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Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder | Clinical Trials | Clareo Health

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Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

NCT05534100•Rush University Medical Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•Individuals are eligible for the current study if they:
•1. Are 18 years or older
•2. Are fluent in English
+3 more criteria

Exclusion Criteria

•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
•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 more criteria

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

November 1, 2022

Primary Completion Date

September 1, 2023

Completion Date

September 1, 2023

Last Updated

October 18, 2023

Enrollment

ACTUAL participants

Conditions

Posttraumatic Stress Disorder

Interventions

Biostrap EVO Wristband

DEVICE

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NCT06219408

Chronic PainPosttraumatic Stress Disorder

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RECRUITINGNA

Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD

NCT07238192

Posttraumatic Stress Disorder (PTSD)Suicidal Ideation+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Inclusion Criteria

Exclusion Criteria

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