Binge Eating Anxiety and Mood

NCT ID: NCT04242550

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2021-11-24

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).

Conditions

Binge-Eating Disorder; Binge Eating; Anxiety Disorders; Mood Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Dawn Eichen

Assistant Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn M Eichen, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

Ucsd Chear

San Diego, California, United States

Countries

United States

References

Eichen DM, Strong DR, Twamley EW, Boutelle KN. Adding executive function training to cognitive behavioral therapy for binge eating disorder: A pilot randomized controlled trial. Eat Behav. 2023 Dec;51:101806. doi: 10.1016/j.eatbeh.2023.101806. Epub 2023 Aug 29.

Reference Type: DERIVED

PMID: 37660487 (View on PubMed)

Other Identifiers

NARSAD YI 27943

Identifier Type: -

Identifier Source: org_study_id