Binge-Eating DisorderBEAMNCT04242550
Binge Eating Anxiety and Mood
A study testing Executive Function- Enhanced CBT for BED (EF-BED+CBT) and Cognitive Behavioral Therapy (CBT) in people with Binge-Eating Disorder and Binge Eating, run by University of California, San Diego at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge-Eating Disorder, Binge Eating, Anxiety Disorders
- What is being tested?
- Executive Function- Enhanced CBT for BED (EF-BED+CBT) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders
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.
Read the 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
- Being tested
- Executive Function- Enhanced CBT for BED (EF-BED+CBT), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Function- Enhanced CBT for BED (EF-BED+CBT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Executive Function- Enhanced CBT for BED (EF-BED+CBT) | Experimental | 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. Receives: Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT); Behavioral: Cognitive Behavioral Therapy (CBT) |
| Cognitive Behavioral Therapy (CBT) | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by number of treatment sessions attended
Attendance at Treatment Sessions
Measured: Over the course of 4 months of treatment
Acceptability
Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.
Measured: At 4 months
Secondary outcomes (2)
Binge Eating
Change in binge eating episodes measured by the Eating Disorder Examination interview
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start23 Jun 2020
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Dawn Eichen, University of California, San Diego
- Investigators
- Dawn M Eichen, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242550
- Sponsor's protocol ID
- NARSAD YI 27943
- Acronym
- BEAM
- Status last verified
- Jun 2022
- First submitted
- 23 Jan 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37660487
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders
- ClinicalTrials.gov ID
- NCT04242550
- Acronym / sponsor ID
- BEAM / NARSAD YI 27943
- Conditions
- Binge-Eating Disorder, Binge Eating, Anxiety Disorders, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Function- Enhanced CBT for BED (EF-BED+CBT) | Experimental | Behavioral: Executive Function- Enhanced CBT for BED (EF-BED+CBT), Behavioral: Cognitive Behavioral Therapy (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. |
| Cognitive Behavioral Therapy (CBT) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Executive Function- Enhanced CBT for BED (EF-BED+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. | Behavioural | Cognitive Behavioral Therapy (CBT), Executive Function- Enhanced CBT for BED (EF-BED+CBT) |
Primary outcome
Feasibility as measured by number of treatment sessions attended
Time frame: Over the course of 4 months of treatment
Attendance at Treatment Sessions
Acceptability
Time frame: At 4 months
Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.
2 secondary outcomes
Binge Eating
Time frame: Through study completion, an average of 6 months
Impairment
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 37660487Eichen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M Eichen, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function- Enhanced CBT for BED (EF-BED+CBT) and Cognitive Behavioral Therapy (CBT) in people with Binge-Eating Disorder and Binge Eating, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of treatment sessions attended (time frame: Over the course of 4 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.