About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- electrical scalp stimulation
- Cognitive Restructuring
- Emotional Awareness Training
Treatment groups
Sponsors and collaborators
Duke University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator