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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Binge-Eating Disorder

Treatments

Behavioral: Speaking Activity
Behavioral: Talking Activity

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04125589
K23DK120517 (U.S. NIH Grant/Contract)
2018P001468

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

77 participants in 2 patient groups

Speaking Activity and Talking Activity
Experimental group
Description:
Participants will engage in a speaking activity first and a talking activity second.
Treatment:
Behavioral: Talking Activity
Behavioral: Speaking Activity
Talking Activity and Speaking Activity
Experimental group
Description:
Participants will engage in a talking activity first and a speaking activity second.
Treatment:
Behavioral: Talking Activity
Behavioral: Speaking Activity

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Study Research Assistant

Data sourced from clinicaltrials.gov

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