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NCT02280304 · ClinicalTrials.gov registry record · NA
Meditation in Veterans With PTSD and Mild TBI
A NA study of Stress Disorders, Post-Traumatic and Concussion, Mild, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT02280304: Completed NA study of Stress Disorders, Post-Traumatic and Concussion, Mild, sponsored by VA Office of Research and Development.
NCT02280304 is a NA study of Stress Disorders, Post-Traumatic and Concussion, Mild that has completed, run by VA Office of Research and Development. The registered enrollment target is 46 participants, below the 155-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02280304, a NA study of Stress Disorders, Post-Traumatic and Concussion, Mild, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to learn more about how Inner Resources for Veterans (IRV), a mindfulness and mantra therapy, helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more emotionally traumatic experiences. People with PTSD may experience anxiety, pay extra attention to their surroundings, involuntarily remember their traumatic experiences, and/or want to avoid situations where these symptoms are increased. MTBI may result from being in a blast explosion, with pressure from the blast potentially disrupting the brain's structure and function. At this time, it is not well known how PTSD and mTBI may affect each other. In this study, the investigators will be looking at the behavioral and neurological changes (changes in the brain) and the reductions in PTSD symptoms that may come from participating in this treatment. The investigators are interested in determining if treatment does reverse changes in the brain caused by PTSD and mTBI. To help the investigators understand changes in how the brain functions, the participants will complete a functional magnetic resonance imaging (fMRI) scan before and after either IRV or an active control group. Both conditions are 9-session, 12-week interventions. Participation will help the investigators understand how therapy for PTSD and mTBI impacts the brain's response to emotions and therapeutic processes.
Primary Outcome
Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.
Conditions Studied
Interventions
- BEHAVIORAL Inner Resources for Veterans (IRV)
- BEHAVIORAL Essential Skills therapy
Study Locations (1)
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-11-03 |
| Est. Completion | 2018-03-26 |
| Phase | NA |
What the finished NCT02280304 record still lists
NCT02280304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 155-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Stress Disorders, Post-Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Inner Resources for Veterans (IRV) is the first listed.
NCT02280304 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02280304 about?
NCT02280304 is a clinical study titled "Meditation in Veterans With PTSD and Mild TBI". The goal of this study is to learn more about how Inner Resources for Veterans (IRV), a mindfulness and mantra therapy, helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more emotionally traumatic...
What is the current status of trial NCT02280304?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2014-11-03. Estimated completion is 2018-03-26.
What conditions does trial NCT02280304 study?
This clinical trial studies the following conditions: Stress Disorders, Post-Traumatic, Concussion, Mild.
What interventions are being tested in trial NCT02280304?
The interventions under investigation include: Inner Resources for Veterans (IRV) (BEHAVIORAL), Essential Skills therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02280304?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02280304 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02280304's enrollment target sits among peer trials
46 51st of 66 higher than 16 of 66 other Stress Disorders, Post-Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Disorders, Post-Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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