Emotion RegulationNCT05712057
Neurostimulation Versus Therapy for Problems With Emotions
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), electrical scalp stimulation and Cognitive Restructuring in people with Emotion Regulation and Mood Disorders, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Emotion Regulation, Mood Disorders, Stress Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), electrical scalp stimulation and Cognitive Restructuring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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: Both current or partial remission of the disorder will be ok for inclusion into the study.
- 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 medical emergency requiring changes in medication).
- Naïve to rTMS
Who cannot join
- 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,
Show all 22Show fewer
- 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 subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesions that are contraindications for TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), have left elbow/hand/wrist tendonitis
- 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 or Huntington's disease, multiple sclerosis
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Andrada D Neacsiu, PhD, 919-684-6714, andrada.neacsiu@duke.edu
Andrada D Neacsiu, PhD
About this study
Official title: Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis
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.
Read the 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.
- Conditions
- Emotion Regulation, Mood Disorders, Stress Disorder, Anxiety Disorders, OCD, Impulse Control Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), electrical scalp stimulation, Cognitive Restructuring, Emotional Awareness Training
- Keywords
- Emotion Dysregulation, Distress Intolerance, Neuromodulation, Neurostimulation, TMS, cognitive restructuring, regulation skills, neuroimaging, Emotion regulation
- Medical subject headings
- Emotional Regulation, Mood Disorders, Stress Disorders, Traumatic, Anxiety Disorders, Disruptive, Impulse Control, and Conduct Disorders, Feeding and Eating Disorders, Obsessive-Compulsive Disorder, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called rTMS
high frequency rTMS over the right dlPFC
electrical scalp stimulationDevice
electrical scalp stimulation over the right dlPFC
Cognitive RestructuringBehavioural
Also called CR
Cognitive 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 TrainingBehavioural
Also called EAT
Emotional 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Cognitive Restructuring |
| Cognitive Restructuring + scalp electrical stimulation | Active comparator | 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. Receives: Device: electrical scalp stimulation; Behavioral: Cognitive Restructuring |
| Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS) | Active comparator | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Emotional Awareness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within a month of the initial assessment
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.
Measured: Within a month of the initial assessment
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
Measured: baseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation)
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
Measured: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrast
Change in the maximum activation in the vmPFC from pre-post neuroimaging in the contrast of interest
Measured: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the insular cortex for the [restructure-flow_negative] contrast
Change in the maximum activation in the insula from pre-post neuroimaging in the contrast of interest
Measured: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-insula connectivity pre-post neuromaging
Measured: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-amygdala connectivity pre-post neuromaging
Measured: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Secondary outcomes (10)
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)
Measured: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
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.
Measured: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
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
Measured: baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
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
Measured: baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Outcome Questionnaire (OQ-45) self-report change
Change in self-reported psychopathology as measured by the OQ-45 one week and one month after training. The Outcome Questionnaire-45 (OQ-45) is a 45-item self-report measure used to track severity of psychopathology throughout treatment. It consists of subscales that identify three types of problems that lead to general stress: psychological symptoms, interpersonal conflicts, and problems with social roles. Items are rated on a Likert scale ranging from 0 (never) to 4 (almost always). Scores range from 0 to 180. Higher scores indicate higher psychopathological distress than lower scores.
Measured: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Cognitive Skills Questionnaire (CSQ) self-report change
Change in self-reported use of cognitive skills as measured by the CSQ one week and one month after training. The CSQ is the Unified Protocol Cognitive Skills Questionnaire (UPCSQ; unpublished) that contains 8 items that ranges from "1" Never to "5" Always or When Needed with higher scores indicating more use of tools or skills than lower scores. Scores range from 8 to 40 (highest skill use).
Measured: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Self Efficacy with Emotion Regulation (PROMIS-SEME)
Change in effective regulation as measured by PROMIS-SEME from baseline to follow up. PROMIS Self-Efficacy for Managing Emotions measures one's confidence to manage emotions such as anxiety, helplessness, and discouragement on a scale of 1 "not at all confident" to 5 "I am very confident." There are total of 25 items with a score ranging from 25 to 125. Higher scores indicate higher confidence in the ability to use emotion regulation skills. Scores are then reported using the PROMIS manual for T-scores.
