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

Not Applicable

Completed

• Conditions: Binge-Eating Disorder; Bulimia; Atypical; Binge Eating; Bulimia Nervosa
• Interventions: Behavioral: Reward Re-Training; Behavioral: Supportive Therapy

• Registration Number: NCT04661410
• Lead Sponsor: Drexel University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Results First Submitted: 2022-12-02
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Results First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reward Re-Training	Reward Re-Training	10 weekly sessions of Reward Re-Training Group Therapy.
Supportive Therapy	Supportive Therapy	10 weekly sessions of Supportive Group Therapy.

Primary Outcome Measures

Name	Time	Method
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.
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
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).

Secondary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Drexel University, Stratton Hall; 🇺🇸 Philadelphia, Pennsylvania, United States