Binge Eating Anxiety and Mood

Not Applicable

Completed

• Conditions: Binge Eating; Mood Disorders; Anxiety Disorders; Binge-Eating Disorder
• Interventions: Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT); Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT04242550
• Lead Sponsor: University of California, San Diego

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-06-23
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Executive Function- Enhanced CBT for BED (EF-BED+CBT)	Executive Function- Enhanced CBT for BED (EF-BED+CBT)	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.
Executive Function- Enhanced CBT for BED (EF-BED+CBT)	Cognitive Behavioral Therapy (CBT)	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.
Cognitive Behavioral Therapy (CBT)	Cognitive Behavioral Therapy (CBT)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Binge Eating	Through study completion, an average of 6 months	Change in binge eating episodes measured by the Eating Disorder Examination interview
Impairment	Through study completion, an average of 6 months	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.

Trial Locations

Locations (1)

Ucsd Chear; 🇺🇸 San Diego, California, United States