Subthreshold PTSDGETSmartNCT02170194
GETSmart: Guided Education and Training Via Smart Phones to Promote Resilience
A study testing Resilience Enhancement Training via Smart Phone and Daily Text Messages in people with Subthreshold PTSD, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subthreshold PTSD
- What is being tested?
- Resilience Enhancement Training via Smart Phone and Daily Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
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.
Read the 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.
- Conditions
- Subthreshold PTSD
- Being tested
- Resilience Enhancement Training via Smart Phone, Daily Text Messages
- Keywords
- smart phone apps, subthreshold PTSD, resilience enhancement, military veterans, natural disasters, terrorism, shootings, fMRI, physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Enhancement Training via Smart PhoneBehavioural
Daily Text MessagesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Daily Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (1)
Patient Health Questionnaire (PHQ)
The PHQ-9 is a brief screening instrument that is widely used to screen for and monitor the severity of depression. The GAD-7 provides similar validate efficacy in the screening and monitoring of anxiety spectrum disorders including generalized anxiety disorder, panic, social anxiety, and posttraumatic stress disorder. Both are elements of the PHQ, which was initially validated in 3000 primary care patients, including 500 at Walter Reed, where the PI of this protocol was the site PI.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170194
- Sponsor's protocol ID
- 388404
- Other IDs
- 399461
- Acronym
- GETSmart
- Status last verified
- Oct 2016
- First submitted
- 9 Jun 2014
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GETSmart: Guided Education and Training Via Smart Phones to Promote Resilience
- ClinicalTrials.gov ID
- NCT02170194
- Acronym / sponsor ID
- GETSmart / 388404
- Conditions
- Subthreshold PTSD
- Keywords
- smart phone apps, subthreshold PTSD, resilience enhancement, military veterans, natural disasters, terrorism, shootings, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience Enhancement Group | Experimental | Behavioral: Resilience Enhancement Training via Smart PhoneThe 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. |
| Control Group | Placebo comparator | Behavioral: Daily Text MessagesThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience Enhancement Training via Smart Phone | Behavioural | Resilience Enhancement Group |
| Daily Text Messages | Behavioural | Control Group |
Primary outcome
PTSD Checklist (PCL)
Time frame: change from baseline at 6 weeks
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
PTSD Checklist (PCL)
Time frame: 3 months
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
PTSD Checklist (PCL)
Time frame: 6 months
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
PTSD Checklist (PCL)
Time frame: 12 months
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
1 secondary outcome
Patient Health Questionnaire (PHQ)
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Center for Neuroscience and Regenerative MedicineLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Enhancement Training via Smart Phone and Daily Text Messages in people with Subthreshold PTSD, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL) (time frame: change from baseline at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.