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

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT04661410

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

9.5

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Bulimia Nervosa Bulimia; Atypical Binge Eating Binge-Eating Disorder	Behavioral: Reward Re-Training Behavioral: Supportive Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Sep 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Binge eating frequency 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]
Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Global Eating Pathology [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 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.
Remission Status [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment]
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) [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment]
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 [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 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 [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 3-month post-treatment follow-up assessment]
Frequency of substance use (number of days/month)
Quality of Life assessed by the Quality of Life Inventory (QOLI) [Changes from each assessment time point throughout treatment (3 assessments over 10 weeks) and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)