Binge Eating Anxiety and Mood (BEAM)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Ucsd Chear

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT); 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.; Behavioral: Cognitive Behavioral Therapy (CBT); 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.
ACTIVE_COMPARATOR: 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.	Behavioral: Cognitive Behavioral Therapy (CBT); 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms	Change in anxiety symptoms measured by the General Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item questionnaire with scores ranging from 0-21 and a higher score indicating greater anxiety severity.	Through study completion, an average of 6 months
Depression Symptoms	Change in depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire with scores ranging from 0-27 and a higher score indicating greater depression severity.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Brain & Behavior Research Foundation
• Investigators: Principal Investigator: Dawn M Eichen, PhD, UC San Diego

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ACTUAL): November 24, 2021
• Study Completion (ACTUAL): November 24, 2021

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Anxiety Disorders; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Mood Disorders
• Other Study ID Numbers: NARSAD YI 27943

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No