GETSmart: Guided Education and Training Via Smart Phones to Promote Resilience

Status unconfirmed · Not applicable

Conditions studied: Subthreshold PTSD

In brief

There is no question that combat and domestic attacks can be stressful, and can have effects that last for months or even years, including reliving some of the events through nightmares or flashbacks, wanting to avoid anything that is a reminder of combat or domestic attack such as movies or the nightly news, or being jumpy and concerned about security. When someone has a lot of these symptoms they might be told they have PTSD, but even when that person doesn't have the full condition, just having some symptoms can affect their ability to function at the highest level at home, work, or in social settings, and puts you at greater risk for developing full PTSD. While someone who went through a significant stressful event might not need a long course of therapy if they don't have full PTSD, the investigator of this study thinks that working with them from a distance through their smart phone over time may decrease their symptoms, help them feel better, and prevent full PTSD. Thus the purpose of this study is to assess how a brief, relatively simple resiliency enhancement strategy, provided mostly through smart phones, affects someone with stress-related symptoms.

Key facts

Study ID

NCT02170194

Run by

Walter Reed National Military Medical Center

People needed

144

Starts

2014-05-01

Expected to finish

2016-12-01

Last updated by the study team

2016-11-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• PTSD Checklist (PCL) score must be in the range of 28 to 49 at baseline.
• 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.
• No active PTSD diagnosis. This will be assessed by asking the participant and confirmed by the screening PCL and the baseline PCL.

You may not qualify if…

• 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:
• 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.
• 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;
• 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.
• 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.
• Those who are not eligible for care in the military healthcare system (DEERS-eligible) will be excluded from the in-person assessments.

Where it is running

• Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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