Binge Eating, Binge-Eating Disorder, Bulimia; Atypical, Bulimia Nervosa
Conditions
Keywords
Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy
Brief summary
In the current study, the investigators will revise our existing 10-session group RRT treatment manual to specifically address the challenges in building social support and enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim 1). In months 2-18, the investigators will conduct a small pilot RCT that will randomize individuals to receive either 10-sessions of RRT (n=30) or supportive therapy (n=30), both delivered as group-treatments via videoconferencing software. The specific aims of the current study are to confirm the feasibility and acceptability of RRT for EDs (Primary Aim 1), evaluate the ability of RRT to engage critical targets including reward to day-to-day life activities, reward to palatable foods, social isolation, and loneliness (Primary Aim 2), and provide preliminary estimates of efficacy in reducing ED symptoms at both post-treatment and a 3-month follow-up (Primary Aim 3). the investigators will also evaluate the impact of RRT on secondary outcome variables including depression, substance use, and quality of life (Secondary Aim 1).
Interventions
BEHAVIORALReward Re-Training
A brief, 10-session group-based behavioral treatment that is designed to indirectly change binge eating by directly focusing on building a more rewarding life. RRT hypothesizes that reductions in binge eating will occur as life becomes more rewarding because individuals will no longer need to rely on binge eating as a primary source of momentary reward. RRT notes that in order to live a satisfying life, individuals need to experience an adequate amount of reward in two overlapping yet distinguishable domains: momentary reward (i.e., the active experience of pleasure in the moment) and sustained reward (i.e., a deeper and more long-lasting sense of fulfillment and meaning that arises from building a personally valued life). A key aspect of RRT is an emphasize on building lasting and meaningful social relationships given the clear evidence that social connectedness can enhance both momentary reward and sustained reward.
BEHAVIORALSupportive Therapy
A brief, 10-session group-based treatment that is designed to instill hope and optimism and to increase social connection and support through a non-directive group leader that allows the patients to determine the focus of each session. The group leader will act as an empathetic provider by using reflective listening, eliciting and validating affect, and offering empathic comments.
Sponsors
National Institute of Mental Health (NIMH)
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Have experienced 12 or more loss of control episodes within the previous 3 months 2. Have a BMI above 18.5 3. Are located in the US and willing/able to participate in remote treatment and assessments 4. Are able to give consent
Exclusion criteria
1. Are unable to fluently speak, write and read English 2. Have a BMI below 18.5 3. Are receiving treatment for an eating disorder 4. Require immediate treatment for medical complications as a result of eating disorder symptoms 5. Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency Assessed by the Eating Disorder Examination | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination |
| Global Eating Pathology | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology. |
| Remission Status | Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment). | A participant is considered to be in remission if they had no loss of control eating episodes or compensatory behaviors in the past 28 days, as well as an EDE global score less than 1.74 (which is within one standard deviation of community norms). |
| Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use Assessed by the NIDA-Modified ASSIST | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | Frequency of substance use (number of days/month) assessed by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). |
| Quality of Life Assessed by the Quality of Life Inventory (QOLI) | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | Assesses the importance of 16 given life domains have on influencing happiness and current satisfaction level regarding these 16 life domains. Scores range from 1-77 with higher scores indicating better quality of life. |
| Depressive Symptoms as Assessed by the Beck Depression Inventory-II | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. | Assesses the type (description of certain feelings or attitudes) and intensity (how often or how much the feelings and attitudes are present) of various depressive symptoms using a total score. The scale ranges from 0-63 with higher scores indicating worse depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reward Re-Training 10 weekly sessions of Reward Re-Training Group Therapy.
Reward Re-Training: A brief, 10-session group-based behavioral treatment that is designed to indirectly change binge eating by directly focusing on building a more rewarding life. RRT hypothesizes that reductions in binge eating will occur as life becomes more rewarding because individuals will no longer need to rely on binge eating as a primary source of momentary reward. RRT notes that in order to live a satisfying life, individuals need to experience an adequate amount of reward in two overlapping yet distinguishable domains: momentary reward (i.e., the active experience of pleasure in the moment) and sustained reward (i.e., a deeper and more long-lasting sense of fulfillment and meaning that arises from building a personally valued life). A key aspect of RRT is an emphasize on building lasting and meaningful social relationships given the clear evidence that social connectedness can enhance both momentary reward and sustained reward. | 29 |
| Supportive Therapy 10 weekly sessions of Supportive Group Therapy.
