Meditation in Veterans With PTSD and Mild TBI

Completed · Not applicable

Conditions studied: Stress Disorders, Post-Traumatic, Concussion, Mild

In brief

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.

Key facts

Study ID

NCT02280304

Run by

VA Office of Research and Development

People needed

46

Starts

2014-11-03

Expected to finish

2018-03-26

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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