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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23NR017209-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy | Experimental | 16-week cognitive behavioral therapy intervention for binge eating disorder |
|
| Waitlist control | Other | 16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Change from baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating Episodes | Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes. | Change from baseline to 16 weeks |
| Reward-based Eating Drive |
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Inclusion Criteria:
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
Eligible female patients will be:
Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariana M Chao, PhD, CRNP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38953334 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy | 16-week cognitive behavioral therapy intervention for binge eating disorder Cognitive behavioral therapy: 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. |
| FG001 | Waitlist Control | 16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy | 16-week cognitive behavioral therapy intervention for binge eating disorder Cognitive behavioral therapy: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Fewer participants had usable data for the fMRI analysis than the overall trial. | Posted | Mean | Standard Error | percent signal change | Change from baseline to 16 weeks |
|
Baseline to end of intervention (16 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy | 16-week cognitive behavioral therapy intervention for binge eating disorder Cognitive behavioral therapy: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariana Chao | University of Pennsylvania | 215-746-7183 | arichao@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2020 | Oct 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001071 | Appointments and Schedules |
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| Waitlist | Behavioral | The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. |
|
Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.
| 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. | Change from baseline to 16 weeks |
| Waitlist Control |
16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Binge eating | Mean | Standard Deviation | episodes in past 4 weeks |
|
| Reward-based eating | Mean | Standard Deviation | units on a scale |
|
| Disinhibition | Mean | Standard Deviation | units on a scale |
|
| OG001 | Waitlist Control | 16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. |
|
|
| Primary | 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. | Fewer participants had usable data for the fMRI analysis than the overall trial. | Posted | Mean | Standard Error | percent signal change | Change from baseline to 16 weeks |
|
|
|
| Secondary | Binge Eating Episodes | Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes. | Posted | Mean | Standard Error | episodes in the past 28 days | Change from baseline to 16 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Change from baseline to 16 weeks |
|
|
|
| Secondary | Dietary Disinhibition | Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating. | Posted | Mean | Standard Error | score on a scale | Change from baseline to 16 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Waitlist Control | 16-weeks on waitlist then participants will be provided with 16-weeks of cognitive behavioral therapy Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |