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

NCT02170194 | Unknown DMC

• 2 other identifiers: 388404399461
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Subthreshold PTSD

Keywords

smart phone apps; subthreshold PTSD; resilience enhancement; military veterans; natural disasters; terrorism; shootings; fMRI; physiology

Outcome Measures

Primary Outcomes (4)

• PTSD Checklist (PCL)

  The PCL is a self-administered screen for PTSD (used both as a brief initial screen to confirm eligibility, and to provide a brief alternative in case some participants are unable to complete the more cumbersome CAPS at one or more follow-up intervals; demonstrates); a recent assessment of its psychometric properties in male veterans found very high internal consistency and convergent validity with the gold-standard CAPS (correlation, r=0.79). It should be noted that there is a military version of the PCL which we have used in prior studies that have involved solely military service members, the only difference between the military version and the more generalizable "civilian" version is the inclusion of the word "military" prior to "stressful experience" for 6 of the 17 items, so that there should not be a significant difference in the responses of service members who complete the civilian version, whereas the military version would not make sense for civilian participants

  change from baseline at 6 weeks

• PTSD Checklist (PCL)

  The PCL is a self-administered screen for PTSD (used both as a brief initial screen to confirm eligibility, and to provide a brief alternative in case some participants are unable to complete the more cumbersome CAPS at one or more follow-up intervals; demonstrates); a recent assessment of its psychometric properties in male veterans found very high internal consistency and convergent validity with the gold-standard CAPS (correlation, r=0.79). It should be noted that there is a military version of the PCL which we have used in prior studies that have involved solely military service members, the only difference between the military version and the more generalizable "civilian" version is the inclusion of the word "military" prior to "stressful experience" for 6 of the 17 items, so that there should not be a significant difference in the responses of service members who complete the civilian version, whereas the military version would not make sense for civilian participants

  3 months

• PTSD Checklist (PCL)

  The PCL is a self-administered screen for PTSD (used both as a brief initial screen to confirm eligibility, and to provide a brief alternative in case some participants are unable to complete the more cumbersome CAPS at one or more follow-up intervals; demonstrates); a recent assessment of its psychometric properties in male veterans found very high internal consistency and convergent validity with the gold-standard CAPS (correlation, r=0.79). It should be noted that there is a military version of the PCL which we have used in prior studies that have involved solely military service members, the only difference between the military version and the more generalizable "civilian" version is the inclusion of the word "military" prior to "stressful experience" for 6 of the 17 items, so that there should not be a significant difference in the responses of service members who complete the civilian version, whereas the military version would not make sense for civilian participants

  6 months

• PTSD Checklist (PCL)

  The PCL is a self-administered screen for PTSD (used both as a brief initial screen to confirm eligibility, and to provide a brief alternative in case some participants are unable to complete the more cumbersome CAPS at one or more follow-up intervals; demonstrates); a recent assessment of its psychometric properties in male veterans found very high internal consistency and convergent validity with the gold-standard CAPS (correlation, r=0.79). It should be noted that there is a military version of the PCL which we have used in prior studies that have involved solely military service members, the only difference between the military version and the more generalizable "civilian" version is the inclusion of the word "military" prior to "stressful experience" for 6 of the 17 items, so that there should not be a significant difference in the responses of service members who complete the civilian version, whereas the military version would not make sense for civilian participants

  12 months

Secondary Outcomes (1)

• Patient Health Questionnaire (PHQ)

  baseline, 6 weeks, 3 months, 6 months, 12 months

Other Outcomes (2)

• Functional magnetic resonance imaging (fMRI)

  baseline, 3 months

• Psychophysiology

  baseline, 3 months

Study Arms (2)

Resilience Enhancement Group

EXPERIMENTAL

The resilience enhancement group will begin with a 90-minute session with the study psychologist, which will include a brief introduction to cognitive behavioral therapy (CBT), but focus primarily on psychoeducational, relaxation techniques and planning positive activities. The majority of the time will be focused on reviewing techniques that promote stress management. Emphasis will be placed on relaxation approaches such as controlled breathing, meditation and yoga. Focus will also be aimed at reviewing how engagement in positive activities may help prevent avoidance, promote social support and wellness. Over the subsequent 6 weeks, daily text messages to all participants will accentuate the positive, including providing recommendations on beneficial activities to engage in, encouraging such activities including in vivo exposure, and fostering behavioral changes.

Behavioral: Resilience Enhancement Training via Smart Phone

Control Group

PLACEBO COMPARATOR

The control group 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. In addition, the psychologist will briefly review the apps, but not provide the same pscyhoeducational detail given to the resilience enhancement group. They will receive daily texts with inspirational aphorisms (e.g., "Early to bed and early to rise makes a man healthy, wealthy, and wise.") for 6 weeks.

Behavioral: Daily Text Messages

Interventions

Resilience Enhancement Training via Smart Phone BEHAVIORAL

Resilience Enhancement Group

Daily Text Messages BEHAVIORAL

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Links

• Center for Neuroscience and Regenerative Medicine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 23, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)