Binge Eating DisorderNCT03604172
Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
A study testing Cognitive behavioral therapy and Waitlist in people with Binge Eating Disorder and Overweight and Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the impact of CBT on neural responses to binge eating stimuli. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder, Overweight and Obesity
- What is being tested?
- Cognitive behavioral therapy and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
- Ages 18 to 45 years of age
- BMI >/=25 kg/m2
- Premenopausal
- Able to provide informed consent
- Right-handed
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- Eligible female patients will be:
- Non-pregnant, evidenced by a negative urine dipstick pregnancy test
- Non-lactating
- Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study
- Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Who cannot join
- Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
- Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
- Pregnant or nursing (or plans to become pregnant in the next 5 months)
- Evidence of psychiatric disorder that significantly interferes with daily living
- Active suicidal ideation
- Type 1 diabetes or type 2 diabetes or A1C > 6.5%
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- Use of weight loss medications or other agents known to affect body weight (e.g., oral glucocorticoids, second-generation antipsychotic medications) in the past 3 months
- Psychiatric hospitalization within the past 6 months
- Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
- Self-reported use of illicit drugs within the past 30 days
- Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
- Loss of ≥ 10 lb of body weight within the past 3 months
- History of (or plans for) bariatric surgery
- Visual, auditory, or other impairment that would affect task performance
- Epilepsy or other brain injury
- Participation in individual psychotherapy for BED in the prior 3 months
- Inability to attend treatment and lack of capacity to provide informed consent
- Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the impact of CBT on neural responses to binge eating stimuli.
Read the detailed description
Females with a BMI>/=25 kg/m2 and BED will be randomized to either a 16-week, one-on-one CBT intervention (n=20) or a waitlist control (WL; n=20). Both groups will have blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. During the scans, participants will complete the following tasks: 1) food-specific stop signal task (SST), and 2) script-driven imagery of binge foods.
- Conditions
- Binge Eating Disorder, Overweight and Obesity
- Being tested
- Cognitive behavioral therapy, Waitlist
- Keywords
- binge eating disorder, obesity, cognitive behavioral therapy
- Medical subject headings
- Binge-Eating Disorder, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
The cognitive behavioral therapy intervention will consist of weekly, 50-minute individual meetings for 16 weeks with a clinician trained in cognitive behavioral therapy for binge eating disorder.
WaitlistBehavioural
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | 16-week cognitive behavioral therapy intervention for binge eating disorder Receives: Behavioral: Cognitive behavioral therapy |
| Waitlist control | Other | 16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
BOLD fMRI (neural) response to high-calorie food cues during the food-specific stop-signal task in reward regions of interest. Reward-regions included BOLD response of the combination of prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum
Measured: Change from baseline to 16 weeks
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery
BOLD fMRI response to descriptions of binge eating episodes during script-driven imagery (contrast in reward-regions of interest between food vs neutral stimuli). Reward-regions included combination of BOLD response in the prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum.
Measured: Change from baseline to 16 weeks
Secondary outcomes (3)
Binge Eating Episodes
Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Measured: Change from baseline to 16 weeks
Reward-based Eating Drive
Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.
Measured: Change from baseline to 16 weeks
Dietary Disinhibition
Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
Measured: Change from baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start8 Aug 2018
- Primary completion23 Jun 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ariana M Chao, PhD, CRNP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604172
- Sponsor's protocol ID
- 829018
- Other IDs
- 5K23NR017209-03
- Status last verified
- Mar 2023
- First submitted
- 19 Jun 2018
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chao AM, Agarwal K, Zhou Y, Grilo CM, Gur RC, Joseph P, Shinohara RT, Richmond TS, Wadden TA. Neural Responses to Auditory Food Stimuli Following Cognitive Behavioral Therapy for Binge-Eating Disorder. Int J Eat Disord. 2024 Sep;57(9):1911-1923. doi: 10.1002/eat.24244. Epub 2024 Jul 2.
PubMed 38953334
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT03604172
- Acronym / sponsor ID
- 829018
- Conditions
- Binge Eating Disorder, Overweight and Obesity
- Keywords
- binge eating disorder, obesity, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to conduct a randomized controlled trial (RCT) assessing the impact of CBT on neural responses to binge eating stimuli.
Detailed description
Females with a BMI>/=25 kg/m2 and BED will be randomized to either a 16-week, one-on-one CBT intervention (n=20) or a waitlist control (WL; n=20). Both groups will have blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. During the scans, participants will complete the following tasks: 1) food-specific stop signal task (SST), and 2) script-driven imagery of binge foods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapy16-week cognitive behavioral therapy intervention for binge eating disorder |
| Waitlist control | Other | Behavioral: Waitlist16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview
- Ages 18 to 45 years of age
- BMI >/=25 kg/m2
- Premenopausal
- Able to provide informed consent
Key exclusion criteria (18 listed)
- Weight > 158.8 kg (350 lbs, due to scanner weight restrictions)
- Supine abdominal width (with arms folded above) > 70 cm or sagittal diameter > 50 cm (due to scanner dimension restrictions)
- Pregnant or nursing (or plans to become pregnant in the next 5 months)
- Evidence of psychiatric disorder that significantly interferes with daily living
- Active suicidal ideation
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 |
|---|---|---|
| Cognitive behavioral therapyThe cognitive behavioral therapy intervention will consist of weekly, 50-minute individual meetings for 16 weeks with a clinician trained in cognitive behavioral therapy for binge eating disorder. | Behavioural | Cognitive behavioral therapy |
| WaitlistThe waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. | Behavioural | Waitlist control |
Primary outcome
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task
Time frame: Change from baseline to 16 weeks
BOLD fMRI (neural) response to high-calorie food cues during the food-specific stop-signal task in reward regions of interest. Reward-regions included BOLD response of the combination of prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery
Time frame: Change from baseline to 16 weeks
BOLD fMRI response to descriptions of binge eating episodes during script-driven imagery (contrast in reward-regions of interest between food vs neutral stimuli). Reward-regions included combination of BOLD response in the prefrontal cortex, orbitofrontal cortex, insula, ventral tegmental area, and ventral striatum.
3 secondary outcomes
Binge Eating Episodes
Time frame: Change from baseline to 16 weeks
Reward-based Eating Drive
Time frame: Change from baseline to 16 weeks
Dietary Disinhibition
Time frame: Change from baseline to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38953334Chao AM, Agarwal K, Zhou Y, Grilo CM, Gur RC, Joseph P, Shinohara RT, Richmond TS, Wadden TA. Neural Responses to Auditory Food Stimuli Following Cognitive Behavioral Therapy for Binge-Eating Disorder. Int J Eat Disord. 2024 Sep;57(9):1911-1923. doi: 10.1002/eat.24244. Epub 2024 Jul 2.
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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.
Ariana M Chao, PhD, CRNP principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy and Waitlist in people with Binge Eating Disorder and Overweight and Obesity, run by University of Pennsylvania 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 11 inclusion and 18 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 18 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task (time frame: Change from baseline to 16 weeks). 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 NCT03604172, 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 18 Apr 2023.