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TerminatedNCT05534100Updated Oct 18, 2023

Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

An observational study in Posttraumatic Stress Disorder, sponsored by Rush University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Rush University Medical Center · Observational

Why this study was terminated
Trial discontinued due to unreliable wearable device.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
14
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

03

In context

Stress Disorders, Traumatic

1,148 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 14 is below the median of 140 across 177 observational studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals who either present as a healthy control or are deemed to have PTSD by the CAPS

Inclusion Criteria for participants with PTSD: Individuals are eligible for the current study if they:

  1. Are 18 years or older
  2. Are fluent in English
  3. Have an active smart phone or smart device with full data and Bluetooth capability
  4. Have experienced a Criterion A traumatic event during their lifetime
  5. Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5 and a symptom severity score of 35 or higher.
  6. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
  7. Are willing to wear a smart device 24/7 over the course of one month.

Exclusion Criteria for PTSD participants: Individuals are excluded from the current study if:

  1. The traumatic event occurred in the past month
  2. They are currently suicidal or homicidal
  3. They have a history of psychosis or mania
  4. They have a known, diagnosed heart condition
  5. They are currently receiving treatment for their PTSD or have completed an evidence- based PTSD treatment in the past 3 months
  6. They have a serious or unstable medical illness or instability for which hospitalization may be likely
  7. 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 study

Inclusion criteria

Inclusion Criteria for healthy controls:

Individuals are eligible for the current study if they:

  1. Are 18 years or older
  2. Are fluent in English
  3. Have an active smart phone or smart device with full data and Bluetooth capability
  4. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
  5. Are willing to wear a smart device 24/7 over the course of one month.

Exclusion criteria

Exclusion Criteria for healthy controls:

Individuals are excluded from the current study if they:

  1. Score a 10 or higher on the Clinician Administered PTSD Scale for DSM-5
  2. Known or diagnosed heart condition
  3. Known or diagnosed psychiatric condition
  4. Currently or have previously received psychiatric care in the past 3 months
  5. 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Control

    Device: Biostrap EVO Wristband

  • PTSD

    Device: Biostrap EVO Wristband

Interventions

  • DeviceBiostrap EVO Wristband

    Participants in both groups will wear the Biostrap wearable device

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What researchers measure

Primary outcomes

  1. Clinician Administered PTSD Scale for DSM-5

    Clinician administered measure of PTSD

    Time frame: Through study completion, average of 1 month

  2. PTSD Checklist for DSM-5 Criteria

    Self-report measure of PTSD

    Time frame: Through study completion, average of 1 month

07

Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05534100
Lead sponsor
Rush University Medical Center
Responsible party
Philip Held (Research Director, Rush University Medical Center) — Principal investigator
First posted
Sep 9, 2022
Start date
Nov 1, 2022
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023
Last update
Oct 18, 2023

Oversight

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

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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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