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Clinical Trial Summary

Community participants will visit the neuroimaging facilities at CU Boulder for a single experimental session. In all studies, participants will complete pre-task questionnaires (trait measures), and a brief mood measure, followed by a task training in which a research assistant describes and gives examples of cognitive reappraisal in response to negative images. Then, participants complete an event-related, picture-based cognitive reappraisal task for 30-45 minutes, during which whole-brain BOLD signal will be collected. Following the task, participants will once again respond to a mood measure, and answer a series of questions regarding the task they have completed, including difficulty of regulation, or any images that were personally relevant. The researchers predict that the positive emotion induction will result in powerful effects on self-reported emotion which may or may not interact with the cognitive reappraisal condition. Participants will be trained to use reappraisal to increase positive emotion, and they will be asked to respond with the reappraisal tactic category that best fits the reappraisal they used for each image. The researchers predict greater use of future-focused tactics will be associated with greater reappraisal success, which in turn will result in greater recruitment of vmPFC and connectivity between vmPFC and other prefrontal regions.


Clinical Trial Description

For all studies, participants will be recruited via paper and electronic flyers on campus and in the surrounding communities. Interested participants will be screened via phone, email and/or web form to assess eligibility according to criteria listed elsewhere. Should participants qualify, they will be invited to complete a single laboratory session at the Intermountain Neuroimaging Facility at CU Boulder. Participants will be sent a copy of the consent form to read in advance of their visit, and to keep for their records. Once arriving at the laboratory, participants will complete the consent process, in which a research assistant trained in ethical principles regarding human subjects research will answer any questions about the consent form and verbally reinforce the key rights of the participants outlined there. Once both parties are satisfied, consent forms will be signed. Participants will then complete a mandatory day-of MRI eligibility form to ensure scanner compatibility has not changed since the initial screening (done by phone, email or webform). Females who are unable to indicate "no" to the question, "is it possible that you are pregnant?" will be asked to take a pregnancy test provided at the MR facility. Participants will change into MRI- compatible clothes or scrubs. Participants will sit with a trained research assistant/experimenter who will give an overview of the entire session, and then begin training for the cognitive reappraisal task. This training takes 10-15 minutes. During the training, the experimenter will offer several possible reappraisals of negative images and allow the participants to offer their own as well, providing encouragement and feedback. During this training, the experimenter will also go over the method of encouragement and feedback. During this training, the experimenter will also go over the method of responding (using an external button box). Participants will be reminded during training that they may stop the experiment at any point if the pictures are too upsetting. Immediately following task training, participants will make a general mood rating using the PANAS. Then, participants will be screened one final time for metal in or near their bodies at the door to the shielded MRI room, then be placed in the MRI scanner by a certified, full-time MRI technician. Participants will be reminded they can stop the experiment at any point if they are physically uncomfortable or become claustrophobic, and will be outfitted with a panic button to indicate that they wish to stop the experiment immediately once it has begun. After the initial structural and calibration scans, participants will complete the reappraisal task. The task will take 40-50 minutes (broken up into 4-5 separate functional runs in the scanner, with each run taking around 10 minutes). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04532242
Study type Interventional
Source University of Denver
Contact Kateri McRae, Ph.D.
Phone 303-871-3632
Email Kateri.McRae@du.edu
Status Recruiting
Phase N/A
Start date June 22, 2023
Completion date November 1, 2023

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