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Sep 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who either present as a healthy control or are deemed to have PTSD by the CAPS
Who may be able to join
- Individuals are eligible for the current study if they:
- Are 18 years or older
- Are fluent in English
- Have an active smart phone or smart device with full data and Bluetooth capability
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
- Are willing to wear a smart device 24/7 over the course of one month.
Who cannot join
- Individuals are excluded from the current study if they:
- Score a 10 or higher on the Clinician Administered PTSD Scale for DSM-5
- Known or diagnosed heart condition
- Known or diagnosed psychiatric condition
- Currently or have previously received psychiatric care in the past 3 months
- Subjects who, at the time of consent, appear to have extenuating life circumstances (unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect their ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The aim of the project is to advance our understanding of how individuals with Posttraumatic Stress Disorder (PTSD) experience symptoms in their every-day lives when they are in their home environment. To date, all PTSD assessments are retrospective; individuals with PTSD are asked to recount and report their symptoms over the past weeks or months. Such assessment procedures are negatively impacted by individuals' abilities to accurately recall information. Moreover, retrospective assessments provide little information about how symptoms are experienced in the moment and how these experiences then lead to other behaviors. The proposed project addresses these limitations by assessing PTSD symptoms and associated biological markers (e.g., sleep, heart rate, heart rate variability) in real-time by asking subjects to wear a smart device and complete brief surveys. Data will be collected from 50 individuals with PTSD and 20 healthy controls to help us better understand individuals' real-time experience with PTSD and lay the foundation to develop algorithms for possible in-the-moment interventions in the future.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Biostrap EVO Wristband
- 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.
Biostrap EVO WristbandDevice
Participants in both groups will wear the Biostrap wearable device
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Not described Receives: Device: Biostrap EVO Wristband | |
| PTSD | Not described Receives: Device: Biostrap EVO Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5
Clinician administered measure of PTSD
Measured: Through study completion, average of 1 month
PTSD Checklist for DSM-5 Criteria
Self-report measure of PTSD
Measured: Through study completion, average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Trial discontinued due to unreliable wearable device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Held, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534100
- Sponsor's protocol ID
- 21090706
- Status last verified
- Oct 2023
- First submitted
- 6 Sep 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05534100
- Acronym / sponsor ID
- 21090706
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Trial discontinued due to unreliable wearable device.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 9 Sep 2022 (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.
The aim of the project is to advance our understanding of how individuals with Posttraumatic Stress Disorder (PTSD) experience symptoms in their every-day lives when they are in their home environment. To date, all PTSD assessments are retrospective; individuals with PTSD are asked to recount and report their symptoms over the past weeks or months. Such assessment procedures are negatively impacted by individuals' abilities to accurately recall information. Moreover, retrospective assessments provide little information about how symptoms are experienced in the moment and how these experiences then lead to other behaviors. The proposed project addresses these limitations by assessing PTSD symptoms and associated biological markers (e.g., sleep, heart rate, heart rate variability) in real-time by asking subjects to wear a smart device and complete brief surveys. Data will be collected from 50 individuals with PTSD and 20 healthy controls to help us better understand individuals' real-time experience with PTSD and lay the foundation to develop algorithms for possible in-the-moment interventions in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: Biostrap EVO Wristband |
| PTSD | – | Device: Biostrap EVO Wristband |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who either present as a healthy control or are deemed to have PTSD by the CAPS
Key inclusion criteria (6 listed)
- Are 18 years or older
- Are fluent in English
- Have an active smart phone or smart device with full data and Bluetooth capability
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
- Are willing to wear a smart device 24/7 over the course of one month.
Key exclusion criteria (6 listed)
- Score a 10 or higher on the Clinician Administered PTSD Scale for DSM-5
- Known or diagnosed heart condition
- Known or diagnosed psychiatric condition
- Currently or have previously received psychiatric care in the past 3 months
- Subjects who, at the time of consent, appear to have extenuating life circumstances (unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect their ability to participate in the trial
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 |
|---|---|---|
| Biostrap EVO WristbandParticipants in both groups will wear the Biostrap wearable device | Device | Healthy Control, PTSD |
Primary outcome
Clinician Administered PTSD Scale for DSM-5
Time frame: Through study completion, average of 1 month
Clinician administered measure of PTSD
PTSD Checklist for DSM-5 Criteria
Time frame: Through study completion, average of 1 month
Self-report measure of PTSD
Results and safety
The study was stopped early (reason given: Trial discontinued due to unreliable wearable device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Trial discontinued due to unreliable wearable device.). 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?
Clinician Administered PTSD Scale for DSM-5 (time frame: Through study completion, average of 1 month). The study lists 2 primary outcomes in all. 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 18 Oct 2023.