Anxiety Disorders, Binge Eating, Binge-Eating Disorder, Mood Disorders
Conditions
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).
Interventions
BEHAVIORALExecutive 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.
BEHAVIORALCognitive 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.
Sponsors
Brain & Behavior Research Foundation
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by number of treatment sessions attended | Over the course of 4 months of treatment | Attendance at Treatment Sessions |
| Acceptability | At 4 months | Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating | Through study completion, an average of 6 months | Change in binge eating episodes measured by the Eating Disorder Examination interview |
| Impairment | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms | 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. |
| Depression Symptoms | 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. |
Countries
United States
Outcome results
None listed