Physiological Augmentation of Mindfulness Meditation (PAMM)

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Emory University

Status

Completed

Conditions

Post Traumatic Stress Disorder

Treatments

Other: Breath-Focused Meditation
Device: Physiological Feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT02754557
IRB00085711

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

Female

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Experience of at least one Criterion A trauma
  • Presence of current symptoms of post traumatic stress disorder (PTSD) that are significantly interfering with functioning
  • Multiscale Dissociation Inventory depersonalization score of 7
  • Fulfill at least two of the Clinician Administered PTSD Subscale criteria of clinically significant re-experiencing, avoidance, alterations in mood and cognitions, hyperarousal
  • Willingness to participate in the study

Exclusion criteria

  • Actively psychotic
  • Cognitively compromised
  • Pregnancy
  • Substance or Alcohol Dependence

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

Breath-Focused Meditation
Experimental group
Description:
Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation.
Treatment:
Other: Breath-Focused Meditation
Breath-Focused Meditation + Physiological Feedback
Experimental group
Description:
Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.
Treatment:
Device: Physiological Feedback
Other: Breath-Focused Meditation

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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