CClinicalTrials.gg
RecruitingNCT04670640MINDUpdated Apr 20, 2026

Mechanistic Interventions and Neuroscience of Dissociation

An interventional study of Vibration and Breath Focus in Dissociation, sponsored by Emory University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dissociation

Keywords

  • Trauma
  • PTSD
  • Mindfulness
  • Meditation
  • Neuroimaging
  • MRI
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    Breath Focus

    Participants receiving the breath focus study intervention.

    Behavioral: Breath Focus

  • Experimental
    Vibration

    Participants receiving the vibration study intervention.

    Device: Vibration

  • Experimental
    Vibration With Breath Focus

    Participants receiving the vibration with breath focus study intervention.

    Device: Vibration · Behavioral: Breath Focus

  • Experimental
    Screens Free

    Participants receiving the screens free study intervention.

    Behavioral: No Distractions

Interventions

  • DeviceVibration

    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.

  • BehavioralBreath Focus

    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.

  • BehavioralNo Distractions

    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.

05

What researchers measure

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-intervention

  2. 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-intervention

  3. 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-intervention

  4. 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-intervention

  5. Change in Multidimensional Assessment of Interoceptive Awareness (MAIA) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  6. Change in Attentional Control Scale (ACS) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  7. Change in Difficulties in Emotion Regulation Scale (DERS) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  8. Change in PTSD Symptom Checklist (PCL-5) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  9. Change in Change in Life Events Checklist Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  10. Change in Sense of Agency Rating Scale (SOARS) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  11. Change in Primary Care PTSD Screen (PC-PTSD-5) Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  12. Change in Scale of Body Connection (SBC) Body Awareness Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  13. Change in Scale of Body Connection (SBC) Bodily Dissociation Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  14. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol Lifetime Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  15. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Alcohol 30 Day Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  16. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco Lifetime Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  17. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Tobacco 30 Day Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  18. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine Lifetime Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  19. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Cocaine 30 Day Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  20. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin Lifetime Score

    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.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  21. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Heroin 30 Day Score

    The KMSK assesses heroin 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 13 where higher scores indicate greater use of heroin in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  22. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiate Lifetime Score

    The KMSK assesses lifetime illicit use of prescription opiates with up to 8 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater lifetime illicit use of prescription opiates.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  23. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Opiates 30 Day Score

    The KMSK assesses illicit use of prescription opiates 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 11 where higher scores indicate greater illicit use of prescription opiates in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  24. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis Lifetime Score

    The KMSK assesses lifetime marijuana/cannabis use with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 14 where higher scores indicate greater lifetime use of marijuana/cannabis.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  25. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Marijuana/Cannabis 30 Day Score

    The KMSK assesses marijuana/cannabis 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 marijuana/cannabis in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  26. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine Lifetime Score

    The KMSK assesses lifetime amphetamine/methamphetamine use with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater lifetime use of amphetamine/methamphetamine.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  27. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Amphetamine/Methamphetamine 30 Day Score

    The KMSK assesses marijuana/cannabis 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 11 where higher scores indicate greater use of amphetamine/methamphetamine in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  28. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines Lifetime Score

    The KMSK assesses lifetime illicit use of benzodiazepines with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater lifetime illicit use of benzodiazepines.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  29. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Illicit Benzodiazepines 30 Day Score

    The KMSK assesses illicit use of benzodiazepines 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 11 where higher scores indicate greater illicit use of benzodiazepines in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  30. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines Lifetime Score

    The KMSK assesses lifetime use of healthcare provider prescribed benzodiazepines with up to 7 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater lifetime use of healthcare provider prescribed benzodiazepines.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  31. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Benzodiazepines 30 Day Score

    The KMSK assesses use of healthcare provider prescribed benzodiazepines 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 11 where higher scores indicate greater use of healthcare provider prescribed benzodiazepines in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  32. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates Lifetime Score

    The KMSK assesses lifetime use of barbiturates with up to 8 items. Three of the items are scored quantitatively on varying scales. Total scores range from 0 to 12 where higher scores indicate greater lifetime use of barbiturates.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  33. Change in Kreek-McHugh-Schluger-Kellogg Scale (KMSK) Barbiturates 30 Day Score

    The KMSK assesses use of barbiturates 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 11 where higher scores indicate greater use of barbiturates in the past 30 days.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  34. Change in Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-D) Score

    The PROMIS-D instrument assesses depression with 9 items asking respondents if they have experienced certain symptoms of depression in the past 7 days. Responses are given on a 5-point scale. Total scores are transformed to a t-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate increased depressive symptoms compared to the reference population.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  35. Change in International Trauma Questionnaire Score

    The International Trauma Questionnaire is an instrument used to diagnose PTSD or complex PTSD (CPTSD) with 18 items (9 items for each of the PTSD and CPTSD subscales). Responses are given on a 5-point scale where 0 = not at all and 4 = extremely. Dimensional scores for PTSD and the Disturbances in Self-Organization (DSO) cluster of the CPTSD subscale can be calculated by summing six items from their respective subscales. Total scores for each subscale range from 0 to 24 with higher values indicating increased problems following experiencing a traumatic event.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  36. Change in Childhood Trauma Questionnaire (CTQ) Score

    The Childhood Trauma Questionnaire (CTO) has 28 items asking respondents if they experienced situations of trauma as a child or teenager. Responses are given on a 5-point scale where 1= never true and 5 = always true. There are subscales for sexual abuse, physical abuse, emotional abuse, emotional neglect, and physical neglect, and a total trauma score is calculated. Total scores range from 28 to 140 where higher scores indicate more severe trauma.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  37. Change in Motivation and Pleasure Scale Self-Report (MAP-SR) Score

    The MAP-SR is an 18-item questionnaire assessing the degree of pleasure experienced with social, work or recreational, and family situations and the amount of motivation to engage in activities. Responses are given on a 5-point scale where 0 = no pleasure or no motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 72. Scoring for certain items is reversed so that higher scores indicate increased pleasure and motivation.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  38. Change in Ruminative Responses Scale Score

    The Ruminative Responses Scale is a 22-item instrument assessing different things that people do when they feel depressed. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 22 to 88 and higher scores indicate greater rumination on depressive symptoms, potentially prolonging depressive episodes.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  39. Change in Everyday Discrimination Scale (EDS) Score

    The original Everyday Discrimination Scale includes 9 items asking respondents how often they experience certain situations of discrimination. Responses are given on a 6-point scale where 1 = never and 6 = almost everyday. Total scores range from 9 to 54 where higher scores indicate experiencing increased discrimination.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  40. Change in Experiences of Discrimination (EOD) Scale Score

    The Experiences of Discrimination Questionnaire is an 11-item instrument assessing experiences of discrimination because of race, ethnicity, or color. Respondents indicate if they have or have not experienced 9 situations of discrimination (no = 0 and yes = 1), and then there are two questions about how often respondents feel that discrimination occurs that are score as 1 = never and 4 = often. Total scores range from 2 to 17 where higher scores indicate greater experiences of discrimination.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  41. Change in Epworth Sleepiness Scale Score

    The Epworth Sleepiness Scale is an 8-item instrument assessing level of daytime sleepiness. Responses are given on a 4-point scale where 0 = would never doze and 3 = high chance of dozing. Total scores range from 0 to 24, where scores between 0 and 10 are considered normal and scores above 16 are indicative of high levels of excessive daytime sleepiness.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  42. Change in Penn Computerized Neuropsychological Battery (Penn CNP) Performance

    This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery (which include measures of sustained attention and working memory) will be administered, which take approximately 30 minutes to complete.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  43. Change in State Scale of Dissociation (SSD) Score

    The SSD is a 56-item self-report measure that assess present state dissociative symptoms. The SSD seven subscales are derealization, depersonalization, identity confusion, identity alteration, conversion, amnesia, and hypermnesia. Responses are given on a 10-point scale where 0 = not at all, and 9 = very much so. A total score is calculated as the mean of all survey items. Total scores range from 0 to 9 where higher scores indicate greater dissociation. This will be administered prior to and after each intervention appointment and MRI visit.

    Time frame: Baseline to Week 6 (before and after each study visit)

  44. Change in Affective Number Stroop (ANS) Task Performance

    During the ANS task, participants are instructed to rapidly identify the number of numbers in a given display while ignoring evocative distractor images (trauma-relevant scenes). In these trials, the number of numbers presented is either consistent or inconsistent with the actual number displayed, such that there are both congruent and incongruent trials. The participants will be presented with positive and neutral pictures in addition to the negative trauma-relevant images. The task will be completed in the MRI scanner during both the pre- and post-treatment sessions. This task is meant to evoke the attentional problems that many Grady Trauma Project participants encounter while performing daily tasks by engaging attentional control resources and including images that are relevant to participants' traumas.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  45. Change in Stroop Color and Word Test (SCWT) Time

    During the Stroop Color and Word Test, lists of color words printed in black ink, printed in ink the color of the word, and printed in ink in a color that does not match the word. Participants are asked to read the words in the first two conditions but to then state the color of the ink rather than the word during the inconsistent color condition. The SCWT shows that people take longer to name the color of the ink that color-words are written in when the ink color does not match the word than when they match. The time it takes to complete condition where the ink color does not match the word will be assessed in seconds.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  46. Change in Number Stroop Test Time

    The Counting Stroop is a validated Stroop task variant. In this task, participants report the number of words (one to four) appearing on the screen, regardless of word meaning, by pressing a button. Neutral-word control trials contain single semantic category common animals (i.e. dog written three times) while interference trials contain number words that are incongruent with the correct response (i.e. 'two' written four times). The time it takes to say the number of words will be assessed in seconds.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

  47. Change in Pittsburgh EEG Accessible Calibration Environment (PEACE) Performance

    This 6-minute task consists of multiple common cognitive and affective operations including open and closed eyes resting state, passive viewing of affective images, rumination, counting backwards, and finger movement. It allows derivation of physiological profiles for use in signal classification on the other tasks.

    Time frame: Baseline, Week 6 (post-intervention), 3 Months Post-intervention, 6 Months Post-intervention

06

Study locations

1 of 2 sites recruiting
  • Grady Hospital
    Atlanta, Georgia 30303, United States
    • Negar Fani, PhD · Principal investigator
    Recruiting
  • Western Psychiatric Institute and Clinic
    Pittsburgh, Pennsylvania 15213, United States
    Completed
07

References and documents

Individual participant data

Plan to share: Yes — De-identified clinical and neuroimaging data will be shared. Data will be uploaded continuously to a public repository for clinical trials (e.g., NDAR) as specified by the program official.

Supporting information: Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04670640
Lead sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Negar Fani (Associate Professor, Emory University) — Principal investigator
First posted
Dec 17, 2020
Start date
Sep 18, 2021
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Negar Fani, PhD
Contact
nfani@emory.edu
404-712-0354
Greg Siegle, PhD
Contact
gsiegle@pitt.edu
412-864-3501
Negar Fani, PhD
principal investigator · Emory University
Greg Siegle, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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