Negative Affect Task for Binge Eating Disorder

Overseen By Megan E Shott, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Psychostimulants, others

Disqualifiers: Pregnancy, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

410 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Binge-eating is characterized by recurrent episodes of eating large amounts of - typically high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes. Two eating disorders are characterized by binge-eating as central diagnostic criteria, binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED is typically associated with obesity, while BN is not. Behavior studies such as ecological momentary assessment (EMA) research of affect in an individual's naturalistic environment have shown that negative affect and negative urgency (the tendency to act rashly when distressed) often precede binge-eating. The Investigators want to answer the following questions: Can negative affect in BN and BED be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value computation and cognitive control circuit function, and 3) can dopamine related brain activation predict eating and negative affect, indicating a brain based neurobiological vulnerability. Answering those questions will help to define binge-eating based on regulation of brain reward, cognition, and emotion circuit function and point toward potential psychopharmacological interventions to normalize brain function and behavior.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are on medications other than birth control pills (BCP) or intrauterine devices (IUD) for healthy controls and obese participants. For those with Binge Eating Disorder or Bulimia Nervosa, there is no mention of stopping current medications, but certain medications like psychostimulants are excluded.

How does the Negative Affect Task treatment differ from other treatments for binge eating disorder?

The Negative Affect Task treatment is unique because it focuses on understanding and modifying the emotional responses (negative feelings) that often precede binge eating episodes, rather than directly targeting eating behaviors. This approach is based on the idea that changes in emotions can influence binge eating, which is different from traditional treatments that may focus more on dietary changes or cognitive-behavioral strategies. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Negative Affect Task for Binge Eating Disorder?

Research suggests that changes in negative emotions (like stress or guilt) are linked to binge eating, and managing these emotions can help reduce binge episodes. The Negative Affect Task may help by addressing these emotional changes, as studies show that improvements in negative emotions can decrease binge eating behavior. ^{1 2 3 4 5}

Who Is on the Research Team?

Guido KW Frank, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Adults aged 18-55 with obesity (BMI > 30 kg/m2) and diagnosed with Bulimia Nervosa or Binge Eating Disorder, experiencing marked distress from binge eating. Participants should have a stable weight and food intake for the past month, no major medical illnesses, no history of substance abuse or certain psychiatric disorders, not pregnant or breastfeeding, and without metal implants.

Inclusion Criteria

I am 18-55 years old with Binge Eating Disorder and right-handed as per the EHI-R.

I am 18-55, have a healthy weight, regular menstrual cycles (if applicable), and am right-handed.

Exclusion Criteria

Obese: Current pregnancy or breast feeding within last 3 months, First degree relative with current or past eating disorder, Current or previous eating disorder diagnosis, Current Medications other than BCP or IUD, Past or present Axis I psychiatric disorder including substance or alcohol use disorder, Major Medical illness, Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence, Metal implants or braces

I am not pregnant, breastfeeding, on certain medications, have a psychiatric disorder, a major illness, substance abuse history, or metal implants.

Binge Eating Disorder: Pregnancy or breast feeding within last 3 months, Lifetime history of bipolar disorder or psychosis, Use of a psychostimulant within the prior 6 months, Recent history of substance abuse or dependence (except for alcohol and cannabis use), Major Medical illness, Metal implants or braces

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Task Phase

Participants undergo fMRI tasks to study brain activation in response to negative affect during taste reward and food choice paradigms

2 study days

2 visits (in-person)

Follow-up

Participants are monitored for brain activation and food intake/negative affect relationships over a long-term period

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Negative Affect Task

Trial Overview The trial is studying how negative emotions affect people with bulimia nervosa and binge eating disorder. It aims to link these feelings to brain function related to reward learning, food value computation, cognitive control circuits, and whether this can predict future eating behavior.

How Is the Trial Designed?

Group I: Behavioral Experimental Treatment 1 Intervention

Negative Affect Task

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Sanford Research

Collaborator

Trials

6

Recruited

1,200+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

The impact of neural responses to food cues following stress on trajectories of negative and positive affect and binge eating in daily life. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Beliefs about the emotional consequences of eating and binge eating frequency. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Examining intra-individual variability in food-related inhibitory control and negative affect as predictors of binge eating using ecological momentary assessment. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The role of affect in the maintenance of binge-eating disorder: Evidence from an ecological momentary assessment study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Eating expectancies and reinforcement learning: a state-based test of affect regulation and expectancy models in the natural environment. [2022]