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

Bulimia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661410
• Other study ID #: 2009008088
• Secondary ID: R01MH122392-01S1
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: March 2024
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Bulimia; Atypical
• COVID-19
• Feeding and Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Drexel University, Stratton Hall	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
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.	Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
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).	Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment).
Primary	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	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.
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).	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	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.

External Links

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