RecruitingNot ApplicableNCT05712057

Neurostimulation Versus Therapy for Problems With Emotions

Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis


Sponsor

Duke University

Enrollment

240 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing transcranial magnetic stimulation (TMS — a non-invasive brain stimulation technique) versus standard therapy for people who have significant difficulty managing their emotions, which is a challenge in many mental health conditions. **You may be eligible if...** - You are between 18 and 55 years old - You have significant difficulty regulating your emotions (high score on an emotion regulation scale) - You meet criteria for at least one mood, anxiety, ADHD, OCD, impulse control, or eating disorder - You have not previously received TMS treatment - Your current medication type and dose has been stable for the past 4 weeks and you are willing to keep it the same during the study **You may NOT be eligible if...** - You are currently experiencing hypomania or have bipolar I disorder - You have a history of psychosis or schizophrenia - You have a current moderate-to-severe alcohol or substance use disorder - You are blind, deaf, or unable to consent - You have a metal implant or other contraindication to TMS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)

high frequency rTMS over the right dlPFC

DEVICEelectrical scalp stimulation

electrical scalp stimulation over the right dlPFC

BEHAVIORALCognitive 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.

BEHAVIORALEmotional 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.


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT05712057


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