Actively Recruiting
Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis
Led by Duke University · Updated on 2026-03-04
240
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how combining emotion regulation skills training with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) affects brain function and behavior in adults experiencing difficulties calming down when upset. This study focuses on adults diagnosed with various DSM-5 disorders related to mood, anxiety, stress, and emotion regulation. The goal is to understand how neurostimulation may improve emotion regulation and identify brain changes and personal biomarkers linked to treatment response. Participants are randomly assigned to one of three groups: one group learns cognitive restructuring while receiving rTMS over their dlPFC; the second group learns cognitive restructuring while receiving electrical scalp stimulation; and the third group receives emotional awareness training combined with rTMS. All interventions are delivered in a single session, with neurostimulation targeted using individual brain imaging results. After the session, participants complete follow-up visits at one week and one month for additional brain scans, interviews, and assessments. Throughout the study, participants undergo brain imaging while performing emotion regulation tasks to measure neural activity changes. Researchers monitor physiological arousal during the intervention and assess emotion regulation through self-reports and cognitive measures at follow-up visits. The study lasts about one month from initial assessment to final follow-up, including detailed evaluations of heart rate variability, brain connectivity, and self-efficacy related to emotional control. This research aims to develop new treatments based on neuroscience for emotional difficulties across different disorders.
CONDITIONS
Brief Title
Neurostimulation Versus Therapy for Problems With Emotions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years
- Elevated score on Difficulties with Emotion Regulation Scale (DERS total score ≥90)
- Stable psychotherapy regimen (including none) for at least 4 weeks, excluding current cognitive behavioral therapy
- Low use of cognitive restructuring skills (ERQ restructuring subscale average score < 4.7)
- Diagnosis of at least one mood, anxiety, stress, OCD, impulse control, ADHD, or eating disorder (excluding severe anorexia)
- Agreement to maintain stable psychotropic medication dose if applicable and stable for past 4 weeks
- No prior exposure to repetitive transcranial magnetic stimulation (rTMS)
You will not qualify if you...
- Current hypomania (except Bipolar II without current hypomanic episode)
- Diagnosis or history of psychotic disorder or psychotic features
- Diagnosis of Bipolar I disorder
- Current moderate or severe alcohol or substance use disorder, or history of severe alcohol use disorder
- Inability to read, blindness, deafness, or unwillingness to consent
- Non-English speaker
- Verbal IQ below 90 on the North American Adult Reading Test (NART)
- Current uncontrolled anorexia or other condition requiring hospitalization
- High suicide risk with recent attempt or current plan/intent
- Serious medical illness including severe migraines
- Recent changes in psychotropic medications within 4 weeks or plans to change during study
- History of seizures except therapeutic ECT-induced seizures or childhood febrile seizures
- History of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, cranial metal implants, or brain lesions unsafe for TMS
- Presence of devices affected by TMS such as pacemakers or cochlear implants
- Tendonitis in left elbow, hand, or wrist
- Conditions with increased intracranial pressure or neurological diseases like dementia, Parkinson's, Huntington's, or multiple sclerosis
- Use of Wellbutrin over 300mg daily or stimulant medications above FDA recommendations
- Use of investigational drugs or devices within 4 weeks
- Pregnancy
- Metal in body preventing MRI or severe claustrophobia
- Prisoner or in police custody, or pending court case affecting participation
- Prior TMS treatment
- Cognitive behavioral therapy in past 4 weeks or planned during study
- Weight over 300 pounds (MRI scanner limit)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive one session of neurostimulation combined with behavioral skills training targeting emotion regulation. This includes training in cognitive restructuring or emotional awareness paired with either repetitive transcranial magnetic stimulation (rTMS) or electrical scalp stimulation over the dorsolateral prefrontal cortex (dlPFC). Physiological arousal will be monitored during this session.
1 in-person neurostimulation and training visit
Duration - 1 week after neurostimulation
Participants undergo a follow-up functional brain scan and bio-behavioral assessments to evaluate immediate neural and behavioral changes after the neurostimulation session.
1 follow-up visit (in-person)
Duration - 1 month after the 1 week follow-up
Participants complete a final follow-up visit one month after the initial follow-up to assess emotion regulation outcomes, complete self-report questionnaires, and participate in an exit interview regarding treatment acceptability and expectancies.
1 final follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
Z
Zoe Brasher
L
Lisalynn D Kelley, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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