Physiological Augmentation of Mindfulness Meditation (PAMM)

September 20, 2022 updated by: Negar Fani, Emory University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30329
        • Wesley Woods Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Breath-Focused Meditation
Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation.
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".
EXPERIMENTAL: Breath-Focused Meditation + Physiological Feedback
Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multiscale Dissociation Inventory (MDI) Score
Time Frame: 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.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Modified PTSD Symptom Scale (MPSS) Score
Time Frame: 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.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Kentucky Mindfulness Scale Score
Time Frame: 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.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Multidimensional Assessment of Interoceptive Awareness Score
Time Frame: 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.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Clinician Administered PTSD Scale (CAPS) Score
Time Frame: Baseline
The CAPS is a 30-item structured interview that can be used to make current and lifetime diagnosis of post traumatic stress disorder (PTSD) as well as assess PTSD symptoms over the past week. Questions also examine the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The identification of an index traumatic event to serves as the basis for symptom inquiry. The full interview takes approximately 45-60 minutes to administer. Items are scored from 0 to 4 where 0 = the symptom is absent and 4 = the symptom is incapacitating. A symptom severity score is obtained by summing items 1-20. Total scores range from 0 to 80 and a higher score indicates more severe PTSD symptoms.
Baseline
Change in Mini International Neuropsychiatric Interview (MINI) Score
Time Frame: Baseline
Mini International Neuropsychiatric Interview is a semistructured interview that will be used to assess for concurrent mood, substance, and psychotic disorders. The interview takes 30 minutes - 1 hour to administer. Participants answer "yes" or "no" to questions about symptoms they have been having; from these responses a clinician can diagnose lifetime and/or current presence of 22 psychiatric conditions. The number of instrument items used per interview depends on responses to previous questions and the interview is not designed to provide a numeric total score.
Baseline
Change in Kreek-McHugh-Schluger-Kellogg (KMSK) Marijuana/Cannabis Scale Score
Time Frame: Baseline
This is a clinical measure designed to quickly assess the nature and extent of recreational use of cannabis during the last 24 hours. The instrument includes a 15-item scale where respondents indicate how much the agree with reasons for using marijuana, where 0 = strongly disagree and 5 = strongly agree. The full measure will be administered at the beginning of study participation, and one question about drug use in the past day (if applicable) will be administered on study intervention days.
Baseline
Change in Affective Number Stroop (ANS) Task Score
Time Frame: Up to Week 4
During the Affective Number Stroop (ANS) Task, participants are instructed to rapidly identify the number of numbers in a given display while ignoring evocative distractor images (trauma-relevant scenes) while in a MRI scanner. In these trials, the number of numbers presented is either consistent or inconsistent with the actual number displayed, such that there are both congruent and incongruent trials. The participants will be presented with positive and neutral pictures in addition to the negative trauma-relevant images. The task will be completed in the MRI scanner during both the pre- and post-treatment sessions.
Up to Week 4
Change in Penn Computerized Neuropsychological Battery Performance
Time Frame: Up to Week 4
This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery will be administered, which take approximately 30 minutes to complete.
Up to Week 4
Change in Posttraumatic Avoidance Behaviour Questionnaire (PABQ) Score
Time Frame: Week 4 (post-treatment), Week 8 (one month post-treatment)
The PABQ includes 25 items asking participants how often they engaged in certain behaviors in the past 3 weeks. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 25 to 100 and higher scores indicate greater avoidance. This questionnaire will be given at post-treatment and follow-up time points to capture participants' avoidance behaviors during this time.
Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in Chesney's Coping Self-Efficacy Scale (CSES) Score
Time Frame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in State Self Efficacy Scale Score
Time Frame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
This is a 7 Item measure using a 7-point likert scale that will examine changes over time in self-efficacy on a state level. Responses to items range from 1 = strongly disagree to 7 = strongly agree. Total scores range from 1 to 49 where higher scores indicate greater self-efficacy.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in Moral Injury Events Scale for Civilians (MIES-C) Score
Time Frame: Baseline
The Moral Injury Events Scale for Civilians (MIES-C) measurement is a 10-item scale assessing for the presence of potentially morally injurious events and feelings of distress that can emerge in the aftermath of these events. Responses are given on a 6-point scale where 1 = strongly agree and 6 = strongly disagree. Total scores range from 10 to 60 and lower scores indicate more exposure to events that conflict with the respondents sense of right and wrong.
Baseline
Change in Attentional Control Scale (ACS) Score
Time Frame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in State Trait Anxiety Inventory (STAI) Score
Time Frame: Baseline up to Week 4 (post-treatment)
The STAI is a 40-item self-report measure that uses a 4-point Likert scale to evaluate both state and trait anxiety. Total scores range from 40 to 160 and items are scored so that a higher total score indicates greater symptoms of anxiety. This is administered at the pre-MRI and post-MRI data collection points for every MRI visit.
Baseline up to Week 4 (post-treatment)
Change in Visual Analogue Scale (VAS) Score
Time Frame: Baseline, Week 4 (post-treatment)
This is a 6-item self-report measure that indicates how intense one is feeling certain emotions using a 10-point Likert scale. Total scores range from 0 to 60 with higher scores indicating greater intensity of emotions.
Baseline, Week 4 (post-treatment)
Change in Motivation and Pleasure -Self Report (MAP-SR) Score
Time Frame: Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
The MAP-SR is an 18-item self-report measure that assesses the motivation and pleasure domain of negative symptoms. Items are rated on a 5-point Likert scale and total scores range from 0 to 72. Certain items are reverse scored so that lower scores indicate greater pathology.
Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)
Change in State Mindfulness Scale (SMS) Score
Time Frame: Pre-intervention and post-intervention of each session up to Week 4
This is a 21-item self-report measure that uses a 5-point Likert scale to assess one's perceived level of awareness and attention to the present moment and environment within a given frame of time (i.e. the last 10 minutes). This is administered before and after each intervention session. Responses are given on a scale from 1 (not at all) to 5 (very well). Total scores range from 21 to 105 and higher scores indicate greater mindfulness.
Pre-intervention and post-intervention of each session up to Week 4
Client Satisfaction Questionnaire (CSQ)
Time Frame: Week 4 (post-treatment)
The CSQ is an 11-item self-report measure to assess how the intervention satisfied the participant's expectations and/or if it helped their daily lives in any way. The questionnaire contains a mix of scaled responses and open ended questions and there is not a summary score for this measurement.
Week 4 (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00085711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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