Physiological Augmentation of Mindfulness Meditation

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Other: Breath-Focused Meditation; Device: Physiological Feedback

• Registration Number: NCT02754557
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Status Verified: 2022-09
• Results First Submitted: 2022-09-20
• Results First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Results First Posted: 2022-10-17
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

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Exclusion Criteria

• Actively psychotic
• Cognitively compromised
• Pregnancy
• Substance or Alcohol Dependence

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breath-Focused Meditation	Breath-Focused Meditation	Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation.
Breath-Focused Meditation + Physiological Feedback	Physiological Feedback	Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.
Breath-Focused Meditation + Physiological Feedback	Breath-Focused Meditation	Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.

Primary Outcome Measures

Name	Time	Method
Multiscale Dissociation Inventory (MDI) Score	Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)	The MDI is a 30-item self-report test of dissociative symptomology and it measures six different types of dissociative response. The scales of the MDI are disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, identity dissociation, and total dissociation. Items are scored from 1 to 5 where 1 = never and 5 = very often. Total scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.
Modified PTSD Symptom Scale (MPSS) Score	Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)	The MPSS is an 18-item instrument assessing the presence and severity of PTSD symptoms related to specific traumatic events in individuals with a known trauma history. Respondents indicate how frequently they experience each item on a scale of 0 to 3 where 0 = not at all and 3 = almost always. PTSD symptomatology over the prior 2 weeks is assessed, yielding a continuous measure of PTSD symptom severity ranging from 0 to 54. A higher score indicates greater symptom severity.
Kentucky Mindfulness Scale Score	Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)	The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.
Multidimensional Assessment of Interoceptive Awareness Score	Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)	This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.

Trial Locations

Locations (2)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Wesley Woods Center; 🇺🇸 Atlanta, Georgia, United States