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

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).

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder; Bulimia Nervosa; Binge Eating; Bulimia; Atypical
• Intervention / Treatment: Behavioral: Reward Re-Training; Behavioral: Supportive Therapy

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University, Stratton Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reward Re-Training; 10 weekly sessions of Reward Re-Training Group Therapy.	Behavioral: 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.
Active Comparator: Supportive Therapy; 10 weekly sessions of Supportive Group Therapy.	Behavioral: 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.

What is the study measuring?

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	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 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.	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
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).	Each assessment time point after treatment completion (Posttreatment (Week 10) and a 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	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 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.	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
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).	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 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.	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Juarascio AS, Michael ML, Srivastava P, Manasse SM, Drexler S, Felonis CR. The Reward Re-Training protocol: A novel intervention approach designed to alter the reward imbalance contributing to binge eating during COVID-19. Int J Eat Disord. 2021 Jul;54(7):1316-1322. doi: 10.1002/eat.23528. Epub 2021 Apr 28.

Helpful Links

• For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Bulimia Nervosa; Binge Eating; Eating Disorders; Supportive Psychotherapy; Binge Eating Disorder; Reward Re-training
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Digestive; Hyperphagia; COVID-19; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 2009008088; R01MH122392-01S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No