Cognitive Behavioural Therapy + Mindfulness for Binge Eating Disorder

Overseen By Hedy Kober, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yeshiva University

Must not be taking: Weight loss medications

Disqualifiers: Anorexia, Bulimia, Pregnancy, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for people with binge eating disorder (BED). Researchers compare a digital program that combines mindfulness and cognitive behavioral therapy (CBT) with self-monitoring to self-monitoring alone. The goal is to determine if this new method is user-friendly and effective in managing BED symptoms. Suitable participants have experienced BED for the past three months and can commit to the study's activities. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing BED symptoms.

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

The trial does not require you to stop taking medications for conditions other than binge eating disorder or weight loss. However, you cannot be on medications specifically for weight loss or have started medications that affect eating or weight in the last six months.

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

Research has shown that Cognitive Behavioral Therapy (CBT) is a safe and effective treatment for eating disorders. Studies have found that CBT reduces binge eating episodes and improves overall emotional well-being.

Mindfulness-based treatments are also safe and beneficial. They have decreased the severity of binge eating and helped individuals manage emotions more effectively.

No major safety issues have emerged for these therapies. Both CBT and mindfulness have been well-tolerated in past research, making them promising options for those considering this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CBT-based Mindful Courage treatment for binge eating disorder because it integrates mindfulness with cognitive behavioral therapy in a digital format. Unlike traditional CBT, which often involves in-person sessions, this treatment provides flexibility through self-guided modules, allowing individuals to engage at their own pace. Additionally, it emphasizes regular mindfulness practice, helping individuals develop awareness and acceptance of binge eating urges, which is not a standard focus in current treatments. This approach could offer a more accessible and comprehensive way to address the psychological aspects of binge eating disorder.

What evidence suggests that this trial's treatments could be effective for binge eating disorder?

Research has shown that combining cognitive behavioral therapy (CBT) with mindfulness can greatly reduce binge eating episodes. In one study, participants experienced fewer binge eating episodes and showed improvement in their eating disorder symptoms. This trial will test two different approaches: the digital intervention CBT-based Mindful Courage, which integrates mindfulness and CBT elements, and Coached Self-Monitoring. The digital version of this treatment, such as Mindful Courage, has proven effective for people with binge eating disorder. Another study found that individuals using an online CBT self-help tool achieved better results than those who did not use it. Overall, these findings suggest that a digital approach combining CBT and mindfulness could be a promising way to manage binge eating disorder. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with Binge Eating Disorder (BED) in the past three months, can speak English fluently, and are willing to commit to the full study protocol.

Inclusion Criteria

I can speak English fluently.

I have been diagnosed with binge eating disorder recently.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-intervention

1 visit (in-person)

Baseline

Initial baseline visit to assess participants before starting the intervention

1 week

1 visit (in-person)

Treatment

Participants undergo a 16-session digital mindfulness-based and cognitive behavioral therapy (CBT) intervention

16 weeks

Self-guided modules with phone coaching

Mid-study

Mid-study visit to assess progress and make any necessary adjustments

Midway through treatment

1 visit (in-person)

Post-intervention

Post-intervention assessment to evaluate outcomes after completing the intervention

Approximately 18 weeks after baseline

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CBT-based Mindful Courage
• Coached Self-Monitoring

Trial Overview The trial is testing a digital program combining mindfulness-based therapy and cognitive behavioral therapy (CBT) for BED, plus coached self-monitoring versus just coached self-monitoring alone. It's a pilot randomized controlled trial with 16 sessions.

How Is the Trial Designed?

Group I: CBT-based Mindful Courage + Coached Self-Monitoring Experimental Treatment 2 Interventions

CBT-based Mindful Courage is a digital intervention including mindfulness and CBT elements for individuals with binge eating disorder. It will consist of 16 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 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. Participants will also be asked to self-monitor their food intake in Recovery Record and will receive phone coaching.

Group II: Coached Self-Monitoring Active Control 1 Intervention

Participants will be asked to self-monitor their food intake in Recovery Record and will receive phone coaching

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11099688/

Effectiveness of a Web-Based Cognitive Behavioral Self-Help ... In this randomized clinical trial involving 154 patients with BED, access to a web-based cognitive behavioral self-help intervention was superior to a waiting- ...

2. 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 ...

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

A Pilot Open Trial of a Digital Mindfulness-Based ... We found medium-to-large significant reductions in eating disorder symptoms. Abstract. Anorexia nervosa (AN) is a chronic and debilitating psychiatric disorder.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40350587/

Combining Cognitive-Behaviour Therapy With Mindfulness ... Participants reported large and significant decreases in binge eating episodes (d = 0.86) and BES scores (d = 0.91) as well as medium and significant decreases ...

5. researchgate.net researchgate.net/publication/391667648_Combining_Cognitive-Behaviour_Therapy_With_Mindfulness_Training_in_a_Digital_Intervention_for_Binge_Eating_Disorder_A_Single-Session_Pilot_Trial

Combining Cognitive-Behaviour Therapy With Mindfulness ... Participants reported large and significant decreases in binge eating episodes ( d = 0.86) and BES scores ( d = 0.91) as well as medium and significant ...

6. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07212673

Combining Digital Cognitive-behavior Therapy With ... Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder ... Behavioral : CBT-based Mindful Courage ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2928448/

Cognitive Behavioral Therapy for Eating Disorders - PMC Cognitive behavioral therapy (CBT) is the leading evidence-based treatment for bulimia nervosa. A new “enhanced” version of the treatment appears to be more ...

9. jneuropsychiatry.org jneuropsychiatry.org/peer-review/mindfulness-as-therapy-for-disordered-eating-a-systematic-review-neuropsychiatry.pdf

Mindfulness as therapy for disordered eating: a systematic ... behavior therapy (DBT), mindfulness-based cognitive therapy (MBCT), mindfulness-based eating awareness training (MB-EAT), and acceptance and commitment ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022399921002373

Two decades of mindfulness-based interventions for binge ... Mindfulness-based interventions (MBIs) reduce binge eating severity. · MBIs reduce depression and increase emotional regulation.. · MBIs seem to help clinical, ...