Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy for Binge Eating Disorder

Recruiting at 1 trial location

Overseen By Margaret Sala, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yeshiva University

Disqualifiers: Anorexia, Bulimia, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 18 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 18-week digital therapy program for individuals with binge eating disorder. The goal is to determine if combining mindfulness meditation with cognitive behavioral therapy (a type of talk therapy focused on changing thought patterns) can help individuals better manage their eating habits. Participants will engage in self-guided activities, including mindful eating and self-awareness exercises. The trial seeks English-speaking adults with binge eating disorder who are not currently receiving treatment for this condition. As an unphased trial, this study offers a unique opportunity to explore innovative therapy methods that could enhance well-being.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are already receiving treatment for an eating disorder or participating in a weight loss program, you cannot join the trial.

What prior data suggests that this intervention is safe for individuals with binge eating disorder?

Research shows that Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (Digital CBT-MM) is generally easy for people to handle. This treatment combines mindfulness exercises with cognitive behavioral therapy (CBT) techniques to assist those with binge eating disorder. Previous studies on similar CBT-based therapies have shown they cause few side effects, and participants often find them manageable and helpful.

Mindfulness exercises, integral to this therapy, increase awareness and acceptance of thoughts and feelings. Research has shown this approach is safe for most people. Cognitive behavioral therapy, a key component of this treatment, has been safely used for many years to address various mental health issues.

Overall, Digital CBT-MM aims to improve self-awareness and self-kindness, helping people manage binge eating in a supportive and safe way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (Digital CBT-MM) is unique because it combines mindfulness with cognitive behavioral techniques specifically for binge eating disorder. Unlike traditional therapy options, which might include face-to-face CBT or medication, Digital CBT-MM is a self-guided digital program that allows users to engage with the therapy at their own pace over an 18-week period. This approach not only addresses the psychological aspects of binge eating, such as self-monitoring and behavior analysis, but it also emphasizes mindfulness practices, self-compassion, and values-based decision making. Researchers are excited about this treatment because it offers a comprehensive, accessible, and flexible option for individuals seeking help, potentially reaching a wider audience who may prefer or require digital intervention.

What evidence suggests that Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy might be an effective treatment for binge eating disorder?

This trial will evaluate Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for individuals with binge eating disorder. Studies have shown that mindfulness-based cognitive therapy can improve eating habits in those with binge eating disorder. Mindfulness practices in therapy encourage awareness and acceptance of eating urges, potentially reducing binge episodes. Research indicates that incorporating mindfulness into cognitive behavioral therapy reduces the focus on weight and body shape, common concerns for those with binge eating disorder. This combination has shown promise in enhancing self-monitoring and goal-setting, crucial for managing the disorder. Overall, the treatment aims to foster a healthier relationship with food through mindful eating and self-compassion. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Binge Eating Disorder or Bulimia. It's an early-phase study to see if people like and can stick to a digital program combining mindfulness meditation and cognitive behavioral therapy over 18 weeks.

Inclusion Criteria

Meeting DSM-5 criteria for Binge Eating Disorder (BED)

English-speaking

Exclusion Criteria

Current anorexia or bulimia nervosa or purging behaviors within the past year

BMI < 18.5

Currently pregnant or breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Initial baseline visit to assess starting conditions

1 day

1 visit (in-person)

Treatment

18-week digital mindfulness-based and cognitive behavioral therapy intervention

18 weeks

Web-based, self-guided modules

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy

Trial Overview The intervention being studied is a digital program that combines mindfulness meditation with cognitive behavioral therapy, specifically designed for those struggling with binge eating disorders.

How Is the Trial Designed?

Group I: Digital CBT-MM Experimental Treatment 1 Intervention

Digital CBT-MM is a digital intervention including mindfulness and cognitive behavioral elements for individuals with binge eating disorder. Mindful Courage will consist of 18-weeks of self-guided modules. Elements included in the intervention include psychoeducation, self-monitoring, regular eating, goal-setting, weekly weighing, eating a sufficient amount of food at each meal, eating a range of foods (including foods that patients may fear), reduction of overvaluation of weight and shape, addressing shape/body checking or avoidance, behavior chain analysis, problem solving, awareness and acceptance of binge eating urges, thoughts and emotions, values awareness, values clarification, values-based decision making, self-compassion, exploring needs underlying binge eating urges, mindful eating, hunger and fullness awareness, self-compassion, and self-care. Weekly mindfulness practice (at least 3x per week) is heavily emphasized.

Who Is Running the Clinical Trial?

Yeshiva University

Lead Sponsor

Trials

13

Recruited

2,600+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Mindfulness meditation has been found to effectively reduce binge eating and emotional eating behaviors in individuals who struggle with these issues, based on a systematic review of 14 studies.

The impact of mindfulness meditation on weight change is less clear, indicating that while it may help with eating behaviors, further research is needed to understand its effects on weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation as an intervention for binge eating, emotional eating, and weight loss: a systematic review. Katterman, SN., Kleinman, BM., Hood, MM., et al.[2022]

The study involving 66 participants with binge-eating disorder or bulimia nervosa found that the Noom Monitor app combined with guided self-help treatments (CBT-GSH) significantly reduced objective bulimic episodes compared to traditional CBT-GSH alone.

Participants using the Noom app showed better adherence to meal and snack guidelines, which helped mediate the treatment's effectiveness, although both treatments had similar remission rates at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Hildebrandt, T., Michaelides, A., Mackinnon, D., et al.[2023]

In a study of 304 patients with binge eating disorder (BED), certain baseline factors like higher drive for thinness and better interoceptive awareness were found to predict better responses to cognitive behavior therapy both immediately and 6 months after treatment.

Additionally, lower levels of binge eating pathology and body dissatisfaction in women were associated with improved treatment outcomes, suggesting that addressing these factors could enhance therapy effectiveness for BED patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of outcome for cognitive behaviour therapy in binge eating disorder. Lammers, MW., Vroling, MS., Ouwens, MA., et al.[2022]

Mindfulness-based eating awareness training (MB-EAT) is an effective group intervention for treating binge eating disorder (BED), focusing on mindfulness practices to help individuals manage emotional and behavioral responses related to food.

Current research indicates that MB-EAT can significantly reduce binge eating episodes, enhance self-control over eating, and alleviate depressive symptoms, addressing the core issues associated with BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. Kristeller, JL., Wolever, RQ.[2022]

In a pilot study involving 38 individuals with both Binge Eating Disorder (BED) and Substance Use Disorders (SUD), a 16-week group therapy using Mindfulness-Action Based Cognitive Behavioral Therapy (MACBT) led to significant improvements in binge eating episodes and addiction severity.

The results suggest that MACBT is a promising treatment option for individuals struggling with both BED and SUD, as it also positively impacted disordered eating attitudes and depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Action Based Cognitive Behavioral Therapy for concurrent Binge Eating Disorder and Substance Use Disorders. Courbasson, CM., Nishikawa, Y., Shapira, LB.[2018]

Mindfulness-based interventions (MBIs) significantly reduced binge eating severity in a meta-analysis of 11 randomized controlled trials involving 618 participants, showing an effect size of -0.39 at the end of treatment.

While MBIs were effective in reducing binge eating and also improved depression and emotion regulation, these benefits were not maintained at follow-up, indicating a need for ongoing support after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two decades of mindfulness-based interventions for binge eating: A systematic review and meta-analysis. Grohmann, D., Laws, KR.[2021]

Guided self-help cognitive behavioral therapy-enhanced (CBT-E) significantly reduced binge eating episodes from an average of 19 to 3 binges over 12 weeks, with 40% of participants achieving full recovery, indicating its efficacy as a treatment for binge eating disorder.

The study involved 180 patients in a randomized controlled trial, and while the guided self-help CBT-E group showed superior results initially, both groups had similar outcomes at follow-up after receiving treatment, highlighting the importance of access to timely care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy-Enhanced for Binge Eating Disorder: Randomized Controlled Trial. Melisse, B., Berg, EVD., Jonge, M., et al.[2023]

A 6-week meditation-based group intervention significantly reduced binge eating frequency from 4.02 to 1.57 times per week among 18 obese women, indicating its efficacy in treating Binge Eating Disorder (BED).

Participants also showed significant improvements in depression and anxiety scores, along with an increased sense of control, suggesting that mindfulness meditation can be a valuable tool in managing BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. Kristeller, JL., Hallett, CB.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06604299?cond=%22Binge-Eating%20Disorder%22&aggFilters=status:not%20rec&rank=2

NCT06604299 | Digital Mindfulness Meditation-enhanced ... Digital CBT-MM is a digital intervention including mindfulness and cognitive behavioral elements for individuals with binge eating disorder. Mindful Courage ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06604299/digital-mindfulness-meditation-enhanced-cognitive-behavioral-therapy-cbt-mm-for-binge-eating-disorder

Digital Mindfulness Meditation-enhanced Cognitive ... The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for ...

3. withpower.com withpower.com/trial/mindfulness-meditation-enhanced-cognitive-behavioral-therapy-for-binge-eating-disorder-f7571

Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy ... Yes, Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy is a promising treatment for Binge Eating Disorder. Research shows that mindfulness- ...

4. trial.medpath.com trial.medpath.com/clinical-trial/11f5c9a305f2b142/nct07212673-digital-cognitive-behavior-therapy-mindfulness-binge-eating-disorder

Combining Digital Cognitive-behavior Therapy With ... The investigators will evaluate the acceptability and feasibility of a 16-session digital mindfulness-based and cognitive behavioral therapy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8668447/

Mindfulness-based cognitive therapy added to usual care ... Mindfulness-based cognitive therapy added to usual care improves eating behaviors in patients with bulimia nervosa and binge eating disorder by decreasing the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07212673

Combining Digital Cognitive-behavior Therapy With ... CBT-based Mindful Courage is a digital intervention including mindfulness and CBT elements for individuals with binge eating disorder. It will ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789423000114

A Pilot Open Trial of a Digital Mindfulness-Based ... M.E. Atwood et al. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. International Journal of Eating Disorders. (2020).