What this study is
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.
What's being tested
- Vibration
Intervention · DEVICE
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
Intervention · BEHAVIORAL
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
Intervention · BEHAVIORAL
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.
Study details
- Sponsor
- Emory University
- Conditions
- Dissociation
- Enrolling
- 350 people
- Starts
- 2021-09-18
- Est. completion
- 2027-03
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openGrady Hospital
Atlanta, Georgia, United States
- Negar Fani, PhD · Principal investigator
RecruitingWestern Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Completed
Study team
Sponsor
Emory University
Study ID STUDY00001840
Principal investigator
Negar Fani, PhD
Emory University
Principal investigator
Greg Siegle, PhD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.