An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) and electrical scalp stimulation in Emotion Regulation, Mood Disorders and Stress Disorder, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
Among 196 studies in Emotional Regulation with a site in United States — 59 open to participants now, 75 under way, none of them phase 3. Emotional Regulation · United States.
Among the 196 studies in Emotional Regulation with a site in United States, this one is the 27th largest by planned enrollment of the 183 interventional ones that give a count, is one of 27 that started in 2023, is one of 174 with no phase, reaches primary completion later than 51 of the 74 other live ones, and was the 115th registered.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 240 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →59 of the 196 studies in Emotional Regulation with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 134 Emotional Regulation studies recruiting now, 36 (27%) set no upper age limit and 94 (70%) stop at 75 or younger; 45 take children under 18; 66 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →196 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 4 1
First in 1988; this study’s year is marked. 27 started in 2023.
Median enrollment 74 across the 183 interventional studies, 56 across the 13 observational. Of the 112 that completed or were terminated, 18 (16%) have results posted.
9 of 196 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 5 studies filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
28 of the studies in Emotional Regulation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05414708Walter Reed National Military Medical CenterArt Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms | 2026-12 |
| NCT06019377Portland State UniversityIntervention to Enhance Coping and Help-seeking Among Youth in Foster Care | 2026-12-31 |
| NCT06755827Texas Tech UniversityPilot Testing a Novel Approach to Pediatric Obesity Treatment | 2026-12-31 |
| NCT05651295Matthew Southward, PhDA Precision Medicine Approach to Target Engagement for Emotion Regulation | 2026-12-31 |
| NCT05781100California Polytechnic State University-San Luis ObispoInvestigating Baby Behavior and Family Technology Use Study | 2027-01-01 |
Among the 196 studies in Emotional Regulation with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
high frequency rTMS over the right dlPFC
Also known as: rTMS
electrical scalp stimulation over the right dlPFC
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.
Also known as: CR
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.
Also known as: EAT
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 frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)
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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: one week follow-up, 1 month follow-up
Change in vmPFC-insula connectivity during [restructure - flow_negative]
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in vmPFC-insula connectivity pre-post neuromaging
Time frame: baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation)
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.
Time frame: Baseline
Wisconsin Card Sorting Task
Behavioral measurement of cognitive flexibility achieved with the wisconsin card sort will be used as a moderator of outcomes
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Either on a rolling basis over the life of the grant/project per NDA's sharing calendar. Otherwise, within 6 months of completing participant data collection or very soon after publication of primary aims.
Access criteria: Users with NDA credentials must submit Data Access Requests for one NDA Permission Group at a time. Each DAR requires an NDA Data Use Certification (DUC) signed by the lead recipient and an authorized Signing Official from the recipient's research institution. All recipients on a Data Access Request/Data Use Certification must be affiliated with the lead recipient's research institution. If the Lead Recipient on a DUC changes institutions, they may identify another Recipient on the DUC as a replacement. Data Access Requests for a given NDA Permission Group are reviewed by one NIH-staffed Data Access Committee (DAC). Detailed information about NDA permission groups is maintained at https://nda.nih.gov/nda/about-us.html. When approved to access, teams have access to query and download all data available using the NDA Query Tool and NDA download tools.
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Oct 2027, 53 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 53 months is above that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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