Trial Outcomes & Findings for Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder (NCT NCT03604172)
NCT ID: NCT03604172
Last Updated: 2023-04-18
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Change from baseline to 16 weeks
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Neural Response to Food Stimuli: fMRI Changes Following Cognitive Behavioral Therapy for Binge Eating Disorder
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy
n=20 Participants
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.
|
Waitlist Control
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 8 • n=5 Participants
|
30 years
STANDARD_DEVIATION 8 • n=7 Participants
|
30 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Binge eating
|
13 episodes in past 4 weeks
STANDARD_DEVIATION 1 • n=5 Participants
|
13 episodes in past 4 weeks
STANDARD_DEVIATION 1 • n=7 Participants
|
13 episodes in past 4 weeks
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Reward-based eating
|
38 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
35 units on a scale
STANDARD_DEVIATION 2 • n=7 Participants
|
37 units on a scale
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Disinhibition
|
14 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
13 units on a scale
STANDARD_DEVIATION 1 • n=7 Participants
|
13 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Fewer participants had usable data for the fMRI analysis than the overall trial.
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
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=18 Participants
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.
|
Waitlist Control
n=16 Participants
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.
|
|---|---|---|
|
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
|
-0.3 percent signal change
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Fewer participants had usable data for the fMRI analysis than the overall trial.
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.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=18 Participants
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.
|
Waitlist Control
n=16 Participants
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.
|
|---|---|---|
|
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
|
-0.3 percent signal change
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksChange in number of episodes measured from the Eating Disorder Examination Questionnaire. Higher values indicate more episodes.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=20 Participants
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.
|
Waitlist Control
n=20 Participants
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.
|
|---|---|---|
|
Binge Eating Episodes
|
-9 episodes in the past 28 days
Standard Error 2
|
-4 episodes in the past 28 days
Standard Error 2
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksChange measured from the Reward-Based Eating Drive Scale. Range of 0-52 with higher scores indicting higher reward-based eating drive.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=20 Participants
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.
|
Waitlist Control
n=20 Participants
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.
|
|---|---|---|
|
Reward-based Eating Drive
|
-15 score on a scale
Standard Error 3
|
3 score on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksSelf-report measured from the Eating Inventory Questionnaire. Score range of 0-16. Higher scores indicate higher levels of disinhibited eating.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=20 Participants
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.
|
Waitlist Control
n=20 Participants
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.
|
|---|---|---|
|
Dietary Disinhibition
|
-4 score on a scale
Standard Error 1
|
0 score on a scale
Standard Error 1
|
Adverse Events
Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place