Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

NCT05534100 | Terminated DMC

• 1 other identifier: 21090706
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale for DSM-5

  Clinician administered measure of PTSD

  Through study completion, average of 1 month

• PTSD Checklist for DSM-5 Criteria

  Self-report measure of PTSD

  Through study completion, average of 1 month

Study Arms (2)

Healthy Control

Device: Biostrap EVO Wristband

PTSD

Device: Biostrap EVO Wristband

Interventions

Biostrap EVO Wristband DEVICE

Participants in both groups will wear the Biostrap wearable device

Healthy Control; PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Are 18 years or older
• Are fluent in English
• Have an active smart phone or smart device with full data and Bluetooth capability
• Have experienced a Criterion A traumatic event during their lifetime
• Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5 and a symptom severity score of 35 or higher.
• 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.

You may not qualify if:

• The traumatic event occurred in the past month
• They are currently suicidal or homicidal
• They have a history of psychosis or mania
• They have a known, diagnosed heart condition
• They are currently receiving treatment for their PTSD or have completed an evidence- based PTSD treatment in the past 3 months
• They have a serious or unstable medical illness or instability for which hospitalization may be likely
• 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 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.
• Individuals are excluded from the current study if they:
• Score a 10 or higher on the Clinician Administered PTSD Scale for DSM-5

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)