Neurostimulation versus therapy for problems with emotions

Purpose of this Study

We are doing this study to find out if combining psychological skills and a procedure called neurostimulation during one clinic session can help reduce negative emotions and problems with dealing with emotions in both a laboratory setting and in a person's everyday life.

Who Can Participate?

Eligibility

Adults ages 18-55 who:
  • Identify as having difficulties managing their emotions (i.e., feeling like they get upset, irritated, angry, or anxious easily and they don't know what to do to feel better and/or their emotions are very overwhelming)
  • Are willing and able to come to Duke for the in-person study visits
  • Are able to complete 2 brain MRIs
  • Are either not in therapy currently or have been in the same type of therapy for at least 1 month before joining the study
  • Do not plan to start any new medications used for mood, stress, or sleep and will be able to stay on their same dose if they already use one of these medications
  • No significant brain history like stroke, lesions, mini-stroke, significant concussion, memory loss, seizures, or epilepsy
For more information about who can be in this study, please contact the study team at zoe.brasher@duke.edu.

Age Range

18-55

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will have 5 visits with our study team. Two visits will involve getting an MRI scan, and one visit will involve neurostimulation. The study will last for 2-3 months. You will attend the first study visit remotely (online). We will interview you and ask you to fill out some questionnaires. If you are eligible to join based on your answers, you will do the following:
  • Complete a short cognitive task that involves working with numbers.
  • Describe several recent stressful experiences and write them down.
  • Review your list of experiences with the study team and rate how stressful each event was.
We will schedule you to come to our clinic to have a brain MRI after the first visit. During the MRI, we will ask you to remember some of the negative memories you talked to us about during the first visit. At the next visit after your MRI, you will get a random assignment (like a coin flip) to receive one of two types of neurostimulation over the right side of your brain. The difference in the type of neurostimulation you get will be the configuration that we use for the neurostimulation machine. The type of neurostimulation being used in the study is called repetitive transcranial magnetic stimulation [rTMS] which involves placing an electromagnetic coil over your scalp that produces very small electric currents in the part of the brain closest to the coil. During your neurostimulation visit, you will get another random assignment (50:50 chance) for psychological skills training during this same visit. The 2 different skills groups are:
  • Skills Group 1: Thinking differently when upset
  • Skills Group 2: Improving awareness of emotions and regulation
At the end of this visit, we will schedule you to come in for a post-intervention brain MRI and to answer similar questionnaires that you did at the first visit. Your final visit will be about 1 month after your second MRI. This visit includes questionnaires, an interview, and a short behavioral task using one of your personalized stressors. Finally, we will ask for your feedback about the study and we will let you know what type of neurostimulation you got in the study. You can get in touch with us and take a preliminary eligibility survey for the study online: Study Eligibility Survey

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Study Website

Study Website

Principal Investigator

Andrada
Neacsiu

Protocol Number

PRO00111390

NCT ID

NCT05712057

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov