Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT05534100
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05534100
Study Brief:
Protocol Section:
NCT05534100