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Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Zoe Brasher
zoe.brasher@duke.edu
9196846785
Backup
Lisalynn D Kelley, CCRP
lisalynn.kelley@duke.edu
9196846701
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 240
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov