Meditation in Veterans With PTSD and Mild TBI
Condition: Stress Disorders, Post-Traumatic; Concussion, Mild
MeSH terms: Brain Concussion; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Inner Resources for Veterans (IRV); Essential Skills therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress Disorders, Post-Traumatic; Concussion, Mild; Brain Injuries; Community Integration; Meditation; Magnetic Resonance Imaging