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Compares treatment options for Emotion Regulation
Official title Neurostimulation Versus Therapy for Problems With Emotions
ClinicalTrials.gov ID: NCT05712057
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- unable to read, blind, or deaf, or unwilling to give consent
- non-English speaker,
See the full eligibility 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...
- 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...
- Naïve to rTMS
- 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 people may be included in the study), history of epilepsy in self or first degree relatives, stroke...
- conditions associated with increased intracranial pressure, space occupying brain lesion (considered significant and unsafe for TMS by the study MD), transient ischemic attack, cerebral aneurysm, dementia, Parkinson's...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.