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Binge Eating Anxiety and Mood (BEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242550
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Dawn Eichen, 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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Binge Eating Anxiety Disorders Mood Disorders Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT) Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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 : June 23, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  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 the Client Satisfaction Questionnaire and responses to Likert-type ratings developed by the study team. The Client Satisfaction Questionnaire is an 8-item questionnaire with possible scores ranging from 8-32, with higher scores indicating greater satisfaction.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242550


Contacts
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Contact: Ellen K Pasquale, BS (858)380-5579 ekpasquale@health.ucsd.edu
Contact: Dawn M Eichen, PhD (858)534-8322 deichen@health.ucsd.edu

Locations
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United States, California
Ucsd Chear Recruiting
San Diego, California, United States, 92037
Contact: Ellen Pasquale, BS    858-380-5579    ekpasquale@health.ucsd.edu   
Contact: Dawn M Eichen, PhD    858-534-8322    deichen@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Dawn M Eichen, PhD UC San Diego
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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: January 27, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Bulimia
Anxiety Disorders
Feeding and Eating Disorders
Binge-Eating Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms