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

Posttraumatic stress disorder (PTSD) has been identified in 10-20% of U.S. military service
members (SMs) returning from Afghanistan and Iraq, and is associated with impaired physical
health, mental health, and overall functional status. Resilience has often been spoken of,
yet proven methods for promoting resilience, and protecting SMs from PTSD, have yet to be
established. One easy and effective way of identifying those at higher risk for development
of PTSD is through the one-page, 17-item self-administered PTSD Checklist (PCL). The total
score can range from 17 to 85, and a score of 50 is the best cut-off for making a diagnosis
of PTSD, but there are many military SMs who have impaired function associated with scores
below this level. There have also been some high-profile fatal shootings on military
installations in recent years, including Fort Hood, TX, and the Washington Naval Yard in the
District of Columbia, and such incidents tend to be followed by persistent symptoms in many
individuals who were in the vicinity at the time. There is limited recent evidence to
suggest that lower intensity intervention might be effective in those with subthreshold
PTSD, even though it does not necessarily successfully treat fully developed PTSD. We will
therefore conduct a randomized controlled clinical trial involving 144 individuals who are
eligible for care in the military healthcare system who report subthreshold PCL scores (28
to 49), either within five years after their return from Afghanistan or Iraq, or after being
affected in some significant way by a terrifying incident such as a bombing or shooting, or
a major natural disaster that results in significant loss of life such as a hurricane,
tornado, or earthquake. Seventy-two participants will be assigned to the resilience
enhancement group, which will be initiated with a single 90-minute introduction to both
cognitive behavioral therapy (CBT) techniques and the use of smart-phone based applications
(apps) that promote increased resilience through relaxation, biofeedback, psychoeducation
and other techniques. Over the subsequent 6 weeks, daily text messages to all participants
will accentuate the positive, including providing recommendations on beneficial activities,
fostering behavioral changes, and in particular encouraging the completion of smart
phone-based applications (apps). The control group (n=72) will be provided with an initial
informational session providing them with details of where they can get help if they have
worsened symptoms over time. They will receive daily texts with aphorisms for 6 weeks.
Symptoms will be re-assessed with the PCL by personal computer (PC), tablet or smartphone
based access to the NIH Clinical Trials Survey System (CTSS) for both the resilience
enhancement and control groups at the end of each week in the 6-week training period. In
addition the GAD, PHQ-9, and PCL will be assessed at baseline and 6weeks and at 3, 6 and 12
months. We anticipate that this relatively inexpensive resilience enhancement program will
reduce the incidence of PTSD over the initial 6 weeks by 20% compared to the control group,
and that this improvement will be maintained over the subsequent year. We further expect
that the training program will be associated with a reduction in the incidence of PTSD by at
least 10% over the follow-up period. Our power estimates indicate that with 72 participants
each in the resilience enhancement and control groups, we will have 90% power to identify a
significant difference between the two groups with 95% confidence (p < 0.05). For
approximately 20% of participants (n=30; 15 in each group) we will perform psychophysiologic
measures and functional MRI of the brain using the Affective Stroop paradigm at baseline and
again 3-6 months later to assess for changes with resilience enhancement.

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.

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.