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.
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)
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
Parallel
Repetitive Transcranial Magnetic Stimulation (rTMS)
Devicehigh frequency rTMS over the right dlPFC
electrical scalp stimulation
Deviceelectrical scalp stimulation over the right dlPFC
Cognitive Restructuring
BehavioralCognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal.
Emotional Awareness Training
BehavioralEmotional awareness training is a behavioral intervention through which participants learn how to identify and evaluate their emotions and the components that make up each emotion.
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day
Calculation of physiological data High frequency HRV (HF-HRV) during regulation blocks during the neurostimulation day accounting for baseline controlling for baseline HF-HRV
Time to return to Heart Rate (HR) baseline measured during regulation period
Following each negative mood induction during the neurostimulation experiment, the time it takes to return baseline HR will be calculated for each of the three regulation periods.
Change in the ventrolateral prefrontal cortex (vlPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the vlPFC from pre-post neuroimaging in the contrast of interest
Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the dmPFC from pre-post neuroimaging in the contrast of interest
Difficulties in Emotion Regulation Scale (DERS) self-report change
Change in self-reported DERS will be investigated immediately after the followup neuroimaging session and one month after training. DERS inclusion for study is a score of 90 or higher. Min-Max score ranges from 36-180 (with higher scores signifying more difficulties with emotion regulation)
Emotion Regulation Questionnaire (ERQ) self-report change
Change in Self-reported use of Cognitive Restructuring (CR) as measured with the Emotion Regulation Questionnaire (ERQ) one week and one month after training. We will also examine pre-post changes in ERQ-Reappraisal scale using a similar growth model approach, accounting for severity of psychopathology and baseline. The ERQ is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal (6 scale items) and (2) Expressive Suppression (4 scale items). Scores for the 2 scales are reported the average score of the total items in that scale. The lower the average score on the reappraisal scale the more problems with regulating emotions.
Change in the dlPFC for the [restructure - flow_negative] contrast
Change in the maximum activation in the dlPFC from pre-post neuroimaging in the contrast of interest
Change in the amygdala for the [restructure - flow_negative] contrast
Change in the maximum activation in the amygdala from pre-post neuroimaging in the contrast of interest
Change in vmPFC-insula connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in vmPFC-insula connectivity pre-post neuromaging
Cognitive flexibility inventory (CFI) and cognitive control and flexibility inventory (CCFI)
CFI and CCFI total scores will be used as a moderator of outcomes. The CFI is a 20-item self-report measure to monitor how often individuals engaged in cognitive behavioral thought challenging interventions. Scores consist of a total CFI score and two subscale scores. The total score ranges between 20 and 140, where higher scores indicate more cognitive flexibility. The CCFI is an 18 item measure that assesses an individual's perceived ability to exhibit control over their thoughts and behavior in a stressful situation on a scale of "1" Strongly Disagree to "7" Strongly agree with a range from 18-126. Higher scores on the CCFQ were most strongly related to greater cognitive reappraisal as well as less perseverative thinking and rumination.
Wisconsin Card Sorting Task
Behavioral measurement of cognitive flexibility achieved with the wisconsin card sort will be used as a moderator of outcomes
Affect Intensity Measure (AIM)
AIM total score will be used as a moderator of outcomes. The AIM is a 40-item questionnaire designed to measure the characteristic strength or weakness with which one experiences emotion where participants rate from "1" Never to "6" Always with higher scores meaning higher emotion intensity than lower scores.
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Duke University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
