Clinical Trials Logo

Clinical 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). 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05712057
Study type Interventional
Source Duke University
Contact Zoe Brasher
Phone 9196846785
Email zoe.brasher@duke.edu
Status Recruiting
Phase N/A
Start date May 15, 2023
Completion date July 1, 2027

See also
  Status Clinical Trial Phase
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Active, not recruiting NCT04136054 - Better Sleep in Psychiatric Care - Anxiety and Affective Disorders N/A
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT04647318 - Physiological Response to Self-compassion Versus Relaxation N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Completed NCT05078450 - Mood Lifters Online for Graduate Students and Young Professionals N/A
Not yet recruiting NCT06162624 - Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons N/A
Not yet recruiting NCT05863637 - Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting N/A
Not yet recruiting NCT05747131 - Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children N/A
Not yet recruiting NCT05225701 - Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders. N/A
Completed NCT02579915 - Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC) N/A
Recruiting NCT02376959 - Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers N/A
Recruiting NCT02186366 - Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type N/A
Not yet recruiting NCT02126787 - Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment N/A
Completed NCT02134730 - School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial N/A
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT01333098 - Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders Phase 1/Phase 2