Binge Eating Anxiety and Mood

Study Overview
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Brief Summary
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Binge Eating Disorder (BED) is the most common eating disorder, and currently, the best behavioral treatments only work for 40-60% of adults. BED often co-occurs with mood and anxiety disorders, and both are associated with neurocognitive deficits related to executive function (EF). These EF deficits contribute to worsening BED symptoms and make it difficult for these adults to adhere to treatment recommendations. The proposed study aims to develop an EF training enhanced behavioral treatment for BED and compare its effectiveness to the standard cognitive behavioral therapy for patients with BED and a co-occurring mood or anxiety disorder.

Detailed Description
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A randomized controlled trial (RCT) will evaluate an EF training enhanced cognitive behavioral therapy (CBT) for BED (EF-BED+CBT) compared to standard CBT in patients with BED and a comorbid mood/anxiety disorder to assess the feasibility, acceptability, and preliminary efficacy of EF-BED+CBT in reducing binge eating, impairment, and comorbid depression/anxiety symptoms. Adult participants with BED and comorbid mood/anxiety disorder will be randomized to a four month remote treatment of either EF-BED+CBT or CBT alone. Participants will be assessed at baseline, following treatment (month 4) and 2-month follow-up (month 6).

Official Title
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Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders

Conditions
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Binge-Eating Disorder, Binge Eating, Anxiety Disorders, Mood Disorders

Intervention / Treatment
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* Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Ability to read English at a 6th grade level Clinical or subclinical BED and at least one comorbid mood or anxiety disorder Exclusion Criteria: Known cognitive disability (e.g., brain injury with loss of consciousness >30 min, intellectual disability) Psychosis Psychiatric condition that could interfere with program participation (e.g., substance abuse, suicide attempt within previous 6 months, active purging, active suicidality) Currently pregnant, lactating or plan to be in the timespan of program follow-up Change in psychotropic medication or other medication that could have impact on weight, binge eating or anxiety/mood symptoms during the previous 3 months Participating in an organized program for overeating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Executive Function- Enhanced CBT for BED (EF-BED+CBT)<br>EF-BED+CBT will combine CBT with executive function training, enhancing CBT with a focus on teaching compensatory strategies, habit learning, and plan for generalization to real-world behaviors. | Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT)<br>* EF-BED+CBT will combine CBT (see description below) with executive function training. EF-BED will focus on teaching compensatory strategies to enhance adherence to the strategies recommended in CBT.<br>Behavioral: Cognitive Behavioral Therapy (CBT)<br>* CBT will be based on the Overcoming Binge Eating book. All participants will be provided a copy of the book. CBT addresses disturbed eating patterns and problematic thoughts/beliefs related to eating, shape and weight that contribute to binge eating. CBT is the current gold standard treatment for BED.<br>|
| Active Comparator: Cognitive Behavioral Therapy (CBT)<br>CBT will be based on the Overcoming Binge Eating book. CBT addresses disturbed eating patterns and problematic thoughts/beliefs related to eating, shape and weight that contribute to binge eating. CBT is the current gold standard treatment for BED. | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* CBT will be based on the Overcoming Binge Eating book. All participants will be provided a copy of the book. CBT addresses disturbed eating patterns and problematic thoughts/beliefs related to eating, shape and weight that contribute to binge eating. CBT is the current gold standard treatment for BED.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by number of treatment sessions attended | Attendance at Treatment Sessions | Over the course of 4 months of treatment | 
| Acceptability | Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team. | At 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating | Change in binge eating episodes measured by the Eating Disorder Examination interview | Through study completion, an average of 6 months | 
| Impairment | Change in impairment measured by the Clinical Impairment Assessment (CIA). The CIA is a 16-item questionnaire with possible scores ranging from 0-48 with a higher score indicating a greater level of impairment. | Through study completion, an average of 6 months |