Clinical trial NCT04670640: Mechanistic Interventions and Neuroscience of Dissociation
Official title: Mechanistic Interventions and Neuroscience of Dissociation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dissociation
Keywords: Trauma
PTSD
Mindfulness
Meditation
Neuroimaging
MRI
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-12-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Mini International Neuropsychiatric Interview (MINI) Diagnosis of Psychiatric Disorders
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Multiscale Dissociation Inventory (MDI) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kentucky Mindfulness Scale (KIMS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Attentional Control Scale (ACS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in PTSD Symptom Checklist (PCL-5) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Change in Life Events Checklist Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Sense of Agency Rating Scale (SOARS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Primary Care PTSD Screen (PC-PTSD-5) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Scale of Body Connection (SBC) Body Awareness Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Scale of Body Connection (SBC) Bodily Dissociation Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiate Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiates 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates Lifetime Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates 30 Day Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-D) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in International Trauma Questionnaire Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Childhood Trauma Questionnaire (CTQ) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Motivation and Pleasure Scale Self-Report (MAP-SR) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Ruminative Responses Scale Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Everyday Discrimination Scale (EDS) Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Experiences of Discrimination (EOD) Scale Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Epworth Sleepiness Scale Score
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Penn Computerized Neuropsychological Battery (Penn CNP) Performance
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in State Scale of Dissociation (SSD) Score
timeFrame: Baseline to Week 6 (before and after each study visit)
measure: Change in Affective Number Stroop (ANS) Task Performance
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Stroop Color and Word Test (SCWT) Time
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Number Stroop Test Time
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
measure: Change in Pittsburgh EEG Accessible Calibration Environment (PEACE) Performance
timeFrame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Negar Fani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Greg Siegle, PhD
role: PRINCIPAL_INVESTIGATOR
References: