Clinical trial NCT04125589: Decision Making, Daily Experiences, and Brain Activity in Young Adult Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Binge-Eating Disorder
Decision-Making
Brain Activity
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Decision-making behavior (actual decisions)
timeFrame: Up to 1 hour post-intervention
measure: Decision-related BOLD activation (reward regions-of-interest)
timeFrame: Up to 1 hour post-intervention
measure: Decision-related BOLD activation (executive function regions-of-interest)
timeFrame: Up to 1 hour post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Kristin N Javaras, DPhil, PhD
role: PRINCIPAL_INVESTIGATOR
References: