Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Terminated

• Conditions: Posttraumatic Stress Disorder
• Interventions: Device: Biostrap EVO Wristband

• Registration Number: NCT05534100
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Study Start: 2022-11-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	Biostrap EVO Wristband	-
PTSD	Biostrap EVO Wristband	-

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale for DSM-5	Through study completion, average of 1 month	Clinician administered measure of PTSD
PTSD Checklist for DSM-5 Criteria	Through study completion, average of 1 month	Self-report measure of PTSD

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States