Duke University
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.
Emotion Regulation
Mood Disorders
Stress Disorder
Anxiety Disorders
OCD
Impulse Control Disorder
Eating Disorders
Emotional Dysfunction
Emotional Instability
Emotional Distress
Emotional Maladjustment
Emotional Impulsivity
Obsessive-Compulsive Disorder
Emotion Dysregulation
Borderline Personality Disorder
Repetitive Transcranial Magnetic Stimulation (rTMS)
electrical scalp stimulation
Cognitive Restructuring
Emotional Awareness Training
Not Applicable
Emotional dysregulation constitutes a serious public health problem and novel approaches are needed to effectively address it transdiagnostically. Despite rapid advancements in affective and cognitive neuroscience, there have been few attempts to translate basic findings into novel interventions. In addition, the relevance of different nodes in the emotion regulation network to psychopathology and to successful reduction of emotional arousal is not yet fully understood. Noninvasive neurostimulation, such as repetitive transcranial magnetic stimulation (rTMS), is a powerful tool with which dysfunction can be alleviated temporarily, by modulating neural activation. Therefore, the objective of the current study is to examine immediate neural and behavioral changes following neuromodulation enhanced emotion regulation training for transdiagnostic adults who report difficulties calming down when upset. The central hypothesis is that neurostimulation enhances the acquisition of emotion regulation skills and leads to remediated neural function in the emotion regulation network. The investigators' long-term goal is to develop novel interventions that harness neuroscientific findings to advance behavioral treatments. The primary aim of this project is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills with excitatory neurostimulation 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. To achieve these aims, 240 rTMS naïve, community adults who meet criteria for a DSM-5 disorders (excluding if co-occurring anorexia, moderate to severe alcohol and substance use, bipolar I, or psychotic disorders) and who self-report high emotional dysregulation will participate in brain imaging while undergoing an emotional regulation task. Both structural and functional MRI (fMRI) images will be collected. Participants will be randomly assigned to one of three experimental groups that blend neurostimulation and behavioral skills training in different ways. Participants will be reminded of recent autobiographical stressors and will undergo different types of neurostimulation, targeted using fMRI results. Physiological arousal will be monitored throughout the experimental visit. Following this training, 1 week later, participants will undergo another functional scan to assess for immediate neural and behavioral changes. Bio-behavioral measures of emotion regulation will be assessed at this one week visit. The 1-month follow up will occur 1 month after the one week follow-up visit. At this final follow-up visit, participants will also complete an exit interview that assesses acceptability and expectancies as well as a battery of self reports. One final set of bio-behavioral measures of emotion regulation will be completed as well. If successful, the investigators' line of research will provide key mechanistic information to develop a novel transdiagnostic treatment for DSM-5 disorders.}}
Study Type : | Interventional |
Estimated Enrollment : | 240 participants |
Masking : | Double |
Masking Description : | All participants will engage in a behavioral training session (either cognitive restructuring or emotional awareness training). The clinician who will conduct this behavioral session will be kept blind to thetype of neurostimulation the participant will receive. The neurostimulation technician will be kept blind to the behavioral training that the participant receives. Participants will only be told about the specific type of neurostimulation they receive at the end of the study to protect against different expectations. |
Primary Purpose : | Treatment |
Official Title : | Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis |
Actual Study Start Date : | May 15, 2023 |
Estimated Primary Completion Date : | May 31, 2027 |
Estimated Study Completion Date : | July 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Cognitive Restructuring + 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. |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: Cognitive Restructuring |
Active Comparator: Cognitive Restructuring + scalp electrical stimulation 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. |
Device: electrical scalp stimulation Behavioral: Cognitive Restructuring |
Active Comparator: Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS) 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. |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: Emotional Awareness Training |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Duke University Medical Center
Durham, North Carolina, United States, 27710