Binge-Eating Disorder, Obesity
Conditions
Brief summary
This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .
Detailed description
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).
Interventions
BEHAVIORALCognitive-Behavioral Therapy (CBT)
CBT specialist treatment
DRUGNB Medication (on-going from acute treatment)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participated in acute treatment for binge-eating disorder and obesity; * Did not have a positive response to acute treatment; * Available for the duration of the treatment and follow-up (20 months); * Read, comprehend, and write English at a sufficient level to complete study-related materials; and * Able to travel to study location (New Haven, CT) for weekly visits.
Exclusion criteria
* Currently taking anti-depressant medications; * Currently taking opioid pain medications or drugs; * Currently taking medications that influence eating/weight; * History of seizures; * Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * Past or current anorexia nervosa, bulimia nervosa; * Pregnant or breastfeeding; * Medical status judged by study physician as contraindication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | Post-treatment (4 months) | Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously. |
| Change in Body Mass Index at 4 Months Post-Treatment From Baseline | Baseline and Post-treatment (4 months) | BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | 6-Month Follow-up | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 12-Month Follow-up | BMI is calculated using measured height and weight (e.g., percent loss). |
Countries
United States
Participant flow
Pre-assignment details
This study is part of a larger RCT (NCT03045341). In this study, we randomized participants who were non-responders to acute treatment to receive either CBT or no CBT. They continued the pharmacotherapy from the earlier treatment. Because of this study design, we report results based on the primary aim of the study (CBT vs no CBT). Also because of this study design, we report adverse events that were systematically assessed as potentially related to the pharmacotherapy (not to CBT).
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy CBT is a specialist focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.
Cognitive-Behavioral Therapy (CBT): CBT specialist treatment
NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) | 18 |
| On-going Blinded Pharmacotherapy Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.
NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) | 13 |
| Total | 31 |
Baseline characteristics
| Characteristic | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | Total | On-going Blinded Pharmacotherapy |
|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 13.6 | 46.3 years STANDARD_DEVIATION 13.1 | 45.1 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 27 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 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 | 14 Participants | 25 Participants | 11 Participants |
| Sex/Gender, Customized Sex/Gender Female | 13 Participants | 24 Participants | 11 Participants |
| Sex/Gender, Customized Sex/Gender Male | 4 Participants | 6 Participants | 2 Participants |
| Sex/Gender, Customized Sex/Gender Transgender | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 3 / 15 | 5 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
Binge Eating Frequency (Continuous)
Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.
Time frame: Post-treatment (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | Binge Eating Frequency (Continuous) | 0.8 Eating events/28 days | Standard Deviation 1.6 |
| On-going Blinded Pharmacotherapy | Binge Eating Frequency (Continuous) | 12.1 Eating events/28 days | Standard Deviation 9.9 |
p-value: 0.0002Mixed Models Analysis
Primary
Change in Body Mass Index at 4 Months Post-Treatment From Baseline
BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline
Time frame: Baseline and Post-treatment (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | Change in Body Mass Index at 4 Months Post-Treatment From Baseline | -0.16 Kg/m^2 | Standard Deviation 4.27 |
| On-going Blinded Pharmacotherapy | Change in Body Mass Index at 4 Months Post-Treatment From Baseline | -1.18 Kg/m^2 | Standard Deviation 4.35 |
p-value: 0.83Mixed Models Analysis
Secondary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: 6-Month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | Binge Eating Frequency (Continuous) | 2.80 eating events/28 days | Standard Deviation 6.56 |
| On-going Blinded Pharmacotherapy | Binge Eating Frequency (Continuous) | 3 eating events/28 days | — |
Secondary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: 12-Month Follow-up
Population: No participants in the on-going blinded pharmacotherapy group completed the 12-month follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | Binge Eating Frequency (Continuous) | 1.70 eating events/28 days | Standard Deviation 2.54 |
Other Pre-specified
Body Mass Index
BMI is calculated using measured height and weight (e.g., percent loss).
Time frame: 12-Month Follow-up
Population: There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.
Other Pre-specified
Body Mass Index
BMI is calculated using measured height and weight (e.g., percent loss).
Time frame: 6-Month Follow-up
Population: There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.