Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Primary Purpose
Bulimia Nervosa, Bulimia; Atypical, Binge Eating
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reward Re-Training
Supportive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy
Eligibility Criteria
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)
Sites / Locations
- Drexel University, Stratton Hall
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reward Re-Training
Supportive Therapy
Arm Description
10 weekly sessions of Reward Re-Training Group Therapy.
10 weekly sessions of Supportive Group Therapy.
Outcomes
Primary Outcome Measures
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
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.
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Secondary Outcome Measures
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.
Substance Use assessed by the NIDA-Modified ASSIST
Frequency of substance use (number of days/month)
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.
Full Information
NCT ID
NCT04661410
First Posted
December 7, 2020
Last Updated
March 23, 2022
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04661410
Brief Title
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Official Title
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Bulimia; Atypical, Binge Eating, Binge-Eating Disorder
Keywords
Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reward Re-Training
Arm Type
Experimental
Arm Description
10 weekly sessions of Reward Re-Training Group Therapy.
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
10 weekly sessions of Supportive Group Therapy.
Intervention Type
Behavioral
Intervention Name(s)
Reward Re-Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge eating frequency assessed by the Eating Disorder Examination
Description
Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Title
Global Eating Pathology
Description
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
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Title
Remission Status
Description
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Title
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Description
Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Secondary Outcome Measure Information:
Title
Depressive symptoms as assessed by the Beck Depression Inventory-II
Description
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
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Title
Substance Use assessed by the NIDA-Modified ASSIST
Description
Frequency of substance use (number of days/month)
Time Frame
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
Title
Quality of Life assessed by the Quality of Life Inventory (QOLI)
Description
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
Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Drexel University, Stratton Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33908655
Citation
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.
Results Reference
derived
Links:
URL
https://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/
Description
For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu.
Learn more about this trial
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
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