Negative Affect Task for Binge Eating Disorder

GK
ME
Overseen ByMegan E Shott, BS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the link between negative feelings and binge eating in conditions like binge eating disorder (BED) and bulimia nervosa (BN). Researchers are investigating whether these feelings connect to changes in brain functions related to reward and control, potentially leading to new treatments. Participants who frequently experience binge eating episodes, feel distressed about it, or use compensatory behaviors like self-induced vomiting might be suitable candidates. The study also seeks to understand how these brain changes might increase vulnerability to binge eating. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new insights and treatments for binge eating disorders.

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.

What prior data suggests that the Negative Affect Task is safe for participants?

Research has shown that the Negative Affect Task is being studied as a potential treatment for binge-eating disorders, but there is limited direct information about its safety. Most studies focus on understanding binge-eating behaviors rather than specifically assessing the safety of this task.

As a behavioral treatment, it is generally considered low-risk compared to medication. Behavioral tasks like the Negative Affect Task usually involve activities or exercises designed to change certain behaviors or thought patterns. These tasks are typically non-invasive, meaning they don't involve surgery or drugs.

Participants in similar behavioral studies often report mild discomfort, mainly because the tasks might evoke negative emotions or thoughts. However, there have been no reports of serious issues directly caused by this task. If approved, any potential risks are expected to be minimal and will be closely monitored by the researchers.12345

Why are researchers excited about this trial?

The Negative Affect Task is unique because it addresses binge eating disorder by focusing on emotional triggers rather than just dietary habits. Traditional treatments for binge eating, like cognitive-behavioral therapy and medications such as antidepressants, often focus on altering behavior or chemical imbalances. However, this task aims to help individuals better understand and manage the negative emotions that can lead to binge eating episodes. Researchers are excited about this approach because it could offer a more personalized way to prevent binge eating by directly tackling the emotional aspects that are often overlooked in other treatments.

What evidence suggests that the Negative Affect Task is effective for binge eating disorder?

Research has shown that feeling sad or upset often precedes binge-eating episodes in individuals with binge-eating disorder (BED) and bulimia nervosa (BN). Studies have found that people with BED often struggle with problem-solving and decision-making tasks when in a negative mood, suggesting their brains might process emotions and rewards differently. One study found that training to improve self-control can help reduce the urge to eat when tempted by food. These findings suggest that managing negative emotions and enhancing self-control might help manage binge-eating behaviors. Participants in this trial will engage in the Negative Affect Task to explore these aspects further.678910

Who Is on the Research Team?

GK

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
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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?
1Treatment groups
Experimental Treatment
Group I: BehavioralExperimental Treatment1 Intervention

Find a Clinic Near You

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

Negative affect and binge eating: Assessing the unique ...This study examined the moderating effect of diagnosis on the trajectory of negative affect before and after binge eating.
Negative mood induction effects on problem-solving task in ...After a negative mood induction, women with BED provided significantly less effective problem-solving strategies compared to HCs and women with BN for the binge ...
Dysfunctional decision-making in binge-eating disorderThis yielded 50 studies reporting behavioural cognitive tasks outcomes, comparing individuals with BED to controls with normal and higher weight. Meta-analyses ...
The effects of response inhibition training following binge ...Response inhibition training may improve food-specific inhibitory control and reduce cue-induced motor activation by overriding prepotent 'cue → ...
Testing if Reductions in Negative Affect Yield Decreased ...The purpose of this study to test a computerized treatment designed to help people with high levels of emotional eating, which is when people eat to cope ...
Safety Behaviors Exacerbate Eating Disorder Fears - PMCThe present study tested to what extent eating disorder safety behaviors increase threat perception in individuals with and without an eating disorder.
Loss of control over eating: A systematic review of task ...Self-report measures show enhanced impulsivity and compulsivity in binge eating. ... Findings on behavioral impulsivity in binge eating are inconsistent.
The Role of Negative Affect in Emotional Processing ...The aim of the present study was to analyze differences in the emotional processing (valence, arousal, and dominance) of food-related information in patients ...
Binge eating disorder - PMC - PubMed CentralThe emotion regulation model outlines the role of negative affect as trigger for binge eating, whereas the interpersonal model suggests that interpersonal ...
Physical and mental health outcomes of an integrated ...A longitudinal study from the USA found a high rate (25.3%) of disordered eating behaviours (binge eating or unhealthy weight control) in young ...
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