- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03429114
Emotion Regulation in Binge Eating and Purging Among Adolescents
December 4, 2022 updated by: Cara Bohon, PhD, Stanford University
Neural Correlates of Emotion Regulation and Executive Function in Binge Eating and Purging Among Adolescents
The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents.
Furthermore, it will look at the influence of executive function on emotion regulation in this population.
This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group.
Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University, Department of Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female adolescents between ages 14-18.
Description
Inclusion Criteria:
- Female
- Ages 14-18
- with or without current binge eating and/or purging behaviors
Exclusion Criteria:
We exclude patients of clinically significant low weight (<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Binge eating/purging
Adolescents engaging in recurrent binge eating and/or purging behavior.
|
We will conduct MRI and fMRI brain scans to compare brain function between groups.
|
Healthy comparison
Adolescents who do not have a history of eating disorders
|
We will conduct MRI and fMRI brain scans to compare brain function between groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity during emotion conflict
Time Frame: Baseline
|
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants respond to images of faces with emotional expressions overlaid with an emotion word written in text.
We will focus on brain response during this task when emotion face vs word are in conflict.
|
Baseline
|
Brain activity during emotion regulation
Time Frame: Baseline
|
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants attempt to regulate emotional responses.
|
Baseline
|
Brain activity during cognitive control and emotion response
Time Frame: Baseline
|
Functional magnetic resonance imaging will be used to measure brain activity during a task where participants engage in cognitive control and respond to emotional stimuli.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral performance on emotion conflict task
Time Frame: Baseline
|
Response times will be used as behavioral measure on the emotion conflict task
|
Baseline
|
Behavioral performance on emotion regulation task
Time Frame: Baseline
|
Emotion ratings will be used as behavioral measure on the emotion regulation task
|
Baseline
|
Behavioral performance on cognitive control and emotion regulation task
Time Frame: Baseline
|
Emotion ratings will be used as behavioral measure on the cognitive control and emotion regulation task
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2017
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
February 2, 2018
First Submitted That Met QC Criteria
February 8, 2018
First Posted (Actual)
February 12, 2018
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 4, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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