Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712057
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-01-12
Brief Title:
Neurostimulation Versus Therapy for Problems With Emotions
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation A Component Analysis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH129302-01A1 | NIH | None | httpsreporternihgovquickSearch1R01MH129302-01A1 |