- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942874
Development and Initial Tests of Reward Re-Training: A Novel Treatment For Reward Dysfunction (Recharge)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel WELL Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
Participants will complete baseline sessions and then complete treatment right away.
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Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
Other Names:
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EXPERIMENTAL: Waitlist Control
Participants will complete a baseline session and then wait for 10 weeks before starting treatment.
|
Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feedback Questionnaire (FQ)
Time Frame: Assessed at mid- and post- treatment sessions (3 months)
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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.
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Assessed at mid- and post- treatment sessions (3 months)
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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)
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Frequency (number of days and number of instances) of binge eating behaviors over the past 28 days assessed by the Eating Disorder Examination
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Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline assessment (before beginning treatment) to post-treatment assessment (10 weeks after baseline assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrienne Juarascio, PhD, Drexel University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Project Recharge
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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