Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title:

Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05534100
• Other study ID #: 21090706
• Status: Terminated
• Start date: November 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Biostrap EVO Wristband
Participants in both groups will wear the Biostrap wearable device

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5	Clinician administered measure of PTSD	Through study completion, average of 1 month
Primary	PTSD Checklist for DSM-5 Criteria	Self-report measure of PTSD	Through study completion, average of 1 month