Clinical trial NCT04242550: Binge Eating Anxiety and Mood
Official title: Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Binge Eating
Anxiety Disorders
Mood Disorders
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2020-01-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Feasibility as measured by number of treatment sessions attended
timeFrame: Over the course of 4 months of treatment
measure: Acceptability
timeFrame: At 4 months
Secondary outcomes:
measure: Binge Eating
timeFrame: Through study completion, an average of 6 months
measure: Impairment
timeFrame: Through study completion, an average of 6 months
Other outcomes:
measure: Anxiety Symptoms
timeFrame: Through study completion, an average of 6 months
measure: Depression Symptoms
timeFrame: Through study completion, an average of 6 months
Locations:
city: San Diego
country: United States
facility: Ucsd Chear
state: California
Study officials:
affiliation: UC San Diego
name: Dawn M Eichen, PhD
role: PRINCIPAL_INVESTIGATOR
References: