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

Primary Purpose

Binge-Eating Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speaking Activity
Talking Activity
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Binge-Eating Disorder focused on measuring Binge-Eating Disorder, Decision-Making, Brain Activity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Speaking Activity and Talking Activity

Talking Activity and Speaking Activity

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2019
Last Updated
October 17, 2023
Sponsor
Mclean Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04125589
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
Keywords
Binge-Eating Disorder, Decision-Making, Brain Activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speaking Activity and Talking Activity
Arm Type
Experimental
Arm Description
Participants will engage in a speaking activity first and a talking activity second.
Arm Title
Talking Activity and Speaking Activity
Arm Type
Experimental
Arm Description
Participants will engage in a talking activity first and a speaking activity second.
Intervention Type
Behavioral
Intervention Name(s)
Speaking Activity
Intervention Description
Participants will engage in a speaking activity where they are given a topic to speak about.
Intervention Type
Behavioral
Intervention Name(s)
Talking Activity
Intervention Description
Participants will engage in a talking activity where they may talk about a topic of their choice.
Primary Outcome Measure Information:
Title
Decision-making behavior (actual decisions)
Description
Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)
Time Frame
Up to 1 hour post-intervention
Title
Decision-related BOLD activation (reward regions-of-interest)
Description
Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)
Time Frame
Up to 1 hour post-intervention
Title
Decision-related BOLD activation (executive function regions-of-interest)
Description
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)
Time Frame
Up to 1 hour post-intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Subjects must identify as female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Research Assistant
Phone
617-855-4080
Email
McLeanDecisionMakingStudy@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin N Javaras, DPhil, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin N Javaras, DPhil, PhD
Phone
617-855-2302
Email
kjavaras@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kristin N Javaras, DPhil, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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