Meditation in Veterans With PTSD and Mild TBI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02280304|
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Concussion, Mild||Behavioral: Inner Resources for Veterans (IRV) Behavioral: Essential Skills therapy||Not Applicable|
Approximately 18-22% of Operation Enduring Freedom/Operation Iraqi Freedom/ Operation New Dawn (OEF/OIF/OND) Veterans have been diagnosed with posttraumatic stress disorder (PTSD), and 15-30% of Veterans report mild traumatic brain injury (mTBI). The effects of mTBI and PTSD have been evident since military personnel first came home and continue to be difficult to eradicate. At 3-4 months post-deployment, OIF Veterans with mild TBI were more likely to endorse PTSD symptoms than those without mTBI. The co-morbidity may be long-lasting, or at least recurrent, as TBI-related symptoms were strongly associated with traumatic stress five years after injury. In an examination of factors associated with postconcussive symptoms, PTSD was a strong factor. In active duty marines, mTBI during deployment predicted PTSD after deployment, and in a study of OEF-OIF-OND Veterans, 57.3% of those with mTBI had PTSD.
The literature on how mTBI and co-morbid PTSD affect each other and the effects on Veterans several years post-deployment is sparse. Treatment recommendations specific to Veterans with both mTBI and PTSD are in flux, and while treatments address each disorder independently, they may not be effective when the two disorders co-occur. Further impacting successful treatment of Veterans is the fact that many Veterans do not seek treatment, in part due to the distance they travel to obtain VA services and stigma.
Treatments that are accessible and improve symptoms in patients with mTBI and PTSD alone may facilitate rehabilitation in Veterans with co-morbid mTBI and PTSD. Mindfulness and mantra have been suggested to be effective in Veterans with PTSD and in civilians with TBI, improving quality of life. The current study proposes a type of mindfulness targeted for Veterans, Inner Resources for Veterans (IRV).
Inner Resources for Veterans (IRV), a mindfulness and mantra intervention, is based on Inner Resources for Stress, an intervention which utilizes mindfulness, techniques that encourage present moment attention for the purpose of promoting better self-monitoring and self-regulation, and mantra, the repetition of sounds that do not have meaning in order to maintain present focused attention. The Inner Resources protocol targets PTSD and has been associated with reduced PTSD and anxiety symptoms, reduced number of depressive symptoms, and depression remissions at a 9-month follow-up, as well as increased perceived self-efficacy. Pilot results of older combat Veterans with PTSD indicated that Inner Resources is a safe, feasible, and acceptable intervention. The control condition is an active treatment called Essential Skills, a manualized therapy adapted from a similar therapy utilized at multiple VAs as a psychoeducational and symptom management treatment for PTSD. In a previous study at the Michael E. DeBakey VA that did not investigate the effect of mTBI, Essential Skills provided education on the symptoms and effects of PTSD. For example, subjects learned to recognize the circumstances that triggered their symptoms, how to identify and participate in healthy activities, and how to monitor their sleep. In the current study, in Essential Skills, Veterans learn about symptoms of both mTBI and PTSD and coping skills.
In addition to the changes in functional and psychological symptoms and neural pathways, IRV would offer Veterans a treatment they could utilize whenever challenging situations occur regardless of location. Since the treatment would be relatively cost-free after initial training, IRV could also dramatically reduce financial burden to both Veterans and VA. Few treatment studies focusing on Veterans with co-morbid mTBI and PTSD support the innovation of this study, as does generation of community integration data to relate to changes in functional connectivity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neuroimaging Meditation Therapy in Veterans With Co-Morbid TBI and PTSD|
|Actual Study Start Date :||November 3, 2014|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||March 26, 2018|
Experimental: Inner Resources for Veterans (IRV) mindfulness and mantra
Complete a mindfulness and mantra therapy
Behavioral: Inner Resources for Veterans (IRV)
Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation
Active Comparator: Essential Skills therapy
Learn symptoms of mTBI and PTSD, coping skills
Behavioral: Essential Skills therapy
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.
- Clinician-Administered PTSD Scale (CAPS5) [ Time Frame: 12 weeks ]Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.
- Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control [ Time Frame: 12 weeks and baseline ]Functional connectivity was measured between the Default Mode Network (DMN) and lateral prefrontal cortex (LPFC), and between the amygdala and anterior cingulate. There were four seeds for the DMN (MPFC, PCC, left lateral parietal, right lateral parietal), and two seeds for the amygdala (right and left). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
- Community Reintegration in Service Members (CRIS) [ Time Frame: 12 weeks and baseline ]Scores at baseline and 12 weeks in responses to the computerized version of the Community Reintegration in Service Members (CRIS-CAT) questionnaire in patients following meditation or control. There are three subscales: Extent of Participation (range 24-90), Perceived Limitations (range 33-99), and Satisfaction (range 34-91). Higher is better.
- PTSD Checklist 5 (PCL5) Difference Score [ Time Frame: 12 weeks, baseline ]The PTSD Checklist 5 (PCL5) is a measure of PTSD symptoms based on DSM-V. The scores fall in the range 0-80; higher scores indicate worse outcome. We calculated the PTSD Checklist 5 (PCL5) difference score by subtracting the value at baseline minus the value at week 12. In this case higher scores represent a reduction in PTSD symptoms.
- Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score [ Time Frame: 12 weeks, baseline ]The Patient Health Questionnaire-9 (PHQ-9) measure is a self-report measure of depression symptoms. Scores fall in the range 0-27; higher scores indicate worse outcome. This difference score denotes improvement in symptoms of depression. It was calculated by subtracting the value of PHQ-9 scores at baseline minus PHQ-9 scores scores at week 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280304
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mary R Newsome, PhD||Michael E. DeBakey VA Medical Center, Houston, TX|