Clinical trial NCT03978871: Effect of Emotion Mindsets on Emotion Processing
Official title: Effect of Emotion Mindsets on Emotion Processing: A Multilevel Experimental Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotions
Keywords: Brain
Functional Neuroimaging
Stress, Psychological
Emotions
Psychology, Developmental
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Auburn University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-06-07
Enrollment: 163
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The guiding scientific premise for this research is that a growth emotion mindset will promote more adaptive emotion processing than a fixed emotion mindset. Because emotional sensitivity is particularly salient in adolescent girls, we will focus on this group. Using an experimental design, adolescent girls will be randomly assigned to either a mindset manipulation or a control group (brain education). Each group will complete a 25-minute computer-based lesson followed by a social stressor and a functional magnetic resonance imaging session. Two specific aims will be addressed: (1) to determine whether a growth mindset induction, relative to a control condition, predicts more adaptive emotion processing at the neural, behavioral, and psychological levels of processing; and (2) to determine whether neural processing of emotion accounts for the effect of a growth emotion mindset manipulation on behavioral and psychological processing of emotion. This study builds on a strong empirical database establishing the effect of mindsets on multiple domains of functioning but will be the first to examine the implications of a growth vs. fixed mindset about emotion for emotion processing in adolescent girls, thereby elucidating one specific youth attribute that can support or disrupt emotional development.

Detailed description: 150 adolescent girls will complete baseline measures and then be randomly assigned to one of two conditions and will complete a computer-based lesson (see below). Girls will then engage in a social stressor outside of the scanner as well as an emotional challenge and cognitive control task in the scanner and will complete post-scan measures. Two and four months after the scan session they will complete additional survey measures.

Experimental condition: The (Growth Emotion Mindset) GEM manipulation, involves 6 components: (1) Introduction: discussion of emotional experiences in teenagers; (2) Explanation of neuroplasticity, emphasizing the potential for changes in the brain and modification of emotions during adolescence; (3) Scientific evidence for the effect of emotion regulation training on mood improvement; (4) Brief factual quizzes and written summary of key points; (5) Scenarios in which older youth describe challenging situations when they used growth mindsets to help regulate negative emotions; and (6) Self-persuasion exercise: a. Girls read a hypothetical scenario about an emotional challenge and describe their likely thoughts and feelings; b. Girls imagine the same event happening to another (younger) teen and help them understand how they can change, integrating what they learned about malleability of the brain and emotion.

Control condition: The control condition involves a structurally similar session, with the same number and type of reading and writing activities, that focuses on general education about the brain.

Social stressor. Using an adapted version of the Trier Social Stressor Test, girls will prepare a speech in which they convince a group of peers (who ostensibly will watch a video of the speech; in reality, there are no peers) that they should be selected for a fictional television show about teens' ability to form friendships. Girls face a computer screen displaying their image while preparing and presenting a speech. At intervals of 20 seconds, a female evaluator will mark a clipboard. Before and after the Trier, girls will rate several dimensions of state negative affect. After the Trier, girls will rate their use of in vivo emotion regulation strategies.

Girls will then undergo scanner training and watch a neutral video during an anatomical scan.

Emotional challenge (Social Evaluation Task). Girls will watch validated videos created for functional magnetic resonance imaging, which depict females making one of three types of statements with matching affective expression: negative social-evaluative, positive social-evaluative, or neutral. Before each video, girls will receive a prompt instructing them to imagine how they would feel if the female were a friend and if the statement was directed either toward the participant (immerse), or toward a stranger (reframe). After the cue, there will be a pause, presentation of the video, and another pause. After each trial, the participant will rate how bad they feel on a 5-point scale.

Resting state. Following the emotional challenge, girls will remain still and fixate on a central cross. Greater ability to flexibly engage and disengage emotion regulation in response to changing external challenges (imposed by negative, positive, and neutral videos) is expected to be reflected in the functional connectome for minutes beyond the emotional challenge task, resulting in more within-network connectivity in cognitive control networks as well as increased connectivity with emotion regions in girls engaged in proactive emotion regulation.

Emotional go-nogo. This task combines a cognitive control task (go-nogo) with emotion distractors depicting negative (social rejection), positive (social acceptance), or neutral (scrambled) images taken from a validated set of stimuli. Letters are presented sequentially in a small box at the center of the screen, with emotion distractors in the background. The distractors are presented alone , prior to presentation of the letter, to make it difficult to ignore the emotional content. Girls are instructed to ignore the images and respond as quickly as possible without sacrificing accuracy with a button press to every letter (go trials), except for Xs (no-go; 25 percent of trials). Girls acquire a prepotent tendency to press and must inhibit their responses during X trials.

