Binge EatingRechargeNCT03942874
Development and Initial Tests of Reward Re-Training: A Novel Treatment For Reward Dysfunction
A study testing Group Reward Retraining in people with Binge Eating and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating, Binge-Eating Disorder, Bulimia Nervosa
- What is being tested?
- Group Reward Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically significant binge eating
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel WELL Center
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Binge Eating, Binge-Eating Disorder, Bulimia Nervosa
- Being tested
- Group Reward Retraining
- Keywords
- reward, reward dysfunction, group treatment, binge eating
- Medical subject headings
- Bulimia, Binge-Eating Disorder, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Reward RetrainingBehavioural
Also called behavioral activation
Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will complete baseline sessions and then complete treatment right away. Receives: Behavioral: Group Reward Retraining |
| Waitlist Control | Experimental | Participants will complete a baseline session and then wait for 10 weeks before starting treatment. Receives: Behavioral: Group Reward Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
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.
Measured: Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start24 Apr 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Juarascio, Drexel University
- Investigators
- Adrienne Juarascio, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942874
- Sponsor's protocol ID
- Project Recharge
- Acronym
- Recharge
- Status last verified
- Sep 2021
- First submitted
- 25 Apr 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35662619
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Initial Tests of Reward Re-Training: A Novel Treatment For Reward Dysfunction
- ClinicalTrials.gov ID
- NCT03942874
- Acronym / sponsor ID
- Recharge / Project Recharge
- Conditions
- Binge Eating, Binge-Eating Disorder, Bulimia Nervosa
- Keywords
- reward, reward dysfunction, group treatment, binge eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Group Reward RetrainingParticipants will complete baseline sessions and then complete treatment right away. |
| Waitlist Control | Experimental | Behavioral: Group Reward RetrainingParticipants will complete a baseline session and then wait for 10 weeks before starting treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinically significant binge eating
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Reward RetrainingAlso: behavioral activationAdapted behavioral activation group treatment for binge eating with values and cognitive skills integrated | Behavioural | Treatment, Waitlist Control |
Primary outcome
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.
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 35662619Juarascio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Juarascio, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Reward Retraining in people with Binge Eating and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback Questionnaire (FQ) (time frame: Assessed at mid- and post- treatment sessions (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.