Neurostimulation Versus Therapy for Problems With Emotions
NCT ID: NCT05712057
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-05-15
2027-07-01
Brief Summary
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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.
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Detailed Description
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The primary aim of this project is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills with excitatory neurostimulation 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. To achieve these aims, 240 rTMS naïve, community adults who meet criteria for a DSM-5 disorders (excluding if co-occurring anorexia, moderate to severe alcohol and substance use, bipolar I, or psychotic disorders) and who self-report high emotional dysregulation will participate in brain imaging while undergoing an emotional regulation task. Both structural and functional MRI (fMRI) images will be collected. Participants will be randomly assigned to one of three experimental groups that blend neurostimulation and behavioral skills training in different ways. Participants will be reminded of recent autobiographical stressors and will undergo different types of neurostimulation, targeted using fMRI results. Physiological arousal will be monitored throughout the experimental visit. Following this training, 1 week later, participants will undergo another functional scan to assess for immediate neural and behavioral changes. Bio-behavioral measures of emotion regulation will be assessed at this one week visit. The 1-month follow up will occur 1 month after the one week follow-up visit. At this final follow-up visit, participants will also complete an exit interview that assesses acceptability and expectancies as well as a battery of self reports. One final set of bio-behavioral measures of emotion regulation will be completed as well. If successful, the investigators' line of research will provide key mechanistic information to develop a novel transdiagnostic treatment for DSM-5 disorders.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)
Group 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.
Repetitive Transcranial Magnetic Stimulation (rTMS)
high frequency rTMS over the right dlPFC
Cognitive Restructuring
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.
Cognitive Restructuring + scalp electrical stimulation
Group 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.
electrical scalp stimulation
electrical scalp stimulation over the right dlPFC
Cognitive Restructuring
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 + Repetitive Transcranial Magnetic Stimulation (rTMS)
Group 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.
Repetitive Transcranial Magnetic Stimulation (rTMS)
high frequency rTMS over the right dlPFC
Emotional Awareness Training
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.
Interventions
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Repetitive Transcranial Magnetic Stimulation (rTMS)
high frequency rTMS over the right dlPFC
electrical scalp stimulation
electrical scalp stimulation over the right dlPFC
Cognitive Restructuring
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* meets criteria for at least one mood (including Bipolar II w/o current hypomania), anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (except exclusionary diagnoses such as severe anorexia). Note: Both current or partial remission of the disorder will be ok for inclusion into the study.
* verbal agreement to maintain dose of prescribed psychotropic medication (if any) constant throughout the study, provided they are stable on it for the past 4 weeks (except exclusion medication and except if there is a medical emergency requiring changes in medication).
* Naïve to rTMS
Exclusion Criteria
* 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 lesion, 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, 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
* Pregnancy
* metal in body that would exclude them from the MRI scan; severe claustrophobia
* is a prisoner or in police custody at time of screening, or has pending court case jeopardizing the participation in the study
* has had TMS in their lifetime
* has had CBT in the past 4 weeks or plans to start therapy during the study
* weighs over 300 pounds (could not fit in MRI scanner)
18 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Andrada D Neacsiu, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00111390
Identifier Type: -
Identifier Source: org_study_id
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