Binge-Eating DisorderNCT04125589
Decision Making, Daily Experiences, and Brain Activity in Young Adult Women
A study testing Speaking Activity and Talking Activity in people with Binge-Eating Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Speaking Activity and Talking Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2019to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Binge-Eating Disorder
- Being tested
- Speaking Activity, Talking Activity
- Keywords
- Binge-Eating Disorder, Decision-Making, Brain Activity
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speaking ActivityBehavioural
Participants will engage in a speaking activity where they are given a topic to speak about.
Talking ActivityBehavioural
Participants will engage in a talking activity where they may talk about a topic of their choice.
| Study group | Role | What they receive |
|---|---|---|
| Speaking Activity and Talking Activity | Experimental | Participants will engage in a speaking activity first and a talking activity second. Receives: Behavioral: Speaking Activity; Behavioral: Talking Activity |
| Talking Activity and Speaking Activity | Experimental | Participants will engage in a talking activity first and a speaking activity second. Receives: Behavioral: Speaking Activity; Behavioral: Talking Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision-making behavior (actual decisions)
Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)
Measured: Up to 1 hour post-intervention
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)
Measured: Up to 1 hour post-intervention
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)
Measured: Up to 1 hour post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start31 Dec 2019
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Nicole Javaras, Mclean Hospital
- Investigators
- Kristin N Javaras, DPhil, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125589
- Sponsor's protocol ID
- 2018P001468
- Other IDs
- K23DK120517
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04125589
- Acronym / sponsor ID
- 2018P001468
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge-Eating Disorder, Decision-Making, Brain Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speaking Activity and Talking Activity | Experimental | Behavioral: Speaking Activity, Behavioral: Talking ActivityParticipants will engage in a speaking activity first and a talking activity second. |
| Talking Activity and Speaking Activity | Experimental | Behavioral: Speaking Activity, Behavioral: Talking ActivityParticipants will engage in a talking activity first and a speaking activity second. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speaking ActivityParticipants will engage in a speaking activity where they are given a topic to speak about. | Behavioural | Speaking Activity and Talking Activity, Talking Activity and Speaking Activity |
| Talking ActivityParticipants will engage in a talking activity where they may talk about a topic of their choice. | Behavioural | Speaking Activity and Talking Activity, Talking Activity and Speaking Activity |
Primary outcome
Decision-making behavior (actual decisions)
Time frame: Up to 1 hour post-intervention
Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)
Decision-related BOLD activation (reward regions-of-interest)
Time frame: Up to 1 hour post-intervention
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)
Time frame: Up to 1 hour post-intervention
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin N Javaras, DPhil, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speaking Activity and Talking Activity in people with Binge-Eating Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision-making behavior (actual decisions) (time frame: Up to 1 hour post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.