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Recruiting NCT05712057

Neurostimulation Versus Therapy for Problems With Emotions

Trial Parameters

Condition Emotion Regulation
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2023-05-15
Completion 2027-10-31
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS)electrical scalp stimulationCognitive Restructuring

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.

Eligibility Criteria

Inclusion Criteria: * 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) * 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). * Naïv

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