Supportive Therapy: A brief, 10-session group-based treatment that is designed to instill hope and optimism and to increase social connection and support through a non-directive group leader that allows the patients to determine the focus of each session. The group leader will act as an empathetic provider by using reflective listening, eliciting and validating affect, and offering empathic comments. | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Reward Re-Training | Supportive Therapy | Total |
|---|---|---|---|
| Age, Continuous | 40.79 years STANDARD_DEVIATION 13.3 | 40.37 years STANDARD_DEVIATION 12.36 | 40.58 years STANDARD_DEVIATION 12.72 |
| Baseline EDE Global Score | 2.72 Scores on a scale STANDARD_DEVIATION 0.91 | 2.70 Scores on a scale STANDARD_DEVIATION 0.99 | 2.71 Scores on a scale STANDARD_DEVIATION 0.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) White | 13 Participants | 19 Participants | 32 Participants |
| Sex/Gender, Customized Sex at Birth Female | 24 Participants | 23 Participants | 47 Participants |
| Sex/Gender, Customized Sex at Birth Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Binge Eating Frequency Assessed by the Eating Disorder Examination
Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Pretreatment | 25.10 Binge eating episodes | Standard Deviation 22.56 |
| Reward Re-Training | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Mid-treatment | 9.19 Binge eating episodes | Standard Deviation 13.95 |
| Reward Re-Training | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Posttreatment | 8.94 Binge eating episodes | Standard Deviation 12.1 |
| Reward Re-Training | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at 3-month Follow-up | 6.38 Binge eating episodes | Standard Deviation 16.77 |
| Supportive Therapy | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at 3-month Follow-up | 4.35 Binge eating episodes | Standard Deviation 6.54 |
| Supportive Therapy | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Pretreatment | 25.27 Binge eating episodes | Standard Deviation 19.09 |
| Supportive Therapy | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Posttreatment | 8.17 Binge eating episodes | Standard Deviation 8.67 |
| Supportive Therapy | Binge Eating Frequency Assessed by the Eating Disorder Examination | Binge Eating Frequency at Mid-treatment | 13.07 Binge eating episodes | Standard Deviation 15.25 |
Primary
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Pretreatment | 5.62 Compensatory behavior episodes | Standard Deviation 7.6 |
| Reward Re-Training | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Posttreatment | 2.52 Compensatory behavior episodes | Standard Deviation 5.6 |
| Reward Re-Training | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Mid-treatment | 4.10 Compensatory behavior episodes | Standard Deviation 6.83 |
| Reward Re-Training | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at 3-month Follow-up | 1.91 Compensatory behavior episodes | Standard Deviation 5.28 |
| Supportive Therapy | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at 3-month Follow-up | 3.35 Compensatory behavior episodes | Standard Deviation 8.26 |
| Supportive Therapy | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Pretreatment | 6.20 Compensatory behavior episodes | Standard Deviation 12.03 |
| Supportive Therapy | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Mid-treatment | 4.02 Compensatory behavior episodes | Standard Deviation 7.57 |
| Supportive Therapy | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Compensatory Behavior Frequency at Posttreatment | 2.87 Compensatory behavior episodes | Standard Deviation 7.78 |
Primary
Global Eating Pathology
The Eating Disorder Examination is a semi-structured interview that measures eating. pathology. The EDE yields a total eating pathology score that will be used as an outcome variable. Global eating pathology is on a 0-6 point scale with higher scores indicating more significant eating pathology.
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Global Eating Pathology | EDE Global Score at Prettreatment | 2.72 score on a scale | Standard Deviation 0.91 |
| Reward Re-Training | Global Eating Pathology | EDE Global Score at Mid-treatment | 2.21 score on a scale | Standard Deviation 0.96 |
| Reward Re-Training | Global Eating Pathology | EDE Global Score at Posttreatment | 1.87 score on a scale | Standard Deviation 0.89 |
| Reward Re-Training | Global Eating Pathology | EDE Global Score at 3-month Follow-up | 1.43 score on a scale | Standard Deviation 0.93 |
| Supportive Therapy | Global Eating Pathology | EDE Global Score at 3-month Follow-up | 2.04 score on a scale | Standard Deviation 0.95 |
| Supportive Therapy | Global Eating Pathology | EDE Global Score at Prettreatment | 2.70 score on a scale | Standard Deviation 0.99 |
| Supportive Therapy | Global Eating Pathology | EDE Global Score at Posttreatment | 1.98 score on a scale | Standard Deviation 0.78 |
| Supportive Therapy | Global Eating Pathology | EDE Global Score at Mid-treatment | 2.10 score on a scale | Standard Deviation 0.96 |
Primary
Remission Status
A participant is considered to be in remission if they had no loss of control eating episodes or compensatory behaviors in the past 28 days, as well as an EDE global score less than 1.74 (which is within one standard deviation of community norms).
Time frame: Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reward Re-Training | Remission Status | Remission at Posstreatment | 4 Participants |
| Reward Re-Training | Remission Status | Remission at 3-month follow-up | 7 Participants |
| Supportive Therapy | Remission Status | Remission at Posstreatment | 1 Participants |
| Supportive Therapy | Remission Status | Remission at 3-month follow-up | 6 Participants |
Secondary
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
Assesses the type (description of certain feelings or attitudes) and intensity (how often or how much the feelings and attitudes are present) of various depressive symptoms using a total score. The scale ranges from 0-63 with higher scores indicating worse depressive symptoms.
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Pretreatment | 15.83 Score on a scale | Standard Deviation 11.1 |
| Reward Re-Training | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Mid-treatment | 10.19 Score on a scale | Standard Deviation 10.87 |
| Reward Re-Training | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Posttreatment | 9.57 Score on a scale | Standard Deviation 10.7 |
| Reward Re-Training | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at 3-month Follow-up | 7.94 Score on a scale | Standard Deviation 9.32 |
| Supportive Therapy | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at 3-month Follow-up | 17.02 Score on a scale | Standard Deviation 4.51 |
| Supportive Therapy | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Pretreatment | 18.87 Score on a scale | Standard Deviation 10.38 |
| Supportive Therapy | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Posttreatment | 13.30 Score on a scale | Standard Deviation 10.89 |
| Supportive Therapy | Depressive Symptoms as Assessed by the Beck Depression Inventory-II | BDI Score at Mid-treatment | 14.95 Score on a scale | Standard Deviation 8.75 |
Secondary
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
Assesses the importance of 16 given life domains have on influencing happiness and current satisfaction level regarding these 16 life domains. Scores range from 1-77 with higher scores indicating better quality of life.
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Pretreatment | 15.48 Score on a scale | Standard Deviation 1.96 |
| Reward Re-Training | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Mid-Treatment | 16.04 Score on a scale | Standard Deviation 1.5 |
| Reward Re-Training | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Posttreatment | 16.33 Score on a scale | Standard Deviation 1.6 |
| Reward Re-Training | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at 3-month Follow-up | 16.16 Score on a scale | Standard Deviation 1.84 |
| Supportive Therapy | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at 3-month Follow-up | 16.22 Score on a scale | Standard Deviation 1.99 |
| Supportive Therapy | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Pretreatment | 15.59 Score on a scale | Standard Deviation 2.11 |
| Supportive Therapy | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Posttreatment | 16.32 Score on a scale | Standard Deviation 1.89 |
| Supportive Therapy | Quality of Life Assessed by the Quality of Life Inventory (QOLI) | QOLI Scores at Mid-Treatment | 15.92 Score on a scale | Standard Deviation 2.04 |
Secondary
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of substance use (number of days/month) assessed by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST).
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reward Re-Training | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Pretreatment | 3.00 days/month | Standard Deviation 4.7 |
| Reward Re-Training | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Mid-treatment | 3.31 days/month | Standard Deviation 4.95 |
| Reward Re-Training | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Posttreatment | 2.93 days/month | Standard Deviation 6.29 |
| Reward Re-Training | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at 3-month Follow-up | 2.90 days/month | Standard Deviation 5.64 |
| Supportive Therapy | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at 3-month Follow-up | 2.57 days/month | Standard Deviation 4.57 |
| Supportive Therapy | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Pretreatment | 2.83 days/month | Standard Deviation 4 |
| Supportive Therapy | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Posttreatment | 2.03 days/month | Standard Deviation 3.7 |
| Supportive Therapy | Substance Use Assessed by the NIDA-Modified ASSIST | Frequency of Substance Use at Mid-treatment | 2.50 days/month | Standard Deviation 3.7 |