Binge Eating Disorder, Overweight and Obesity
Conditions
Keywords
binge eating disorder, obesity, cognitive behavioral therapy
Brief 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.
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALWaitlist
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
Sponsors
National Institute of Nursing Research (NINR)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women who meet the DSM-5 criteria for BED as diagnosed by the Eating Disorder Examination Interview 2. Ages 18 to 45 years of age 3. BMI \>/=25 kg/m2 4. Premenopausal 5. Able to provide informed consent 6. Right-handed 7. 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 8. 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
1. Weight \> 158.8 kg (350 lbs, due to scanner weight restrictions) 2. Supine abdominal width (with arms folded above) \> 70 cm or sagittal diameter \> 50 cm (due to scanner dimension restrictions) 3. Pregnant or nursing (or plans to become pregnant in the next 5 months) 4. Evidence of psychiatric disorder that significantly interferes with daily living 5. Active suicidal ideation 6. Type 1 diabetes or type 2 diabetes or A1C \> 6.5% 7. 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 8. Psychiatric hospitalization within the past 6 months 9. Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week) 10. Self-reported use of illicit drugs within the past 30 days 11. Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging 12. Loss of ≥ 10 lb of body weight within the past 3 months 13. History of (or plans for) bariatric surgery 14. Visual, auditory, or other impairment that would affect task performance 15. Epilepsy or other brain injury 16. Participation in individual psychotherapy for BED in the prior 3 months 17. Inability to attend treatment and lack of capacity to provide informed consent 18. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Episodes | Change from baseline to 16 weeks | Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes. |
| Reward-based Eating Drive | Change from baseline to 16 weeks | Change measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive. |
| Dietary Disinhibition | Change from baseline to 16 weeks | Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | Cognitive Behavioral Therapy |
|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 8 | 30 years STANDARD_DEVIATION 7 | 30 years STANDARD_DEVIATION 8 |
| Binge eating | 13 episodes in past 4 weeks STANDARD_DEVIATION 1 | 13 episodes in past 4 weeks STANDARD_DEVIATION 1 | 13 episodes in past 4 weeks STANDARD_DEVIATION 1 |
| Disinhibition | 13 units on a scale STANDARD_DEVIATION 1 | 13 units on a scale STANDARD_DEVIATION 2 | 14 units on a scale STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Reward-based eating | 35 units on a scale STANDARD_DEVIATION 2 | 37 units on a scale STANDARD_DEVIATION 8 | 38 units on a scale STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Change from baseline to 16 weeks
Population: Fewer participants had usable data for the fMRI analysis than the overall trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy | Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery | -0.2 percent signal change | Standard Error 0.1 |
| Waitlist Control | Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Binge-eating Script-driven Imagery | -0.3 percent signal change | Standard Error 0.2 |
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
Time frame: Change from baseline to 16 weeks
Population: Fewer participants had usable data for the fMRI analysis than the overall trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy | Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task | -0.4 percent signal change | Standard Error 0.1 |
| Waitlist Control | Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Response to Food-specific Stop-signal Task | -0.3 percent signal change | Standard Error 0.1 |
Secondary
Binge Eating Episodes
Change in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Time frame: Change from baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy | Binge Eating Episodes | -9 episodes in the past 28 days | Standard Error 2 |
| Waitlist Control | Binge Eating Episodes | -4 episodes in the past 28 days | Standard Error 2 |
Secondary
Dietary Disinhibition
Self-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
Time frame: Change from baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy | Dietary Disinhibition | -4 score on a scale | Standard Error 1 |
| Waitlist Control | Dietary Disinhibition | 0 score on a scale | Standard Error 1 |
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.
Time frame: Change from baseline to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy | Reward-based Eating Drive | -15 score on a scale | Standard Error 3 |
| Waitlist Control | Reward-based Eating Drive | 3 score on a scale | Standard Error 3 |