Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic

Study Overview
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Brief Summary
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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).

Official Title
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Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic

Conditions
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Bulimia Nervosa, Bulimia; Atypical, Binge Eating, Binge-Eating Disorder

Intervention / Treatment
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* Behavioral: Reward Re-Training
* Behavioral: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have experienced 12 or more loss of control episodes within the previous 3 months Have a BMI above 18.5 Are located in the US and willing/able to participate in remote treatment and assessments Are able to give consent Exclusion Criteria: Are unable to fluently speak, write and read English Have a BMI below 18.5 Are receiving treatment for an eating disorder Require immediate treatment for medical complications as a result of eating disorder symptoms 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reward Re-Training<br>10 weekly sessions of Reward Re-Training Group Therapy. | Behavioral: Reward Re-Training<br>* 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.<br>|
| Active Comparator: Supportive Therapy<br>10 weekly sessions of Supportive Group Therapy. | Behavioral: Supportive Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 
| 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. | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 
| Remission Status | Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission. | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 
| Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE) | Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 
| Substance Use assessed by the NIDA-Modified ASSIST | Frequency of substance use (number of days/month) | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 
| 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. | Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy