NCT04532242

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 22, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

August 25, 2020

Last Update Submit

July 21, 2023

Conditions

Keywords

cognitive reappraisalcognition

Outcome Measures

Primary Outcomes (2)

  • Self-reported emotion ratings

    Participants will be rating their negative and positive emotions during the intervention. They will be asked "How positive do you feel?" and "How negative do you feel?" after each image and will answer on a scale of 1-9 with 1 being low ("I don't feel positive at all" or "I don't feel negative at all") to 9 ("I feel very positive" or "I feel very negative").

    During the task intervention which will last 50 minutes

  • Whole brain BOLD signal

    Changes in blood oxygen dependent level (EPI sequences) from the whole brain collected in a 3T MRI scanner with a head-coil specifically for fMRI.

    Immediately after the intervention

Secondary Outcomes (4)

  • Mood ratings

    Pre-intervention and immediately after the intervention

  • Task difficulty

    Immediately after the intervention

  • Task compliance

    Immediately after intervention

  • Experience with task images

    Immediately after intervention

Other Outcomes (2)

  • Depression trait differences

    Baseline

  • Emotional regulation trait differences

    Baseline

Study Arms (1)

fMRI Participants

EXPERIMENTAL

Participants will be scanned in an fMRI session lasting approximately 45-50 minutes and will be shown negative images for which they will have to take on a cognitive reappraisal tactic. All participants will be taken through the scanner with the same reappraisal protocol for each participant.

Behavioral: Cognitive reappraisal

Interventions

Participants will be trained to follow instructions to look/respond naturally or use cognitive reappraisal to reframe or reconsider a negative picture to decrease negative emotion.

fMRI Participants

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Denver

Denver, Colorado, 80208, United States

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

  • Kateri McRae, Ph.D.

    University of Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateri McRae, Ph.D.

CONTACT

Alyssa Asmar, B.A

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 31, 2020

Study Start

June 22, 2023

Primary Completion

August 31, 2023

Study Completion

November 1, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations