Decision-Making Activities for Binge Eating Disorder

Overseen By Study Research Assistant

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Mclean Hospital

Must not be taking: Insulin

Disqualifiers: Neurological problems, Pregnancy, Drug use, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how women make everyday decisions and how these decisions relate to brain activity and daily experiences. The study involves speaking and talking activities to explore these decision-making processes. Women interested in joining should be fluent in English, right-handed, and have a body mass index (BMI) between 20 and 35. Researchers will compare participants with binge-eating disorder to those without to examine differences in decision-making between the groups. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding without the risks of testing new treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but certain medications like insulin are excluded. It's best to discuss your specific medications with the trial team.

What prior data suggests that these decision-making activities are safe?

Research shows that activities like speaking and talking are generally safe for participants. Studies commonly use these activities, which do not involve medication or physical procedures. The study aims to understand decision-making in everyday situations, focusing on observation and learning rather than testing a new drug or treatment.

The activities in this study resemble daily tasks, such as choosing what to buy or eat, resulting in minimal risk. Other studies have reported no negative effects from these types of activities. Therefore, participants can feel confident that these activities are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these activities because they explore novel ways to tackle binge eating disorder through communication-based techniques rather than medication or traditional therapy alone. Unlike conventional treatments like cognitive-behavioral therapy or pharmacotherapy, these activities focus on decision-making and self-reflection through structured talking and speaking exercises. By engaging participants in these activities, there is potential to enhance self-awareness and decision-making skills, offering a fresh approach to managing binge eating behaviors. This trial aims to uncover whether such interactive and engaging methods can effectively complement or even improve upon existing treatment strategies.

What evidence suggests that this trial's activities could be effective for decision-making in binge eating disorder?

Research has shown that talking activities can help manage binge eating disorder (BED) by addressing its mental aspects. In this trial, participants will engage in both talking and speaking activities, with sequences varying by treatment arm. Studies have found that methods like motivational interviewing effectively promote healthier choices in eating disorders. Motivational interviewing involves discussing options to boost motivation and commitment. Participating in these talking activities may change behaviors by increasing awareness and control over eating habits. These activities aim to improve decision-making, potentially reducing binge eating episodes. While specific data on this exact treatment is limited, existing research on behavior change in eating disorders supports its underlying concepts. ^{3 6 7 8 9}

Who Is on the Research Team?

Kristin N Javaras, DPhil, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your body mass index (BMI) falls between 20 and 35, which means you are within a healthy weight range.

Verbal and written fluency in English

My vision and hearing are normal, or corrected to be normal.

Exclusion Criteria

You have previous experience participating in similar research studies.

I have recently changed my mental illness treatment.

I am taking insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in talking and speaking activities to assess decision-making and brain activity

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for decision-related BOLD activation and decision-making behavior post-intervention

1 hour

What Are the Treatments Tested in This Trial?

Interventions

• Speaking Activity
• Talking Activity

Trial Overview

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.

How Is the Trial Designed?

Group I: Talking Activity and Speaking Activity Experimental Treatment 2 Interventions

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

Group II: Speaking Activity and Talking Activity Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Implementation intentions (IIs) significantly reduced binge eating in a student sample over a 4-week period, with effects lasting for 6 months, indicating their efficacy in changing eating behaviors.

There was no additional benefit from using mental imagery (MI) alongside IIs, suggesting that simply forming 'if-then' plans may be sufficient for achieving long-term reductions in binge eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of implementation intentions and mental imagery on subjective binge eating. Tanis, J., Vroling, MS., Maas, J., et al.[2023]

Patients with binge eating disorder (BED) exhibit heightened food-related impulsivity, which is linked to their binge eating episodes and loss of control over eating.

The antisaccade task can be modified to serve as a training tool for BED patients, helping them practice suppressing impulsive responses to food stimuli, potentially improving their control over eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antisaccadic training to improve impulsivity in binge eating disorder. Giel, KE., Schag, K., Plewnia, C., et al.[2018]

In a study involving 64 adolescents with binge-eating disorder (BED), cognitive-behavioral therapy (CBT) showed excellent therapist adherence and therapeutic alliance, which are crucial for effective treatment.

The study found that patient characteristics, such as treatment expectations and the frequency of loss of control eating episodes, significantly influenced adherence and alliance, highlighting the need for tailored supervision in CBT for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist adherence and therapeutic alliance in individual cognitive-behavioural therapy for adolescent binge-eating disorder. Puls, HC., Schmidt, R., Hilbert, A.[2019]

A study of 424 adults with binge-eating disorder (BED) revealed that these patients experience significant functional impairment and interpersonal issues compared to non-clinical norms, indicating a need for targeted treatment strategies.

Patients with BED showed a high level of motivation for treatment, characterized by low resistance to interventions and high subjective distress, suggesting that they may benefit from longer, more intensive, and interpersonally focused therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Approach to Clinical Decision-Making for Treating Patients With Binge-Eating Disorder. Chyurlia, L., Tasca, GA., Bissada, H.[2020]

The 8-session internet-based guided self-help program for binge-eating disorder (BED) was well-accepted by participants, leading to a significant reduction in weekly binge-eating episodes from an average of 3.4 to 1.7, with improvements maintained during a 6-month follow-up.

Despite a dropout rate of 27% during treatment, the program showed high treatment satisfaction, and the addition of positive expectation induction before treatment did not enhance the effectiveness of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BED-online: Acceptance and efficacy of an internet-based treatment for binge-eating disorder: A randomized clinical trial including waitlist conditions. Wyssen, A., Meyer, AH., Messerli-Bürgy, N., et al.[2022]

Female patients with binge eating disorder (BED) and obese women without BED showed poor decision-making abilities on the Iowa Gambling Task (IGT), indicating significant cognitive deficits in these groups.

Unlike normal weight women, those with BED and obesity did not improve their decision-making over time, and there was a direct link between their IGT performance and the severity of binge eating, suggesting a need for further research into the underlying cognitive processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision-making impairments in women with binge eating disorder in comparison with obese and normal weight women. Danner, UN., Ouwehand, C., van Haastert, NL., et al.[2022]

A comprehensive review of 50 studies on Binge-Eating Disorder (BED) identified significant cognitive dysfunctions in decision-making processes, including deficits in Uncertainty Evaluation, Attentional Inhibition, Choice Consistency, and Cognitive Flexibility.

These findings suggest that targeting these specific cognitive processes through interventions could help address the treatment gap in BED, offering a new approach to managing the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctional decision-making in binge-eating disorder: A meta-analysis and systematic review. Colton, E., Wilson, KE., Chong, TT., et al.[2023]

A short-term Cognitive-Behavioral Treatment (CBT) for Binge Eating Disorder (BED) showed significant improvement in core symptoms during treatment, with benefits continuing or stabilizing over a four-year follow-up period for 41 patients.

Factors such as higher weight, increased eating concern, and more frequent binge episodes at the end of treatment were identified as predictors of long-term success, suggesting that personalized follow-up interventions could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term cognitive-behavioral therapy for binge eating disorder: long-term efficacy and predictors of long-term treatment success. Fischer, S., Meyer, AH., Dremmel, D., et al.[2018]

Cognitive-behavioral therapy led by a therapist (CBTth) is significantly more effective than guided self-help (CBTgsh) for treating binge-eating disorder, with a 20-fold higher likelihood of treatment completion and nearly 15-fold higher likelihood of remission based on a study of 457 participants.

Weight concern plays a crucial role in treatment outcomes, with lower weight concern associated with better remission rates in both CBT methods, but longer treatment duration positively impacts remission in CBTth while negatively affecting CBTgsh.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical moderators and predictors of cognitive-behavioral therapy by guided-self-help versus therapist-led for binge-eating disorder: Analysis of aggregated clinical trials. Grilo, CM., Thompson-Brenner, H., Shingleton, RM., et al.[2022]

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