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Binge Eating Anxiety and Mood (BEAM)

Primary Purpose

Binge-Eating Disorder, Binge Eating, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Executive Function- Enhanced CBT for BED (EF-BED+CBT)
Cognitive Behavioral Therapy (CBT)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ucsd Chear

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Executive Function- Enhanced CBT for BED (EF-BED+CBT)

Cognitive Behavioral Therapy (CBT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility as measured by number of treatment sessions attended
Attendance at Treatment Sessions
Acceptability
Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.

Secondary Outcome Measures

Binge Eating
Change in binge eating episodes measured by the Eating Disorder Examination interview
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.

Full Information

First Posted
January 23, 2020
Last Updated
June 2, 2022
Sponsor
University of California, San Diego
Collaborators
Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04242550
Brief Title
Binge Eating Anxiety and Mood
Acronym
BEAM
Official Title
Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Binge Eating, Anxiety Disorders, Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Executive Function- Enhanced CBT for BED (EF-BED+CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Executive Function- Enhanced CBT for BED (EF-BED+CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as measured by number of treatment sessions attended
Description
Attendance at Treatment Sessions
Time Frame
Over the course of 4 months of treatment
Title
Acceptability
Description
Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.
Time Frame
At 4 months
Secondary Outcome Measure Information:
Title
Binge Eating
Description
Change in binge eating episodes measured by the Eating Disorder Examination interview
Time Frame
Through study completion, an average of 6 months
Title
Impairment
Description
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.
Time Frame
Through study completion, an average of 6 months
Other Pre-specified Outcome Measures:
Title
Anxiety Symptoms
Description
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.
Time Frame
Through study completion, an average of 6 months
Title
Depression Symptoms
Description
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.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M Eichen, PhD
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ucsd Chear
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

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Binge Eating Anxiety and Mood

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