Clinical trial NCT02754557: Physiological Augmentation of Mindfulness Meditation
Official title: Physiological Augmentation of Mindfulness Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Trauma
PTSD
Mindfulness
Meditation
Neuroimaging
MRI
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2016-04-28
Enrollment: 65
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Multiscale Dissociation Inventory (MDI) Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Modified PTSD Symptom Scale (MPSS) Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Kentucky Mindfulness Scale Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Multidimensional Assessment of Interoceptive Awareness Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Secondary outcomes:
Other outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) Score
timeFrame: Baseline
measure: Change in Mini International Neuropsychiatric Interview (MINI) Score
timeFrame: Baseline
measure: Change in Kreek-McHugh-Schluger-Kellogg (KMSK) Marijuana/Cannabis Scale Score
timeFrame: Baseline
measure: Change in Affective Number Stroop (ANS) Task Score
timeFrame: Up to Week 4
measure: Change in Penn Computerized Neuropsychological Battery Performance
timeFrame: Up to Week 4
measure: Change in Posttraumatic Avoidance Behaviour Questionnaire (PABQ) Score
timeFrame: Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in Chesney's Coping Self-Efficacy Scale (CSES) Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in State Self Efficacy Scale Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in Moral Injury Events Scale for Civilians (MIES-C) Score
timeFrame: Baseline
measure: Change in Attentional Control Scale (ACS) Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in State Trait Anxiety Inventory (STAI) Score
timeFrame: Baseline up to Week 4 (post-treatment)
measure: Change in Visual Analogue Scale (VAS) Score
timeFrame: Baseline, Week 4 (post-treatment)
measure: Change in Motivation and Pleasure -Self Report (MAP-SR) Score
timeFrame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
measure: Change in State Mindfulness Scale (SMS) Score
timeFrame: Pre-intervention and post-intervention of each session up to Week 4
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Week 4 (post-treatment)
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Wesley Woods Center
state: Georgia
Study officials:
affiliation: Emory University
name: Negar Fani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.