Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

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 Overview

• Status: Terminated
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Device: Biostrap EVO Wristband

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control	Device: Biostrap EVO Wristband; Participants in both groups will wear the Biostrap wearable device
PTSD	Device: Biostrap EVO Wristband; Participants in both groups will wear the Biostrap wearable device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 21090706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No