Edited June 2020:

Anticipated 75% and 100% enrollment dates as well as primary and final study completion dates and primary endpoint analyses and reporting of results were changed due to recruitment and data collection obstacles posed by the coronavirus pandemic. The new dates were estimated based on the assumption that some recruitment and data collection will resume in the fall of 2020. If this is not possible or if families are reluctant to complete sessions, completion dates may need to be changed again at a later date.

Edited November 2021:

Although the 75% enrollment was reached, anticipated 100% enrollment date as well as primary and final study completion dates and primary endpoint analyses and reporting of results were changed due to ongoing recruitment and data collection obstacles posed by the coronavirus pandemic. Although a small amount of recruitment and data collection resumed fall of 2020-fall of 2021, obstacles still remain due to school and family reluctance to participate in research.

Eligibility criteria: Inclusion Criteria:

* Female age 13-18 years old
* Over-sample (approximately 1/3 of sample) for score \>= .75 standard deviation (SD) on a screening measure of fixed mindset about emotion
* English-speaking
* Ability to independently complete tasks and measures

Exclusion Criteria:

* History of surgery involving metal implants
* Possible metal fragments in the eyes or other parts of body
* Pacemaker
* A history of claustrophobia
* Braces
* Weighing over 250 pounds
* Pregnancy or possibility of being pregnant
* Severe medical conditions (e.g., blind or deaf, head trauma)
* Learning disability or other condition that interferes with ability to complete tasks

Primary outcomes:
measure: Mean Change From Pre to Post Mindset Manipulation on Emotion Mindset Scale (Measures Beliefs About Whether Emotions Are Fixed or Malleable)
timeFrame: Pre vs. Post Mindset Manipulation: baseline
measure: Mean Change From Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale (Measure Beliefs About Ability to Control Emotions)
timeFrame: Pre vs. Post Mindset Manipulation: baseline
measure: Mean Change From Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes (Measure Beliefs About Ability to Control Emotions in Specific Situations)
timeFrame: Pre vs. Post Mindset Manipulation: baseline
measure: Mean Difference in Performance on Go/Nogo Task- Reaction Time
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Performance on Go/Nogo Task- Accuracy
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Emotion Regulation Strategies on the Emotion Regulation Strategy Scale
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Amygdala Activation- Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Amygdala Activation- Go/No-go Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Frontal Parietal Network-Amygdala Connectivity- Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Frontal Parietal Network-Amygdala Connectivity- Go/No-go Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Change on Self-Reported State Negative Affect
timeFrame: Pre-Trier vs. Post-Trier: baseline
measure: Mean Difference on Self-Reported Affect on Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
Secondary outcomes:
measure: Mean Change From Baseline to 2 Months in Emotion Mindset Scale Scores
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Emotion Mindset Scores
timeFrame: At baseline and in approximately 4 months
measure: Mean Change From Baseline to 2 Months in Emotional Self-efficacy Scale Scores (Measure Beliefs About Ability to Control Emotions)
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Emotional Self-efficacy Scale Scores (Measure Beliefs About Ability to Control Emotions)
timeFrame: At baseline and in approximately 4 months
measure: Mean Change From Baseline to 2 Months in Emotional Self-efficacy Vignettes Scores
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Emotional Self-efficacy Vignettes Scores
timeFrame: At baseline and in approximately 4 months
measure: Mean Change From Baseline to 2 Months in Self-Reported Emotion Regulation Strategies Scores
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Self-Reported Emotion Regulation Strategies Scores
timeFrame: At baseline and in approximately 4 months
Other outcomes:
measure: Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Go/No go Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Resting State
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal Cingulo-Opercular Network-Amygdala Connectivity- Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network-Amygdala Connectivity- Go/no go Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Difference in Parameter Estimates of BOLD Signal Cingulo-Opercular Network-Amygdala Connectivity- Resting State
timeFrame: Post Mindset Manipulation: baseline
measure: Group Differences in Parameter Estimates of BOLD Signal for Whole-Brain Analyses- Social Evaluation Task
timeFrame: Post Mindset Manipulation: baseline
measure: Mean Change From Baseline to 2 Months in Depressive Symptoms Scores
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Depressive Symptoms Scores
timeFrame: At baseline and in approximately 4 months
measure: Mean Change From Baseline to 2 Months in Anxiety Symptoms Scores
timeFrame: At baseline and in approximately 2 months
measure: Mean Change From Baseline to 4 Months in Anxiety Symptoms Scores
timeFrame: At baseline and in approximately 4 months
Locations:
city: Champaign
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois, Urbana Champaign
name: Karen D Rudolph, PhD
role: PRINCIPAL_INVESTIGATOR
References: