Neurostimulation and CBT

Neuromodulation-Enhanced Cognitive Restructuring

Duke eIRB # Pro00066383

Thank you for your interest in our Brain Stimulation and Cognitive Restructuring study! If you would like to participate in the screening to see if you may be eligible, please click here https://duke.qualtrics.com/SE/?SID=SV_7UuzFY6pHa9FdEF or read below for more information.

You might be eligible for this study if you:

• Are between 18-65 years old • Are not currently seeing a psychiatrist, psychologist, therapist, or other mental healthcare provider for psychotherapy services

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 emotional experience. We are testing the combination of two successful interventions (noninvasive brain stimulation and cognitive therapy) 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 and in the natural environment, both immediately after the intervention and a month later. The overall length of time you would be in the study ranges from 1 visit to 2 months, and involves coming to Duke for 3 or 4 appointments. Two of the appointments are long (3-4 hours), while the others will take less than an hour. You will be paid between $25 - $150, 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 https://duke.qualtrics.com/SE/?SID=SV_7UuzFY6pHa9FdEF, you will be contacted by phone by one of our study staff. If you are eligible for the study based on the online survey, we’ll set up an assessment appointment for you in our clinic at Duke. When you come to Duke for 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 4 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.

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 $10 plus a parking pass or bus pass to cover your transportation. If it is a good fit, an interviewer will ask you to describe in detail several stressful experiences you have had over the past few weeks. You will also be asked to write them down, review them with the interviewer, and rate how stressful they are for you. You will then be asked to return to the research office to begin the study that week if possible. When you come back to do the study you will have a brief medical exam and will provide a urine sample for a pregnancy test, both procedures intended to assess whether it is safe to administer repetitive neurostimulation to your brain. If you are not pregnant and pass the medical screen, we will then teach you how to think differently in emotional situation so it’s easier to calm down. This is called cognitive restructuring). We will practice on several scenarios until you and the intervention provider are confident that you understood the skill. We will then identify the dose of neurostimulation that is safe for you using a standardized procedure, and will expose you to either real or sham repetitive stimulation for 10 minutes to get you used to brain stimulation. You will not know whether you are receiving real or sham stimulation; this will depend on the condition you were randomly assigned to. Next, you will hear your stressful situations played back to you using headphones and will be prompted to use cognitive restructuring to feel better while concurrently receiving real or sham stimulation. You will be asked to answer questions on your cell phone for 1 week following the intervention. These questions will assess how emotionally distressed you feel in your daily life.

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; however, if we find that the study is not a good match for you, all identifying information such as your name and phone number will be destroyed and your data stored in a way that does not identify you. Only your answers to the questions, without your identifying data, will be used for research studies. This data will be kept indefinitely. Click here https://duke.qualtrics.com/SE/?SID=SV_7UuzFY6pHa9FdEF 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) 684-6714.

If you have any questions about participating in this study please contact Andrada D. Neacsiu, PhD at 684-6714 or email her at andrada.neacsiu@ duke.edu.

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