Clinical trial NCT02170194: GETSmart: Guided Education and Training Via Smart Phones to Promote Resilience
Official title: GETSmart: Guided Education and Training Via Smart Phones to Promote Resilience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subthreshold PTSD
Keywords: smart phone apps
subthreshold PTSD
resilience enhancement
military veterans
natural disasters
terrorism
shootings
fMRI
physiology
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2014-06-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

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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Primary outcomes:
measure: PTSD Checklist (PCL)
timeFrame: change from baseline at 6 weeks
measure: PTSD Checklist (PCL)
timeFrame: 3 months
measure: PTSD Checklist (PCL)
timeFrame: 6 months
measure: PTSD Checklist (PCL)
timeFrame: 12 months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ)
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: baseline, 3 months
measure: Psychophysiology
timeFrame: baseline, 3 months
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: