RECRUITING

Neurostimulation Versus Therapy for Problems With Emotions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-15

Study Completion:2027-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05712057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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, * 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 lesion, 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, 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)

Inclusion Criteria

Exclusion Criteria

* 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

* 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,
* 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 lesion, 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, 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)

Contacts and Locations

Study Contact

Zoe Brasher

CONTACT

9196846785

zoe.brasher@duke.edu

Lisalynn D Kelley, CCRP

CONTACT

9196846701

lisalynn.kelley@duke.edu

Principal Investigator

Andrada D Neacsiu, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Andrada D Neacsiu, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-15

Study Completion Date2027-07-01

Study Record Updates