Neurostimulation Versus Therapy for Problems With Emotions
Emotion Regulation, Mood Disorders, Stress Disorder
About this trial
This is an interventional treatment trial for Emotion Regulation focused on measuring Emotion Dysregulation, Distress Intolerance, Neuromodulation, Neurostimulation, TMS, cognitive restructuring, regulation skills, neuroimaging, Emotion regulation
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). Naïve to rTMS Exclusion Criteria: current hypomania (Note: Bipolar II w/o current hypomanic episode is ok for inclusion) 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) conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis on medications that reduce seizure threshold (e.g., stimulants, Wellbutrin, Clozaril, Provigil) 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)
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)
Cognitive Restructuring + scalp electrical stimulation
Emotional Awareness Training + 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.
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.
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.