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Behavioral Intervention
Mindfulness Meditation-Enhanced Cognitive Behavioral Therapy for Binge Eating Disorder
N/A
Recruiting
Research Sponsored by Yeshiva University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Be older than 18 years old
Must not have
Requiring immediate treatment for medical complications
Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-week treatment period
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new therapy program for binge eating disorder that combines mindfulness and cognitive behavioral therapy over 18 weeks. The researchers are first testing the program's feasibility and acceptability in a single-arm
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves non-invasive practices such as meditation and therapy, no significant side effects are expected. Participants may experience emotional discomfort addressing their eating disorder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need urgent treatment for my health issues.
Select...
I am currently in treatment for an eating disorder or participating in a weight loss program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18-week treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-week treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility/Completion
Secondary study objectives
Change in Body Mass Index (BMI)
Changes in Depression Symptoms
Changes in Dietary Restraint
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Digital CBT-MMExperimental Treatment1 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.
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Who is running the clinical trial?
Yeshiva UniversityLead Sponsor
11 Previous Clinical Trials
2,597 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
674,946 Total Patients Enrolled