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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Behavioral: Speaking Activity; Behavioral: Talking Activity

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Research Assistant; Phone Number: 617-855-4080; Email: McLeanDecisionMakingStudy@partners.org

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Contact: Kristin N Javaras, DPhil, PhD; Phone Number: 617-855-2302; Email: kjavaras@mclean.harvard.edu
      • Principal Investigator: Kristin N Javaras, DPhil, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Speaking Activity and Talking Activity; Participants will engage in a speaking activity first and a talking activity second.	Behavioral: Speaking Activity; Participants will engage in a speaking activity where they are given a topic to speak about.; Behavioral: Talking Activity; Participants will engage in a talking activity where they may talk about a topic of their choice.
Experimental: Talking Activity and Speaking Activity; Participants will engage in a talking activity first and a speaking activity second.	Behavioral: Speaking Activity; Participants will engage in a speaking activity where they are given a topic to speak about.; Behavioral: Talking Activity; Participants will engage in a talking activity where they may talk about a topic of their choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision-making behavior (actual decisions)	Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)	Up to 1 hour post-intervention
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
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

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kristin N Javaras, DPhil, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Brain Activity; Binge-Eating Disorder; Decision-Making
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: 2018P001468; K23DK120517 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No