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Mechanistic Interventions for Dissociative Disorders (MIND Trial)
N/A
Recruiting
Led By Greg Siegle, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6 (post-intervention), 3 months post-intervention, 6 months post-intervention
Awards & highlights
MIND Trial Summary
This trial will test whether different interventions can change the neural networks associated with attentional control and interoceptive awareness in people who have dissociative symptoms from trauma.
Who is the study for?
This trial is for people who feel disconnected from themselves (dissociation) after a traumatic event and score at least 7 on the MDI depersonalization scale. Participants must have experienced significant trauma as defined by DSM-5 criteria and be willing to join the study. Those with severe substance dependence, active psychosis, or serious cognitive issues cannot participate.Check my eligibility
What is being tested?
The study tests if focusing on breathing without distractions or using vibration can influence brain networks related to attention control and body awareness in traumatized individuals with dissociative symptoms. It's conducted at Emory University and University of Pittsburgh.See study design
What are the potential side effects?
Potential side effects are not explicitly mentioned but may include discomfort due to focus exercises or vibrations, emotional distress from recalling traumatic events during assessments, or fatigue from participation.
MIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6 (post-intervention), 3 months post-intervention, 6 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6 (post-intervention), 3 months post-intervention, 6 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Affective Number Stroop (ANS) Task Performance
Change in Attentional Control Scale (ACS) Score
Change in Change in Life Events Checklist Score
+44 moreMIND Trial Design
4Treatment groups
Experimental Treatment
Group I: Vibration With Breath FocusExperimental Treatment2 Interventions
Participants receiving the vibration with breath focus study intervention.
Group II: VibrationExperimental Treatment1 Intervention
Participants receiving the vibration study intervention.
Group III: Screens FreeExperimental Treatment1 Intervention
Participants receiving the screens free study intervention.
Group IV: Breath FocusExperimental Treatment1 Intervention
Participants receiving the breath focus study intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibration
2016
Completed Phase 2
~750
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,583 Total Patients Enrolled
1 Trials studying Dissociation
24 Patients Enrolled for Dissociation
Emory UniversityLead Sponsor
1,647 Previous Clinical Trials
2,564,441 Total Patients Enrolled
Greg Siegle, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to participate in the study.You have gone through a traumatic experience that meets the criteria set by the DSM-5. This will be checked by asking you to fill out a Life Events Checklist.I am willing to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vibration
- Group 2: Vibration With Breath Focus
- Group 3: Screens Free
- Group 4: Breath Focus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dissociation Patient Testimony for trial: Trial Name: NCT04670640 — N/A
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