MedTrace Logo

Physiological Augmentation of Mindfulness Meditation

NCT02754557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-10-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

OTHER

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".

DEVICE

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.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Negar Fani, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-09-21
Completion
2021-09-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02754557 on ClinicalTrials.gov