Physiological Augmentation of Mindfulness Meditation
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy of a physiologically-augmented
      breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are
      associated with psychological trauma, as well as symptoms of posttraumatic stress disorder
      (PTSD). The study will evaluate whether physiological augmentation produces a greater change
      in dissociative symptoms, meditative engagement and attentional control, compared to
      non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a
      vibration on the wrist. Vibrations are delivered by a device that will be placed on a
      participant's arm; the device vibrates in proportion to the person's breath.
    

Detailed description: 
      Chronically traumatized people are at much higher risk for developing dissociative symptoms,
      which are notoriously difficult to treat, particularly in the context of other posttraumatic
      stress disorder symptoms. Dissociation is a phenomenon that involves feelings of separation
      from one's body and emotional state. Mindfulness practices, including breath-focused
      mindfulness meditation, are known to be useful for improving attention to one's physiological
      state, thus enhancing a feeling of "connection" with one's present experience. However,
      mindfulness-based practices are naturally a challenging task for highly dissociative people.
      The present project proposes the use of a novel device that uses physiological feedback to
      boost the effects of breath-focused mindfulness meditation in this population. This device is
      an element placed on the wrist that vibrates in accordance with one's breath. The method
      capitalizes on a "bottom-up" neurophysiological process. This study plans to recruit 80
      highly dissociative traumatized African American women through an established and highly
      productive NIH-funded project. Participants will be randomly assigned to 6 sessions of either
      breath-focused mindfulness meditation or physiologically augmented breath-focused mindfulness
      meditation. Electroencephalography data will be collected during the intervention sessions,
      and functional magnetic resonance imaging data will be collected pre- and post-intervention.
      These methods will be used to assess whether the physiological augmentation is producing:
      increased coherence or "network-like" activity among brain regions involved with
      interoception (awareness of one's bodily state); selective attention to the breath (increased
      temporo-parietal EEG gamma) and meditative engagement (increased frontal EEG theta). Clinical
      and neuropsychological measures will be used to assess potential effects on dissociative and
      posttraumatic symptoms, as well as selective and sustained attention and mindfulness ability.
      A follow-up will be conducted 1 month post-treatment to examine sustained clinical and
      cognitive effects.
    

Intervention name(s): Breath-Focused Meditation; Physiological Feedback
Intervention type(s): Other; Device
Intervention description(s): Participants will attend two breath-focused meditation sessions per week for three weeks. During the breath focus task, participants are asked to alternatively focus their breathing (1.5 minutes of breathing and 15 seconds of rest). Participants will be asked to "attend to the changing patterns of physical sensations as the breath moves in and out of your body. Focus your awareness on any sensations you may experience (e.g., your abdominal wall rising). Follow the sensations as you breathe in and all the way through until your breath leaves your body".; Participants will receive breath feedback, via dynamic velocity estimates from a respiration belt, which allows an analog of breath to be felt as vibration on their wrist via a tactile transducer on a table. The transducer is tuned to produce low frequencies so there is more vibration and less of an audible component than a regular speaker would produce.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trauma; PTSD; Mindfulness; Meditation; Neuroimaging; MRI