Mechanistic Interventions and Neuroscience of Dissociation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04670640
Status
Recruiting
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Conditions

  • Dissociation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Vibration — 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 — 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 — 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

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.

Key Dates

Start date
Sep 18, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Grady HospitalAtlantaGeorgia30303
Negar Fani, PhD (PRINCIPAL_INVESTIGATOR)
Western Psychiatric Institute and ClinicPittsburghPennsylvania15213-

Find similar trials in Atlanta, GA

By research site
Grady Hospital· Atlanta, GAWestern Psychiatric Institute and Clinic· Pittsburgh, PA

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