Mechanistic Interventions and Neuroscience of Dissociation

NCT04670640, Not applicable, Recruiting, Emory University

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Mechanistic Interventions and Neuroscience of Dissociation	ClinicalTrials.gov
NCT number	NCT04670640	ClinicalTrials.gov
Status	Recruiting	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	350 participants, estimated	ClinicalTrials.gov
Lead sponsor	Emory University	ClinicalTrials.gov
Conditions	Dissociation	ClinicalTrials.gov
Interventions	Vibration, Breath Focus, No Distractions	ClinicalTrials.gov
First posted	2020-12-17	ClinicalTrials.gov
Last updated	2026-04-20	ClinicalTrials.gov

Registered outcomes 47

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Change in Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	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.	ClinicalTrials.gov
Primary	Change in Mini International Neuropsychiatric Interview (MINI) Diagnosis of Psychiatric Disorders	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	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.	ClinicalTrials.gov
Primary	Change in Multiscale Dissociation Inventory (MDI) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	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.	ClinicalTrials.gov
Primary	Change in Kentucky Mindfulness Scale (KIMS) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	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.	ClinicalTrials.gov
Primary	Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.	ClinicalTrials.gov
Primary	Change in Attentional Control Scale (ACS) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.	ClinicalTrials.gov
Primary	Change in Difficulties in Emotion Regulation Scale (DERS) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.	ClinicalTrials.gov
Primary	Change in PTSD Symptom Checklist (PCL-5) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The PCL-5 is a 20-item self-report measure that assess the DSM-V symptoms of PTSD. Responses are given on a scale from 0 to 4 where 0 = not at all and 4 = extremely. Total scores range from 0 to 80 where higher scores indicate increased symptoms of PTSD.	ClinicalTrials.gov
Primary	Change in Change in Life Events Checklist Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The Life Events Checklist includes 21 items asking respondents if they have been exposed to stressful events in the last 3 to 4 weeks. Participants are also able to list stressful events or experiences that are not specifically listed. Responses are coded as 5 = happened to me, 4 = witnessed it, 3 = learned about it, 2 = part of my job, 1 = not sure, and 0 = does not apply. A total score or composite score is not calculated for the Life Events Checklist, rather this instrument is used to identify if the respondent has experienced traumatic situations.	ClinicalTrials.gov
Primary	Change in Sense of Agency Rating Scale (SOARS) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The SOARS is a 10-item self-report measure that assess the sense of control one has over their body. Responses are given on a 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 10 to 70 where lower scores indicate greater sense of agency.	ClinicalTrials.gov
Primary	Change in Primary Care PTSD Screen (PC-PTSD-5) Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The PC-PTSD-5 is a 5-item instrument is used to identify persons with probable PTSD. Participants reporting that they have experienced a traumatic event are asked if they have had certain symptoms of PTSD in the past month. Responses are scored as no = 0 and yes = 1. Total scores range from 0 to 5 with higher scores indicating increased symptoms of PTSD.	ClinicalTrials.gov
Primary	Change in Scale of Body Connection (SBC) Body Awareness Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The Scale of Body Connection instrument has 20 items assessing the dimensions of Body Awareness and Bodily Dissociation. Items are scored on a 5-point scale where 0 = not at all and 4 = all of the time. The body awareness dimension has 12 items and the body awareness score is the average of responses to these items. Higher scores indicate greater bodily awareness.	ClinicalTrials.gov
Primary	Change in Scale of Body Connection (SBC) Bodily Dissociation Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The Scale of Body Connection instrument has 20 items assessing the dimensions of Body Awareness and Bodily Dissociation. Items are scored on a 5-point scale where 0 = not at all and 4 = all of the time. The bodily dissociation dimension has 8 items and the bodily dissociation score is the average of responses to these items. Higher scores indicate greater bodily dissociation.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses lifetime alcohol use with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater lifetime use of alcohol.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol 30 Day Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses alcohol use in the last 30 days with up to 4 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater use of alcohol in the past 30 days.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco Lifetime Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses lifetime tobacco use with up to 8 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater lifetime use of tobacco.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco 30 Day Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses tobacco use in the last 30 days with up to 5 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater use of tobacco in the past 30 days.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine Lifetime Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses lifetime cocaine use with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 16 where higher scores indicate greater lifetime use of cocaine.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine 30 Day Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses cocaine use in the last 30 days with up to 4 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater use of cocaine in the past 30 days.	ClinicalTrials.gov
Primary	Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin Lifetime Score	Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention	The KMSK assesses lifetime heroin use with up to 8 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 13 where higher scores indicate greater lifetime use of heroin.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Numerical Stroop Task	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition

Source 4

Field	Value	Source
Release	trials-2026-11-12-0.3.0	ClinicalTrials.gov
Release manifest SHA-256	4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.3.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.