Neurostimulation Versus Therapy for Problems With Emotions
Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis
2 other identifiers
interventional
240
1 country
1
Brief Summary
The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 3, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 4, 2026
March 1, 2026
4.5 years
January 12, 2023
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day
Calculation of physiological data High frequency HRV (HF-HRV) during regulation blocks during the neurostimulation day accounting for baseline controlling for baseline HF-HRV
Within a month of the initial assessment
Time to return to Heart Rate (HR) baseline measured during regulation period
Following each negative mood induction during the neurostimulation experiment, the time it takes to return baseline HR will be calculated for each of the three regulation periods.
Within a month of the initial assessment
Change in the ventrolateral prefrontal cortex (vlPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the vlPFC from pre-post neuroimaging in the contrast of interest
baseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation)
Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the dmPFC from pre-post neuroimaging in the contrast of interest
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the vmPFC from pre-post neuroimaging in the contrast of interest
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the insular cortex for the [restructure-flow_negative] contrast
Change in the maximum activation in the insula from pre-post neuroimaging in the contrast of interest
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-insula connectivity pre-post neuromaging
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-amygdala connectivity pre-post neuromaging
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Secondary Outcomes (10)
Difficulties in Emotion Regulation Scale (DERS) self-report change
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Emotion Regulation Questionnaire (ERQ) self-report change
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Change in the dlPFC for the [restructure - flow_negative] contrast
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Change in the amygdala for the [restructure - flow_negative] contrast
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Outcome Questionnaire (OQ-45) self-report change
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
- +5 more secondary outcomes
Other Outcomes (4)
Change in vmPFC-insula connectivity during [restructure - flow_negative]
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Cognitive flexibility inventory (CFI) and cognitive control and flexibility inventory (CCFI)
Baseline
Wisconsin Card Sorting Task
Baseline
- +1 more other outcomes
Study Arms (3)
Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)
EXPERIMENTALGroup 1 (G1)- 80 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while receiving rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.
Cognitive Restructuring + scalp electrical stimulation
ACTIVE COMPARATORGroup 2 (G2) - 80 eligible participants will receive training in CR. These participants will use CR while receiving scalp electrical stimulation over their individual dlPFC target and will partake in short term and long term follow up testing.
Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)
ACTIVE COMPARATORGroup 3 (G3) - 80 eligible participants will receive emotional awareness training. These participants will receive rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.
Interventions
Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal.
Emotional awareness training is a behavioral intervention through which participants learn how to identify and evaluate their emotions and the components that make up each emotion.
high frequency rTMS over the right dlPFC
electrical scalp stimulation over the right dlPFC
Eligibility Criteria
You may qualify if:
- age 18 to 55
- elevated overall score on Difficulties with Emotion Regulation Scale (DERS total score \>=90)
- has been in the same type of psychotherapy (including none) for the last 4 weeks/1mo (\*except for current CBT) and is willing to stay on the same regimen throughout the study.
- low self-reported use of cognitive restructuring (ERQ restructuring subscale average score \< 4.7)
- Naïve to rTMS
You may not qualify if:
- meets diagnostic criteria for current or history of psychotic disorder, or psychotic features,
- meets diagnostic criteria for Bipolar I disorder
- meets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorder
- unable to read, blind, or deaf, or unwilling to give consent
- non-English speaker,
- verbal IQ \< 90 on the North American Adult Reading Test (NART).
- current uncontrolled anorexia or other condition requiring hospitalization
- high risk for suicide defined as either having attempted suicide in past 6 months or reporting current suicidal ideation that includes a method, plan, or intent to die
- current serious medical illness, including current severe migraine headaches
- started/changed psychotropic medications in the prior 4 weeks, or plans to change medication during the study
- history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesions that are contraindications for TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), have left elbow/hand/wrist tendonitis
- conditions associated with increased intracranial pressure, space occupying brain lesion (considered significant and unsafe for TMS by the study MD), transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis
- Wellbutrin \>300mg per day or on daily stimulant/ADHD medications above the recommended FDA daily recommendations
- use of investigational drug or devices within 4 weeks of screening
- cochlear implants
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrada D Neacsiu, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- All participants will engage in a behavioral training session (either cognitive restructuring or emotional awareness training). The clinician who will conduct this behavioral session will be kept blind to thetype of neurostimulation the participant will receive. The neurostimulation technician will be kept blind to the behavioral training that the participant receives. Participants will only be told about the specific type of neurostimulation they receive at the end of the study to protect against different expectations.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
February 3, 2023
Study Start
May 15, 2023
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Either on a rolling basis over the life of the grant/project per NDA's sharing calendar. Otherwise, within 6 months of completing participant data collection or very soon after publication of primary aims.
- Access Criteria
- Users with NDA credentials must submit Data Access Requests for one NDA Permission Group at a time. Each DAR requires an NDA Data Use Certification (DUC) signed by the lead recipient and an authorized Signing Official from the recipient's research institution. All recipients on a Data Access Request/Data Use Certification must be affiliated with the lead recipient's research institution. If the Lead Recipient on a DUC changes institutions, they may identify another Recipient on the DUC as a replacement. Data Access Requests for a given NDA Permission Group are reviewed by one NIH-staffed Data Access Committee (DAC). Detailed information about NDA permission groups is maintained at https://nda.nih.gov/nda/about-us.html. When approved to access, teams have access to query and download all data available using the NDA Query Tool and NDA download tools.
Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many NIH studies are stored and managed. NDA is run by the National Institute of Mental Health (NIMH) that allows researchers studying mental illness and brain science to collect and share deidentified information with each other. When the study team sends the data to the NIMH, they will do this through a password secure system where participants are identified by a specific GUID which is a unique # representing 1 specific person in the nation. NIMH will also report to Congress and on its website about the different studies using NDA data. Participants can decide that they do not want to share their information to NDA.