Clinical trial NCT04532242: Investigating the Neural Systems That Support the Reappraisal Tactics Leading to Positive Emotion
Official title: Investigating the Neural Systems That Support the Reappraisal Tactics Leading to Positive Emotion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior
Keywords: cognitive reappraisal
cognition
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: Wake Forest University
First posted: 2020-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Community members ages 18-55
* Fluent in English
* Without present psychotic symptoms

Exclusion Criteria:

* None

Primary outcomes:
measure: Self-reported emotion ratings
timeFrame: During the task intervention which will last 50 minutes
measure: Whole brain BOLD signal
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Mood ratings
timeFrame: Pre-intervention and immediately after the intervention
measure: Task difficulty
timeFrame: Immediately after the intervention
measure: Task compliance
timeFrame: Immediately after intervention
measure: Experience with task images
timeFrame: Immediately after intervention
Other outcomes:
measure: Depression trait differences
timeFrame: Baseline
measure: Emotional regulation trait differences
timeFrame: Baseline
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
Study officials:
affiliation: University of Denver
name: Kateri McRae, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: