N/A N=59 Randomized Single-blind Treatment

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

Bulimia Nervosa · Bulimia; Atypical · Binge Eating · Binge-Eating Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04661410 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Binge Eating Frequency Assessed by the Eating Disorder Examination — 25.10; 25.27; 9.19; 13.07 Binge eating episodes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reward Re-Training (Behavioral); Supportive Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Drexel University
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Binge Eating Frequency Assessed by the Eating Disorder Examination	25.10; 25.27; 9.19; 13.07; 8.94; 8.17	—
PRIMARY Global Eating Pathology	2.72; 2.70; 2.21; 2.10; 1.87; 1.98	—
PRIMARY Remission Status	4; 1; 7; 6	—
PRIMARY Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)	5.62; 6.20; 4.10; 4.02; 2.52; 2.87	—
SECONDARY Depressive Symptoms as Assessed by the Beck Depression Inventory-II	15.83; 18.87; 10.19; 14.95; 9.57; 13.30	—
SECONDARY Substance Use Assessed by the NIDA-Modified ASSIST	3.00; 2.83; 3.31; 2.50; 2.93; 2.03	—
SECONDARY Quality of Life Assessed by the Quality of Life Inventory (QOLI)	15.48; 15.59; 16.04; 15.92; 16.33; 16.32	—

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04661410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.