Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Neuroimaging Meditation Therapy in Veterans With Co-Morbid TBI and PTSD
Verified date | February 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | March 26, 2018 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Mild traumatic brain injury (mTBI) as defined by the VA/DoD Clinical Practice Guideline. - PTSD as assessed by the Clinician Administered PTSD Scale (CAPS); - Aged 18 - 49; - Have not previously participated in meditation training. Exclusion Criteria: The investigators will exclude subjects who: - Meet DSM-IV criteria for drug or alcohol abuse in past 30 days; - Have a history of severe TBI based on any of following: - Glasgow Coma Score < 8; - alteration of consciousness greater than 24 hours; loss of consciousness greater than 30 minutes; - Have current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but not limited to: - epilepsy, - Parkinson's disease, - Huntington's disease, - Alzheimer's disease, - stroke, - chemotherapy for cancer; - Have acute psychological instability as assessed by MEDVAMC clinician or study staff or concurrent diagnosis or schizophrenia, schizoaffective disorder, delusional disorder, organic psychosis, and subjects taking antipsychotic medication, and - Have already completed a course of meditation training. - The investigators will also exclude participants with general contraindications for MRI, including metal in or around the head (e.g., orthodontia, non-removable body piercings, etc.), ferromagnetic material in the body (e.g., non-removable body piercings), or non-MRI compatible medical devices. |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Palo Alto University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PTSD Checklist 5 (PCL5) Difference Score | 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. | 12 weeks, baseline | |
Other | Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score | 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. | 12 weeks, baseline | |
Primary | Clinician-Administered PTSD Scale (CAPS5) | Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control. | 12 weeks | |
Secondary | Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control | 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. | 12 weeks and baseline | |
Secondary | Community Reintegration in Service Members (CRIS) | 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. | 12 weeks and baseline |
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