Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy for Binge Eating Disorder

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

Trial Summary

What is the purpose of this trial?

The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

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 data supports the idea that Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy for Binge Eating Disorder is an effective treatment?

The available research shows that mindfulness-based interventions, which include Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy, have been effective in reducing the severity of binge eating. One study found that a meditation-based intervention decreased the frequency of binge eating episodes from 4.02 times per week to 1.57 times per week. This suggests that incorporating mindfulness meditation into therapy can significantly help individuals with binge eating disorder. Additionally, while other treatments like smartphone-assisted cognitive-behavioral therapy also show promise, the mindfulness approach specifically targets reducing binge eating frequency, making it a valuable option for those seeking treatment. ^{1 2 3 4 5}

What safety data exists for Mindfulness Meditation-Enhanced CBT for Binge Eating Disorder?

The provided research does not directly address safety data for Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy (CBT) for Binge Eating Disorder. However, it includes studies on related interventions like mindfulness-based interventions and meditation-based interventions for binge eating, which suggest these approaches are generally effective in reducing binge eating severity. No specific safety concerns are mentioned, indicating that these interventions may be considered safe, but further research specifically addressing safety is warranted. ^{1 2 3 5 6}

Is Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy a promising treatment for Binge Eating Disorder?

Yes, Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy is a promising treatment for Binge Eating Disorder. Research shows that mindfulness-based treatments can reduce binge eating episodes, improve self-control with eating, and decrease emotional eating. These therapies help people become more aware of their eating habits and emotions, leading to better management of binge eating. ^{1 3 6 7 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. [2023]

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

An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of outcome for cognitive behaviour therapy in binge eating disorder. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy-Enhanced for Binge Eating Disorder: Randomized Controlled Trial. [2023]

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

Mindfulness meditation as an intervention for binge eating, emotional eating, and weight loss: a systematic review. [2022]

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

Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. [2022]

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

Mindfulness-Action Based Cognitive Behavioral Therapy for concurrent Binge Eating Disorder and Substance Use Disorders. [2018]