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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02170194
Eligibility Criteria:
Inclusion Criteria:
1. Participants must have had a deployment in Iraq or Afghanistan or exposure to a stressful event such as a domestic terrorist incident or natural disaster.
2. Participants must be in the United States and have an I-phone or Android platform smart phone and a service plan that includes the ability to receive text messages.
3. PTSD Checklist (PCL) score must be in the range of 28 to 49 at baseline.
4. No active suicidal ideation, as manifest by a response of "not at all" to the PHQ-9 question, "Over the past 2 weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?" .This will be assessed after written informed consent is attained.
5. No active PTSD diagnosis. This will be assessed by asking the participant and confirmed by the screening PCL and the baseline PCL.
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Exclusion Criteria:
All participants must adhere to the above inclusion criteria. However for those wishing to taking part in the on-site assessment, the following additional exclusion criteria will prevent them from taking part in the on-site fMRI and physiologic assessments, though they will still be able to take part in the GETSmart resilience enhancement vs. control groups:
1. Pregnancy: urine pregnancy tests will be performed on all females prior to the conduct of imaging studies both at baseline and follow-up assessments; women with positive tests upon baseline assessment will be excluded from the on-site assessment element; if a positive pregnancy test is identified at the follow up in-person assessment, the physiologic element will still be conducted but the MRI will not be performed.
2. Individuals with shrapnel, body piercings that cannot be removed, or other imbedded metal resulting from either trauma or surgical procedures will be excluded from the in-person assessments due to the risk or displacement of metal with magnetic resonance imaging;
3. Those with significant claustrophobia, including but not limited to intolerance of magnetic resonance imaging in the past, will be excluded from the in-person assessments, as we cannot provide sedating medications with the scans due to the potential impact of the medications on interpretation of scan results.
4. Individuals who are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha blockers (e.g., prazosin, terazosin) who are unable to hold these medications for a 24-hour period prior to scanning, will be excluded from the in-person assessments due to the impact of these medications on the interpretation of fMRI imaging.
5. Those who are not eligible for care in the military healthcare system (DEERS-eligible) will be excluded from the in-person assessments.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02170194
Study Brief:
Protocol Section:
NCT02170194