Decision Making, Daily Experiences, and Brain Activity in Young Adult Women

Binge-Eating Disorder Clinical Trial

Official title:

Understanding The Effects of Acute Stressors and Negative Emotion on Eating Behavior in Binge-Eating Disorder: The Role of Stressor-Induced Changes in Reward and Cognitive Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125589
• Other study ID #: 2018P001468
• Secondary ID: K23DK120517
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2019
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Mclean Hospital
• Contact: Study Research Assistant
• Phone: 617-855-4080
• Email: McLeanDecisionMakingStudy[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are doing a study of women with and without binge-eating disorder to learn more about what happens when people engage in everyday decision-making activities. The investigators are interested in learning more about brain activity during everyday decision-making and how everyday decision-making relates to a variety of daily experiences. Examples of everyday decisions include deciding which product to buy, deciding what to eat for a snack, and deciding how to spend free time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

INCLUSION CRITERIA:

Inclusion Criteria for All Participants:

• Normal or corrected to normal vision and hearing
• Verbal and written fluency in English
• Right-handed
• Body mass index of 20-35 kg/m^2

Additional Inclusion Criteria for Participants with Binge-Eating Disorder:

• DSM-5 binge-eating disorder EXCLUSION CRITERIA:

Exclusion Criteria for All Participants:

• Impaired cognition or other neurological/cognitive problems
• Contraindications to MRI (e.g., certain metal implants, claustrophobia)
• Currently/recently/potentially pregnant, seeking to become pregnant in the near future, or breastfeeding
• Serious and/or unstable medical diseases and conditions, and certain other medical diseases and conditions
• Recent low weight
• Certain medications (e.g., insulin)
• Current/recent frequent recreational drug use, or history of frequent recreational drug use in early adolescence
• Extreme dietary limitations (e.g., veganism), pervasive food allergies, or limited exposure to popular snack foods
• Current/recent suicidality
• Current/recent changes in treatment for mental illness
• Study-relevant research experience

Additional Exclusion Criteria for Comparison Participants:

• Personal history of eating disorders or recurrent binge eating
• Personal history of any other mental illness, including serious substance use problems
• First-degree relative with current or past eating or psychotic disorder
• Significant recent change in weight

Additional Exclusion Criteria for Participants with Binge-Eating Disorder:

• Severe mental illness (e.g., psychotic disorder, severe agoraphobia)
• Certain other current/recent mental illness, including severe substance use problems, that would limit study participation or safety
• Recent anorexia nervosa spectrum disorder, avoidant-restrictive food intake disorder, or bulimia nervosa spectrum disorder

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• Speaking Activity
Participants will engage in a speaking activity where they are given a topic to speak about.
• Talking Activity
Participants will engage in a talking activity where they may talk about a topic of their choice.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision-making behavior (actual decisions)	Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)	Up to 1 hour post-intervention
Primary	Decision-related BOLD activation (reward regions-of-interest)	Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)	Up to 1 hour post-intervention
Primary	Decision-related BOLD activation (executive function regions-of-interest)	Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in executive function (e.g., dorsolateral prefrontal cortex, inferior frontal gyrus)	Up to 1 hour post-intervention