Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05534100
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Device: Biostrap EVO Wristband

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2026
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Clinician Administered PTSD Scale for DSM-5 [Through study completion, average of 1 month]

   Clinician administered measure of PTSD

2. PTSD Checklist for DSM-5 Criteria [Through study completion, average of 1 month]

   Self-report measure of PTSD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Held, Research Director, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT05534100
• Other Study ID Numbers: 21090706
• First Posted: Sep 9, 2022
• Last Update Posted: Sep 9, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 9, 2022