Thank you for your interest in our study! If you would like to see if you may be eligible, please click here or read below for more information.
You might be eligible for this study if you:
- Are between 18-55 years old
- Are either not currently seeing a mental healthcare provider for psychotherapy OR in stable talk therapy with no plans to change while in the study.
Here are some further details about the study that may interest you:
This is a study about identifying novel interventions to help those who have difficulty managing their emotional experiences. We are testing the combination of two interventions (noninvasive brain stimulation and behavioral skills training) aimed to help adults in one session calm down easier after they become emotionally distressed. We are interested in the effects of this intervention on ability to manage emotions and general distress in the lab immediately after the intervention. The overall length of time you would be in the study ranges from 1 visit to 2-3 months, and involves 5 study visits. One of the appointments (the first initial assessment visit) can be completed remotely. You will be paid depending on your time and participation in different parts of the study. You may have to wait until the end of the study to be paid.
Here’s how the process goes:
Once you complete the online survey by clicking this link, you will be contacted by phone by one of our study staff. If you are eligible for the study, we’ll set up a remote assessment appointment for you. If you prefer to do the first visit in person, we can plan to do that instead. At the assessment, you will receive a full description of the study and choose whether or not you would like to consent to participate. If you do agree to participate, you will fill out questionnaires and speak with an interviewer. This assessment day will last between 1 and 5 hours. The interviewer will ask you about many aspects of your life, including how you cope with stress, ways in which you tend to think about yourself, and how you get along with others. We will also ask questions about your personality, intelligence, and specific mental health problems such as anxiety and depression, motivation and interest, and sleep.
Based on that interview, we’ll make the final decision about whether or not this study is a good fit for you. If you are not eligible for the study, you will receive $20 plus a parking pass or bus pass to cover your transportation. If it is a good fit, an interviewer will ask you to a complete a short cognitive task that involves working with numbers and asking you to complete the task while being timed. You will then be asked to describe in detail several stressful experiences you have had over the past few weeks and in your lifetime. You will also be asked to complete them electronically online, review them with the interviewer, and rate how stressful they are for you.
If it is looking like the study is a good fit, you will then be scheduled a brain imaging session (MRI) at Duke. After the MRI, if you qualify, you will be randomly assigned (like a coin toss) to learn one of two psychological skills. Both skills (thinking differently when upset or improving awareness of emotions and regulation) have evidence of being effective. You will also randomly be assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS), the difference in the type of neurostimulation being the setup that we use for the neurostimulation machine.
You will then be asked to return to the research office for the intervention procedure. We will then identify the dose of rTMS that is safe for you using a standardized procedure, and will expose you to one of two types of rTMS over the right side of your brain for 10 minutes to get you used to brain stimulation. Next, you will hear your stressful situations played back to you using headphones and depending on the group you are in you will be prompted to use the psychological skill you were taught as you listen to 3 of your personal stressors.
All participants will then be scheduled for a second MRI, ideally within 1 week after your neurostimulation session where you will first complete a behavioral task listening to one of your general stressors as you again practice the psychological skill you were taught. You will then have the final MRI and complete questionnaires similar to the ones you completed at your first visit. Finally, after this visit, you will be asked to return for a 1 month follow-up visit. This will be your final study visit and you will undergo 1 last behavioral task practicing the skill as you listen to your last stressor, complete a final interview checking in on any psychological problems you had reported at the first visit as well as providing your feedback on your experience in the study. You will do questionnaires one last time.
If you choose not to answer any questions in the online survey, this will not affect your access to current or future health care at Duke, however you will not be able to participate in the study. Your research data (answers to the online survey questions) will not be stored or be connected to any of your Duke University Health Care information. We will keep the answers to all of these screening questions as part of our research. We will destroy all identifying information such as your name and phone number at the end of the study. Only your answers to the questions, without your identifying data, will be used for research studies. This data will be kept indefinitely.
Click here to begin the online survey for the Neurostimulation and Cognitive Restructuring study:
Note: If you do not have regular access to a computer or you would prefer to do these questions over the phone with one of our study staff, you may contact us directly at (919) 684-6785.
If you have any questions about participating in this study please contact Zoe Brasher at 919-684-6785 or email her at zoe.brasher@duke.edu.
Duke IRB # Pro00111390