Mechanistic Interventions and Neuroscience of Dissociation

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Dissociation

Being tested

Vibration, Breath Focus, No Distractions

Keywords

Trauma, PTSD, Mindfulness, Meditation, Neuroimaging, MRI

Medical subject headings

Dissociative Disorders, Wounds and Injuries, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• VibrationDevice

  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.

• Breath FocusBehavioural

  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.

• No DistractionsBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Dec 2020
2. Study start18 Sep 2021
3. Primary completionMar 2027 (estimated)
4. Study completionMar 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for DissociationStudies of the same condition, open and under way.
• More trials run by Emory UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.