Measured: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Change in subjective units of distress (SUDS)
SUDS measured after baseline, stressor and every three minutes during regulation, including at the end of regulation during the neurostimulation experiment
Measured: Neurostimulation visit (which will occur within a month of the initial assessment)
HF-HRV during regulation block at follow up
Change in HF-HRV mean during regulation block of stressor task at neurostimulation visit at follow-up
Measured: one week follow-up, 1 month follow-up
Time to return to HR baseline measured during regulation period at follow up
time it takes to return baseline HR will be calculated during the behavioral stressor computer task at follow up
Measured: one week follow-up, 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start15 May 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 (G1) and 2 (G2) participants will receive training in cognitive restructuring, while Group 3 (G3) participants will receive training in emotional awareness. All participants will undergo negative emotion induction using autobiographical stressors. Depending on group participants could receive one of two types of neurostimulation . Randomization procedures will match subjects on: 1) severity of emotional dysregulation (high/very high), 2) sex at birth, and 3) treatment status (psychotropics/no psychotropics).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Andrada D Neacsiu, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712057
- Sponsor's protocol ID
- Pro00111390
- Other IDs
- R01MH129302-01A1
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many NIH studies are stored and managed. NDA is run by the National Institute of Mental Health (NIMH) that allows researchers studying mental illness and brain science to collect and share deidentified information with each other. When the study team sends the data to the NIMH, they will do this through a password secure system where participants are identified by a specific GUID which is a unique # representing 1 specific person in the nation. NIMH will also report to Congress and on its website about the different studies using NDA data. Participants can decide that they do not want to share their information to NDA.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis
- ClinicalTrials.gov ID
- NCT05712057
- Acronym / sponsor ID
- Pro00111390
- Conditions
- Emotion Regulation, Mood Disorders, Stress Disorder, Anxiety Disorders, OCD, Impulse Control Disorder
- Keywords
- Emotion Dysregulation, Distress Intolerance, Neuromodulation, Neurostimulation, TMS, cognitive restructuring, regulation skills, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1 (G1) and 2 (G2) participants will receive training in cognitive restructuring, while Group 3 (G3) participants will receive training in emotional awareness. All participants will undergo negative emotion induction using autobiographical stressors. Depending on group participants could receive one of two types of neurostimulation . Randomization procedures will match subjects on: 1) severity of emotional dysregulation (high/very high), 2) sex at birth, and 3) treatment status (psychotropics/no psychotropics).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Cognitive RestructuringGroup 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. |
| Cognitive Restructuring + scalp electrical stimulation | Active comparator | Device: electrical scalp stimulation, Behavioral: Cognitive RestructuringGroup 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. |
| Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS) | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Emotional Awareness TrainingGroup 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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: Both current or partial remission of the disorder will be ok for inclusion into the study.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: rTMShigh frequency rTMS over the right dlPFC | Device | Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS), Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS) |
| electrical scalp stimulationelectrical scalp stimulation over the right dlPFC | Device | Cognitive Restructuring + scalp electrical stimulation |
| Cognitive RestructuringAlso: CRCognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. | Behavioural | Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS), Cognitive Restructuring + scalp electrical stimulation |
| Emotional Awareness TrainingAlso: EATEmotional 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. | Behavioural | Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS) |
Primary outcome
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day
Time frame: Within a month of the initial assessment
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
Time frame: Within a month of the initial assessment
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
Time frame: baseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation)
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
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the maximum activation in the dmPFC from pre-post neuroimaging in the contrast of interest
Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrast
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the maximum activation in the vmPFC from pre-post neuroimaging in the contrast of interest
Change in the insular cortex for the [restructure-flow_negative] contrast
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Change in the maximum activation in the insula from pre-post neuroimaging in the contrast of interest
Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative]
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-insula connectivity pre-post neuromaging
Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative]
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-amygdala connectivity pre-post neuromaging
10 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS) self-report change
Time frame: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Emotion Regulation Questionnaire (ERQ) self-report change
Time frame: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Change in the dlPFC for the [restructure - flow_negative] contrast
Time frame: baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Change in the amygdala for the [restructure - flow_negative] contrast
Time frame: baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
Outcome Questionnaire (OQ-45) self-report change
Time frame: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Cognitive Skills Questionnaire (CSQ) self-report change
Time frame: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Self Efficacy with Emotion Regulation (PROMIS-SEME)
Time frame: Baseline, 1 week follow-up after neurostimulation, 1 month follow-up
Change in subjective units of distress (SUDS)
Time frame: Neurostimulation visit (which will occur within a month of the initial assessment)
HF-HRV during regulation block at follow up
Time frame: one week follow-up, 1 month follow-up
Time to return to HR baseline measured during regulation period at follow up
Time frame: one week follow-up, 1 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many NIH studies are stored and managed. NDA is run by the National Institute of Mental Health (NIMH) that allows researchers studying mental illness and brain science to collect and share deidentified information with each other. When the study team sends the data to the NIMH, they will do this through a password secure system where participants are identified by a specific GUID which is a unique # representing 1 specific person in the nation. NIMH will also report to Congress and on its website about the different studies using NDA data. Participants can decide that they do not want to share their information to NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrada D Neacsiu, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), electrical scalp stimulation and Cognitive Restructuring in people with Emotion Regulation and Mood Disorders, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Brasher (9196846785, zoe.brasher@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day (time frame: Within a month of the initial assessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.