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Completed

NCT Number: NCT04242550

Binge Eating Anxiety and Mood

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.

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Key information

Conditions

Binge-Eating Disorder Anxiety Disorders Binge Eating Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Mood Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ucsd Chear

San Diego, California, 92037, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Cognitive Behavioral Therapy (CBT)

Behavioral

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 outcomes

  1. Feasibility as measured by number of treatment sessions attended

    Time frame: Over the course of 4 months of treatment

    Attendance at Treatment Sessions

  2. Acceptability

    Time frame: At 4 months

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

Secondary outcomes

  1. Binge Eating

    Time frame: Through study completion, an average of 6 months

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

  2. Impairment

    Time frame: 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 outcomes

  1. Anxiety Symptoms

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Brain & Behavior Research Foundation

Registry information

Official study title

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

Acronym: BEAM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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