Physiological Augmentation of Mindfulness Meditation

NCT02754557 | Completed Results FDA Device

• 1 other identifier: IRB00085711
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Trauma; PTSD; Mindfulness; Meditation; Neuroimaging; MRI

Outcome Measures

Primary Outcomes (4)

• Multiscale Dissociation Inventory (MDI) Score

  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.

  Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)

• Modified PTSD Symptom Scale (MPSS) Score

  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.

  Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)

• Kentucky Mindfulness Scale Score

  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.

  Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)

• Multidimensional Assessment of Interoceptive Awareness Score

  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.

  Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)

Other Outcomes (16)

• Change in Clinician Administered PTSD Scale (CAPS) Score

  Baseline

• Change in Mini International Neuropsychiatric Interview (MINI) Score

  Baseline

• Change in Kreek-McHugh-Schluger-Kellogg (KMSK) Marijuana/Cannabis Scale Score

  Baseline

Study Arms (2)

Breath-Focused Meditation

EXPERIMENTAL

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

Other: Breath-Focused Meditation

Breath-Focused Meditation + Physiological Feedback

EXPERIMENTAL

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

Other: Breath-Focused Meditation; Device: Physiological Feedback

Interventions

Breath-Focused Meditation 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; Breath-Focused Meditation + Physiological Feedback

Physiological Feedback 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.

Breath-Focused Meditation + Physiological Feedback

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• University of Pittsburgh: collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Wesley Woods Center

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• 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.

  PMID: 34603539 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Negar Fani, PhD
• Organization: Emory University

nfani@emory.edu

404-712-0354

Study Officials

• Negar Fani, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 28, 2016
• Study Start: March 1, 2016
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: October 17, 2022
• Results First Posted: October 17, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)