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Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05534100
Enrollment
14
Registered
2022-09-09
Start date
2022-11-01
Completion date
2023-09-01
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Brief 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.

Interventions

DEVICEBiostrap EVO Wristband

Participants in both groups will wear the Biostrap wearable device

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale for DSM-5Through study completion, average of 1 monthClinician administered measure of PTSD
PTSD Checklist for DSM-5 CriteriaThrough study completion, average of 1 monthSelf-report measure of PTSD

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026