Last reviewed · How we verify

NCT04661410

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

Completed NA Results posted Last updated 21 March 2024
What this trial tests

NA trial testing Reward Re-Training in Bulimia Nervosa in 59 participants. Completed in 15 September 2021.

Timeline
1 December 2020
Primary endpoint
15 September 2021
15 September 2021

Quick facts

Lead sponsorDrexel University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment59
Start date1 December 2020
Primary completion15 September 2021
Estimated completion15 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Drexel University

Who can join

Adults 18 to 65, any sex, with Bulimia Nervosa or Bulimia; Atypical. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binge Eating Frequency Assessed by the Eating Disorder Examination Primary · 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

Binge Eating Frequency at Pretreatment
GroupValue95% CI
Reward Re-Training25.10± 22.56
Supportive Therapy25.27± 19.09
Binge Eating Frequency at Mid-treatment
GroupValue95% CI
Reward Re-Training9.19± 13.95
Supportive Therapy13.07± 15.25
Binge Eating Frequency at Posttreatment
GroupValue95% CI
Reward Re-Training8.94± 12.10
Supportive Therapy8.17± 8.67
Binge Eating Frequency at 3-month Follow-up
GroupValue95% CI
Reward Re-Training6.38± 16.77
Supportive Therapy4.35± 6.54
Global Eating Pathology Primary · 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.

EDE Global Score at Prettreatment
GroupValue95% CI
Reward Re-Training2.72± 0.91
Supportive Therapy2.70± 0.99
EDE Global Score at Mid-treatment
GroupValue95% CI
Reward Re-Training2.21± 0.96
Supportive Therapy2.10± 0.96
EDE Global Score at Posttreatment
GroupValue95% CI
Reward Re-Training1.87± 0.89
Supportive Therapy1.98± 0.78
EDE Global Score at 3-month Follow-up
GroupValue95% CI
Reward Re-Training1.43± 0.93
Supportive Therapy2.04± 0.95
Remission Status Primary · 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).

Remission at Posstreatment
GroupValue95% CI
Reward Re-Training4
Supportive Therapy1
Remission at 3-month follow-up
GroupValue95% CI
Reward Re-Training7
Supportive Therapy6
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) Primary · 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

Compensatory Behavior Frequency at Pretreatment
GroupValue95% CI
Reward Re-Training5.62± 7.60
Supportive Therapy6.20± 12.03
Compensatory Behavior Frequency at Mid-treatment
GroupValue95% CI
Reward Re-Training4.10± 6.83
Supportive Therapy4.02± 7.57
Compensatory Behavior Frequency at Posttreatment
GroupValue95% CI
Reward Re-Training2.52± 5.60
Supportive Therapy2.87± 7.78
Compensatory Behavior Frequency at 3-month Follow-up
GroupValue95% CI
Reward Re-Training1.91± 5.28
Supportive Therapy3.35± 8.26
Depressive Symptoms as Assessed by the Beck Depression Inventory-II Secondary · 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.

BDI Score at Pretreatment
GroupValue95% CI
Reward Re-Training15.83± 11.10
Supportive Therapy18.87± 10.38
BDI Score at Mid-treatment
GroupValue95% CI
Reward Re-Training10.19± 10.87
Supportive Therapy14.95± 8.75
BDI Score at Posttreatment
GroupValue95% CI
Reward Re-Training9.57± 10.70
Supportive Therapy13.30± 10.89
BDI Score at 3-month Follow-up
GroupValue95% CI
Reward Re-Training7.94± 9.32
Supportive Therapy17.02± 4.51
Substance Use Assessed by the NIDA-Modified ASSIST Secondary · 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).

Frequency of Substance Use at Pretreatment
GroupValue95% CI
Reward Re-Training3.00± 4.70
Supportive Therapy2.83± 4.00
Frequency of Substance Use at Mid-treatment
GroupValue95% CI
Reward Re-Training3.31± 4.95
Supportive Therapy2.50± 3.70
Frequency of Substance Use at Posttreatment
GroupValue95% CI
Reward Re-Training2.93± 6.29
Supportive Therapy2.03± 3.70
Frequency of Substance Use at 3-month Follow-up
GroupValue95% CI
Reward Re-Training2.90± 5.64
Supportive Therapy2.57± 4.57
Quality of Life Assessed by the Quality of Life Inventory (QOLI) Secondary · 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.

QOLI Scores at Pretreatment
GroupValue95% CI
Reward Re-Training15.48± 1.96
Supportive Therapy15.59± 2.11
QOLI Scores at Mid-Treatment
GroupValue95% CI
Reward Re-Training16.04± 1.50
Supportive Therapy15.92± 2.04
QOLI Scores at Posttreatment
GroupValue95% CI
Reward Re-Training16.33± 1.60
Supportive Therapy16.32± 1.89
QOLI Scores at 3-month Follow-up
GroupValue95% CI
Reward Re-Training16.16± 1.84
Supportive Therapy16.22± 1.99

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development of the Food Addiction Symptom Inventory: The first clinical interview to assess ultra-processed food addiction.
    LaFata EM, Worwag K, Derrigo K, Hessler C, et al · · 2024 · cited 8× · PMID 39101915 · DOI 10.1037/pas0001340
  2. The Reward Re-Training protocol: A novel intervention approach designed to alter the reward imbalance contributing to binge eating during COVID-19.
    Juarascio AS, Michael ML, Srivastava P, Manasse SM, et al · · 2021 · cited 7× · PMID 33908655 · DOI 10.1002/eat.23528

Verify or expand the search:

Other recruiting trials for Bulimia Nervosa

Currently open trials in the same condition.

Other Drexel University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04661410.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing