CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Inner Resources for Veterans (IRV) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02280304
NCT02280304N/ACompleted

Neuroimaging Meditation Therapy in Veterans With Co-Morbid TBI and PTSD

VA Office of Research and Development·interventional·Posted Oct 31, 2014·Updated Mar 9, 2020

In Brief

A clinical study evaluating Inner Resources for Veterans (IRV) and Essential Skills therapy for Stress Disorders, Post-Traumatic and Concussion, Mild. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 31, 2014
Enrollment StartNov 3, 2014
Primary CompletionJun 30, 2017
Study CompletionMar 26, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.7 years ago

Interventions

Inner Resources for Veterans (IRV)behavioral

Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation

Essential Skills therapybehavioral

This active comparator is adapted from a therapy utilized at multiple VAs as a psychoeducational AND symptom management treatment for PTSD. In it, participants learn about mTBI and PTSD symptoms and coping information for PTSD.