Mechanistic Interventions and Neuroscience of Dissociation (MIND)

Emory University

Status: Enrolling

Conditions: Dissociation

Treatments: Behavioral: Breath Focus; Behavioral: No Distractions; Device: Vibration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04670640

R01AT011267-01 (U.S. NIH Grant/Contract)

STUDY00001840

Details and patient eligibility

About

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.

Full description

People exposed to chronic trauma face devastating effects to the brain and body. Chronically traumatized people become highly distressed when attending to emotional stimuli, which can lead to feelings of detachment from their bodies and environment. It is difficult to engage highly dissociative traumatized patients in trauma-focused treatment; however, these patients benefit from acquiring basic emotion regulation skills, including present-centeredness and body awareness. Various practices that involve present-centeredness and body awareness (including mindfulness-based interventions) have been shown to demonstrate short-term and long-term improvement in cognition, emotion regulation and clinical symptoms in dissociative people with trauma exposure.

In order to address this issue, the researchers will evaluate the effectiveness of interventions that engage present-centered awareness and/or body focus.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 4 patient groups

Breath Focus

Experimental group

Description:

Participants receiving the breath focus study intervention.

Treatment:

Behavioral: Breath Focus

Vibration

Experimental group

Description:

Participants receiving the vibration study intervention.

Treatment:

Device: Vibration

Vibration With Breath Focus

Experimental group

Description:

Participants receiving the vibration with breath focus study intervention.

Treatment:

Device: Vibration

Behavioral: Breath Focus

Screens Free

Experimental group

Description:

Participants receiving the screens free study intervention.

Treatment:

Behavioral: No Distractions