Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-01 @ 4:16 PM
Study NCT ID:
NCT02754557
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physiological Augmentation of Mindfulness Meditation
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Physiological Augmentation of Mindfulness Meditation
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMM
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: