NCT03942874

Brief Summary

The purpose of this study is to test a novel treatment for binge eating that will be compared to a waitlist control group. The investigators are seeking to target factors that might influence binge eating by increasing reward in non-food life domains. The treatment is weekly for 10 weeks and will take place at Drexel University in Philadelphia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

April 25, 2019

Last Update Submit

September 21, 2021

Conditions

Keywords

rewardreward dysfunctiongroup treatmentbinge eating

Outcome Measures

Primary Outcomes (2)

  • Feedback Questionnaire (FQ)

    The feedback questionnaire asks qualitative questions about the quality of and satisfaction with the treatment. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings.

    Assessed at mid- and post- treatment sessions (3 months)

  • Binge frequency assessed by the Eating Disorder Examination

    Frequency (number of days and number of instances) of binge eating behaviors over the past 28 days assessed by the Eating Disorder Examination

    Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment)

Secondary Outcomes (1)

  • Reward responsivity to natural (nonfood) reward- Reward Probability Index (RPI)

    Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment)

Study Arms (2)

Treatment

EXPERIMENTAL

Participants will complete baseline sessions and then complete treatment right away.

Behavioral: Group Reward Retraining

Waitlist Control

EXPERIMENTAL

Participants will complete a baseline session and then wait for 10 weeks before starting treatment.

Behavioral: Group Reward Retraining

Interventions

Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated

Also known as: behavioral activation
TreatmentWaitlist Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically significant binge eating

You may not qualify if:

  • non-removable metal object in body
  • non-removable hair extensions or wig
  • tattoo above shoulders
  • significant amounts of metal fillings in mouth
  • BMI below 18.5
  • BMI above 40
  • Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder)
  • Are unable to fluently speak, write and read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel WELL Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Juarascio AS, Presseller EK, Wilkinson ML, Kelkar A, Srivastava P, Chen JY, Dengler J, Manasse SM, Medaglia J. Correcting the reward imbalance in binge eating: A pilot randomized trial of reward re-training treatment. Appetite. 2022 Sep 1;176:106103. doi: 10.1016/j.appet.2022.106103. Epub 2022 Jun 1.

MeSH Terms

Conditions

BulimiaBinge-Eating DisorderBulimia Nervosa

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Officials

  • Adrienne Juarascio, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 8, 2019

Study Start

April 24, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations