Status:
COMPLETED
Meditation in Veterans With PTSD and Mild TBI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Palo Alto University
Conditions:
Stress Disorders, Post-Traumatic
Concussion, Mild
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief 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 bra...
Detailed Description
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 Veter...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02280304
Start Date
November 3 2014
End Date
March 26 2018
Last Update
March 9 2020
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030