Physiological Augmentation of Mindfulness Meditation

NCT ID: NCT02754557

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2021-09-21

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breath-Focused Meditation

Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation.

Group Type: EXPERIMENTAL

Breath-Focused Meditation

Intervention Type: OTHER

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".

Breath-Focused Meditation + Physiological Feedback

Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.

Group Type: EXPERIMENTAL

Breath-Focused Meditation

Intervention Type: OTHER

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".

Physiological Feedback

Intervention Type: DEVICE

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.

Interventions

Breath-Focused Meditation

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".

Intervention Type: OTHER

Physiological Feedback

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Negar Fani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Negar Fani, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Wesley Woods Center

Atlanta, Georgia, United States

Countries

United States

References

Powers A, Dixon HD, Guelfo A, Mekawi Y, Bradley B, Kaslow N, Fani N. The mediating role of emotion dysregulation in the association between trait mindfulness and PTSD symptoms among trauma-exposed adults. Mindfulness (N Y). 2021 Sep;12(9):2229-2240. doi: 10.1007/s12671-021-01684-8. Epub 2021 Jul 16.

Reference Type: DERIVED

PMID: 34603539 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00085711

Identifier Type: -

Identifier Source: org_study_id