Mechanistic Interventions and Neuroscience of Dissociation
ConditionDissociation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Vibration
DeviceParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
350 Participants
are divided into 4 treatment groupsGroup A: Breath FocusExperimental treatment 1 intervention
Group B: VibrationExperimental treatment 1 intervention
Group C: Vibration With Breath FocusExperimental treatment 2 interventions
Group D: Screens FreeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS) Score
The CAPS is a 30-item structured interview that can be used to make current and lifetime diagnosis of post traumatic stress disorder (PTSD) as well as assess PTSD symptoms over the past week. Questions also examine the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The identification of an index traumatic event to serves as the basis for symptom inquiry. The full interview takes approximately 45-60 minutes to administer. Items are scored from 0 to 4 where 0 = the symptom is absent and 4 = the symptom is incapacitating. A symptom severity score is obtained by summing items 1-20. Total scores range from 0 to 80 and a higher score indicates more severe PTSD symptoms.
Time frame
Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention2
Change in Mini International Neuropsychiatric Interview (MINI) Diagnosis of Psychiatric Disorders
The Mini International Neuropsychiatric Interview (MINI) is a semi-structured interview used for diagnosing psychiatric disorders. The number of participants diagnosed with psychiatric disorders at the study time points will be compared between study arms.
Time frame
Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention3
Change in Multiscale Dissociation Inventory (MDI) Score
The MDI is a 30-item self-report test of dissociative symptomology and measures six different types of dissociative responses: disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, and identity dissociation. Items are scored on a 5-point scale where 1 = never and 5 = very often. Total dissociation scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.
Time frame
Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention4
Change in Kentucky Mindfulness Scale (KIMS) Score
The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.
Time frame
Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov