Clinical trial NCT05534100: Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
Official title: Using Wearable Technology to Detect Symptoms of Posttraumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who either present as a healthy control or are deemed to have PTSD by the CAPS

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5
timeFrame: Through study completion, average of 1 month
measure: PTSD Checklist for DSM-5 Criteria
timeFrame: Through study completion, average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: