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Development and Initial Tests of Reward Re-Training: A Novel Treatment For Reward Dysfunction (Recharge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942874
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Adrienne Juarascio, Drexel University

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.

Condition or disease Intervention/treatment Phase
Binge Eating Binge-Eating Disorder Bulimia Nervosa Behavioral: Group Reward Retraining Not Applicable

Detailed Description:

At the start of the study, you will be interviewed to determine if you are eligible to participate in the study.

Once you are determined to be eligible, you will be assigned at random to a treatment group or a waitlist control group. The chances of being assigned to each condition are like a flip of a coin. If you are placed in the waitlist control group, you will complete a 10-week waiting period after your initial assessment, then complete another assessment and treatment after 10 weeks.

First, the study will be explained to you and you will be given an opportunity to ask questions about the study and sign this consent form.

You will complete the baseline assessment, which will take place in 2 sessions. The first session will take place at Drexel and will include behavioral tasks and surveys. The second session will take place at Temple University and will include an fMRI (functional magnetic resonance imaging) scan. Both sessions combined will take about 6 hours total. This baseline assessment will involve: Behavioral tasks: These are designed to measure your responses to food reward and other pleasant events. These tasks will be in the form of computer games where you will rate and sort different rewarding items. These will take place at Drexel University. Surveys: questions regarding demographics, disordered eating, weight history, and other psychological symptoms. These will take place at home if you choose to complete them before your assessment, or at Drexel University. fMRI task: fMRI scans will take place at Temple University. After consenting, an fMRI technician will review the safety checklist to make sure you have no metal objects in your clothing or on your body that might enter the scanner. Following this review, you will be taken to the MRI scanner. The scan will take about 1-hour. You will be asked to lie on your back on the scanner bed. You will be fit with a set of headphones, a microphone and goggles that are connected to a computer display. You will have continuous contact with the research team using the headphone and microphone. At any time during scanning, you can ask to be taken out of the scanner. The study involves lying quietly in the scanner, viewing pictures and hearing sounds while selecting answers to questions presented on the computer display. The scanning will also include a structural scan. If the computer procedures work well, the entire scanning session should last no longer than 60 minutes. Even if the scanning is not complete, you will be taken out of the scanner after 60 minutes.

You can expect to interact in group therapy with other study participants, led by Drexel faculty and graduate students in private rooms at the Psychology Department of Drexel University. You will receive 10 sessions of weekly group treatment that are each approximately one hour in length. You will complete the same assessment procedure you completed at the beginning of treatment at mid-treatment (after session 5-with the exception of the fMRI tasks) and post-treatment (after session 10). All sessions and assessments will be audio-recorded and securely stored until the completion of study analyses. If you do not wish to be audio-recorded, you may not participate in the study. If you are withdrawn from the study and wish for your recordings to be deleted, you may request that the researchers delete them.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Initial Tests of Reward Re-Training: A Novel Treatment For Reward Dysfunction
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Treatment
Participants will complete baseline sessions and then complete treatment right away.
Behavioral: Group Reward Retraining
Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
Other Name: behavioral activation

Experimental: Waitlist Control
Participants will complete a baseline session and then wait for 10 weeks before starting treatment.
Behavioral: Group Reward Retraining
Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
Other Name: behavioral activation




Primary Outcome Measures :
  1. Feedback Questionnaire (FQ) [ Time Frame: Assessed at mid- and post- treatment sessions (3 months) ]
    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.

  2. Binge frequency assessed by the Eating Disorder Examination [ Time Frame: Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment) ]
    Frequency (number of days and number of instances) of binge eating behaviors over the past 28 days assessed by the Eating Disorder Examination


Secondary Outcome Measures :
  1. Reward responsivity to natural (nonfood) reward- Reward Probability Index (RPI) [ Time Frame: Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment) ]
    The Reward Probability Index is a 20-item self-report measure of reward. The measure yields a total score. The total score is computed by summing responses, so the possible score range is 20 to 80. For the total score, higher scores indicate greater reward. The RPI will be used to assess increase in responsivity to nonfood reward.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically significant binge eating

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942874


Locations
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United States, Pennsylvania
Drexel WELL Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University
Investigators
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Principal Investigator: Adrienne Juarascio, PhD Drexel University

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Responsible Party: Adrienne Juarascio, Assistant Professor, Drexel University
ClinicalTrials.gov Identifier: NCT03942874     History of Changes
Other Study ID Numbers: Project Recharge
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrienne Juarascio, Drexel University:
reward
reward dysfunction
group treatment
binge eating
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms