N/A
N=65
Physiological Augmentation of Mindfulness Meditation
Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02754557 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Multiscale Dissociation Inventory (MDI) Score — 53.19; 61.58; 47.15; 51.00 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breath-Focused Meditation (Other); Physiological Feedback (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multiscale Dissociation Inventory (MDI) Score |
53.19; 61.58; 47.15; 51.00; 44.11; 47.94 | — |
| PRIMARY Modified PTSD Symptom Scale (MPSS) Score |
27.33; 28.82; 19.63; 20.97; 17.58; 19.44 | — |
| PRIMARY Kentucky Mindfulness Scale Score |
122.19; 117.55; 125.37; 125.79; 124.58; 126.65 | — |
| PRIMARY Multidimensional Assessment of Interoceptive Awareness Score |
98.22; 86.45; 107.37; 106.92; 110.63; 105.29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02754557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.