Binge Eating Anxiety and Mood

Anxiety Disorders Clinical Trial

— BEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242550
• Other study ID #: NARSAD YI 27943
• Status: Completed
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: November 24, 2021

Study information

• Verified date: June 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders
• Mood Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ucsd Chear	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Feasibility as measured by number of treatment sessions attended	Attendance at Treatment Sessions	Over the course of 4 months of treatment
Primary	Acceptability	Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.	At 4 months
Secondary	Binge Eating	Change in binge eating episodes measured by the Eating Disorder Examination interview	Through study completion, an average of 6 months
Secondary	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