Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT04670640

Conditions

Dissociation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Vibration

Breath Focus

No Distractions

Study Details

Brief summary:

The purpose of this study is to test the neurophysiological mechanisms of an intervention to reduce symptoms of dissociation in traumatized people. The intervention will be tested in dissociative traumatized people at two sites: Emory University and University of Pittsburgh. The researchers are interested in whether neural networks associated with attentional control and interoceptive awareness can be enhanced in this population. The researchers propose to evaluate whether different body-focused and non-body focused interventions can change these mechanisms.

Conditions

Dissociation

Study ID

NCT04670640

Start date

Sep 18, 2021

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • experience of at least one Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criterion A trauma (assessed using the Life Events Checklist)
  • a score of 7 or higher on the Multiscale Dissociation Inventory (MDI) depersonalization subscale
  • willingness to participate in the study

Exclusion Criteria:

  • actively psychotic and cognitively compromised individuals (assessed using the Moderate-severe cognitive impairment screening tool (MoCA) will be excluded
  • moderate or more severe substance dependence (assessed with the MINI)
  • persons with imminent risk of physical violence to self or others

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Breath Focus

Participants receiving the breath focus study intervention.

experimental: Vibration

Participants receiving the vibration study intervention.

experimental: Vibration With Breath Focus

Participants receiving the vibration with breath focus study intervention.

experimental: Screens Free

Participants receiving the screens free study intervention.

Interventions

Vibration

Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. There will be no explicit tasks or direction given in this intervention. Participants will experience smooth slowly varying breath-like vibration on their sternum. They will receive their assigned intervention for approximately 18 minutes.

Breath Focus

Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. The participant will be asked to focus on their breathing during this intervention. They will receive their assigned intervention for approximately 18 minutes.

No Distractions

Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. Participants will engage in a period of no-screen time; during this time there will be no outside visual or auditory distractions. There will be no explicit tasks or direction given in this intervention. They will receive their assigned intervention for approximately 18 minutes.

Primary outcome measure

  • Change in Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Mini International Neuropsychiatric Interview (MINI) Diagnosis of Psychiatric Disorders [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Multiscale Dissociation Inventory (MDI) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kentucky Mindfulness Scale (KIMS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Attentional Control Scale (ACS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Difficulties in Emotion Regulation Scale (DERS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in PTSD Symptom Checklist (PCL-5) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Change in Life Events Checklist Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Sense of Agency Rating Scale (SOARS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Primary Care PTSD Screen (PC-PTSD-5) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Scale of Body Connection (SBC) Body Awareness Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Scale of Body Connection (SBC) Bodily Dissociation Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiate Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiates 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates Lifetime Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates 30 Day Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-D) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in International Trauma Questionnaire Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Childhood Trauma Questionnaire (CTQ) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Motivation and Pleasure Scale Self-Report (MAP-SR) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Ruminative Responses Scale Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Everyday Discrimination Scale (EDS) Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Experiences of Discrimination (EOD) Scale Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Epworth Sleepiness Scale Score [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Penn Computerized Neuropsychological Battery (Penn CNP) Performance [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in State Scale of Dissociation (SSD) Score [ Time Frame: Baseline to Week 6 (before and after each study visit) ]
  • Change in Affective Number Stroop (ANS) Task Performance [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Stroop Color and Word Test (SCWT) Time [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Number Stroop Test Time [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]
  • Change in Pittsburgh EEG Accessible Calibration Environment (PEACE) Performance [ Time Frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention ]

Central Contacts and Locations

Central contacts

Negar Fani, PhD

404-712-0354nfani@emory.edu

Greg Siegle, PhD

412-864-3501gsiegle@pitt.edu

Locations

Grady Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Negar Fani, PhD

More Information

Sponsor

Emory University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Trauma
  • PTSD
  • Mindfulness
  • Meditation
  • Neuroimaging
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-20.