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Decision-Making Activities for Binge Eating Disorder
N/A
Recruiting
Led By Kristin N Javaras, DPhil, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal or corrected to normal vision and hearing
Be between 18 and 65 years old
Must not have
Certain medications (e.g., insulin)
Impaired cognition or other neurological/cognitive problems
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying women with and without binge-eating disorder to learn more about their brain activity during everyday decision-making.
Who is the study for?
This trial is for right-handed, young adult women with normal vision and hearing who are fluent in English. It's specifically for those with a BMI of 20-35 kg/m^2 and diagnosed with binge-eating disorder according to DSM-5 criteria. Women without eating disorders can also participate but must not have a personal or family history of such conditions.
What is being tested?
The study examines brain activity during everyday decision-making tasks like shopping choices or planning leisure activities. Researchers aim to understand the differences between women with and without binge-eating disorder when they make these daily decisions.
What are the potential side effects?
Since this trial involves talking and speaking activities rather than medical interventions, traditional side effects associated with medications are not expected. However, participants may experience stress or discomfort while discussing their habits or undergoing MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vision and hearing are normal, or corrected to be normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking insulin.
Select...
I have problems with my memory or thinking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 hour post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decision-making behavior (actual decisions)
Decision-related BOLD activation (executive function regions-of-interest)
Decision-related BOLD activation (reward regions-of-interest)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Talking Activity and Speaking ActivityExperimental Treatment2 Interventions
Participants will engage in a talking activity first and a speaking activity second.
Group II: Speaking Activity and Talking ActivityExperimental Treatment2 Interventions
Participants will engage in a speaking activity first and a talking activity second.
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,339 Total Patients Enrolled
Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,793 Total Patients Enrolled
Kristin N Javaras, DPhil, PhDPrincipal InvestigatorMclean Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previous experience participating in similar research studies.Your body mass index (BMI) falls between 20 and 35, which means you are within a healthy weight range.I have recently changed my mental illness treatment.I am taking insulin.You have a history of eating disorders or frequently overeating in a way that feels out of control.If someone in your immediate family has or had an eating disorder or a mental disorder, you cannot participate in the study as a comparison participant.You have very strict dietary restrictions or severe food allergies that may affect your ability to participate in the study.You currently use or have recently used recreational drugs often, or you used them frequently when you were younger.My vision and hearing are normal, or corrected to be normal.You have experienced thoughts of self-harm or suicide recently.You have a history of other mental illnesses or serious problems with substance use.I have been diagnosed with binge-eating disorder.You have a mental illness or substance use problem that would make it difficult for you to participate in the study or could potentially be unsafe for you.You have recently had an eating disorder like anorexia, avoidant-restrictive food intake disorder, or bulimia.I do not have any serious or unstable health conditions.I have recently lost weight.I have problems with my memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Talking Activity and Speaking Activity
- Group 2: Speaking Activity and Talking Activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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