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Completed

NCT Number: NCT04125589

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speaking Activity

Behavioral

Participants will engage in a speaking activity where they are given a topic to speak about.

Talking Activity

Behavioral

Participants will engage in a talking activity where they may talk about a topic of their choice.

Primary outcomes

  1. Decision-making behavior (actual decisions)

    Time frame: Up to 1 hour post-intervention

    Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)

  2. Decision-related BOLD activation (reward regions-of-interest)

    Time frame: Up to 1 hour post-intervention

    Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)

  3. Decision-related BOLD activation (executive function regions-of-interest)

    Time frame: Up to 1 hour post-intervention

    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)

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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