BEAM: Binge Eating Anxiety and Mood

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT04242550
Collaborator
Brain & Behavior Research Foundation (Other)
39
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2
17.1
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT)
  • Behavioral: Cognitive Behavioral Therapy (CBT)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders
Actual Study Start Date :
Jun 23, 2020
Actual Primary Completion Date :
Nov 24, 2021
Actual Study Completion Date :
Nov 24, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility as measured by number of treatment sessions attended [Over the course of 4 months of treatment]

    Attendance at Treatment Sessions

  2. Acceptability [At 4 months]

    Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.

Secondary Outcome Measures

  1. Binge Eating [Through study completion, an average of 6 months]

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

  2. 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.

Other Outcome Measures

  1. Anxiety Symptoms [Through study completion, an average of 6 months]

    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.

  2. Depression Symptoms [Through study completion, an average of 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ucsd Chear San Diego California United States 92037

Sponsors and Collaborators

  • University of California, San Diego
  • Brain & Behavior Research Foundation

Investigators

  • Principal Investigator: Dawn M Eichen, PhD, UC San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dawn Eichen, Assistant Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04242550
Other Study ID Numbers:
  • NARSAD YI 27943
First Posted:
Jan 27, 2020
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022