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

NCT ID: NCT04125589

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2025-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Binge-Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Speaking Activity and Talking Activity

Participants will engage in a speaking activity first and a talking activity second.

Group Type EXPERIMENTAL

Speaking Activity

Intervention Type BEHAVIORAL

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

Talking Activity

Intervention Type BEHAVIORAL

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

Talking Activity and Speaking Activity

Participants will engage in a talking activity first and a speaking activity second.

Group Type EXPERIMENTAL

Speaking Activity

Intervention Type BEHAVIORAL

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

Talking Activity

Intervention Type BEHAVIORAL

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

Interventions

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Speaking Activity

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

Intervention Type BEHAVIORAL

Talking Activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


• DSM-5 binge-eating disorder

Exclusion Criteria

* 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


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristin Nicole Javaras

Assistant Psychologist, Division of Women's Mental Health, McLean Hospital; Assistant Professor of Psychology, Department of Psychiatry, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin N Javaras, DPhil, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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K23DK120517

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018P001468

Identifier Type: -

Identifier Source: org_study_id

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