Bulimia NervosaNCT04661410
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
A study testing Reward Re-Training and Supportive Therapy in people with Bulimia Nervosa and Bulimia; Atypical, run by Drexel University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa, Bulimia; Atypical, Binge Eating
- What is being tested?
- Reward Re-Training and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI above 18.5
- Are located in the US and willing/able to participate in remote treatment and assessments
- Are able to give consent
Who cannot join
- Are unable to fluently speak, write and read English
- Have a BMI below 18.5
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University, Stratton Hall
Philadelphia, Pennsylvania, 19104
About this study
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).
- Being tested
- Reward Re-Training, Supportive Therapy
- Keywords
- Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy
- Medical subject headings
- Bulimia Nervosa, Bulimia, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reward Re-TrainingBehavioural
A brief, 10-session group-based behavioral treatment that is designed to indirectly change binge eating by directly focusing on building a more rewarding life. RRT hypothesizes that reductions in binge eating will occur as life becomes more rewarding because individuals will no longer need to rely on binge eating as a primary source of momentary reward. RRT notes that in order to live a satisfying life, individuals need to experience an adequate amount of reward in two overlapping yet distinguishable domains: momentary reward (i.e., the active experience of pleasure in the moment) and sustained reward (i.e., a deeper and more long-lasting sense of fulfillment and meaning that arises from building a personally valued life). A key aspect of RRT is an emphasize on building lasting and meaningful social relationships given the clear evidence that social connectedness can enhance both momentary reward and sustained reward.
Supportive TherapyBehavioural
A brief, 10-session group-based treatment that is designed to instill hope and optimism and to increase social connection and support through a non-directive group leader that allows the patients to determine the focus of each session. The group leader will act as an empathetic provider by using reflective listening, eliciting and validating affect, and offering empathic comments.
| Study group | Role | What they receive |
|---|---|---|
| Reward Re-Training | Experimental | 10 weekly sessions of Reward Re-Training Group Therapy. Receives: Behavioral: Reward Re-Training |
| Supportive Therapy | Active comparator | 10 weekly sessions of Supportive Group Therapy. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Frequency Assessed by the Eating Disorder Examination
Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Global Eating Pathology
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.
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Remission Status
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).
Measured: Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment).
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Secondary outcomes (3)
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
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.
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of substance use (number of days/month) assessed by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST).
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
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.
Measured: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Dec 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661410
- Sponsor's protocol ID
- 2009008088
- Other IDs
- R01MH122392-01S1
- Status last verified
- Mar 2024
- First submitted
- 7 Dec 2020
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
LaFata EM, Worwag K, Derrigo K, Hessler C, Allison KC, Juarascio AS, Gearhardt AN. Development of the Food Addiction Symptom Inventory: The first clinical interview to assess ultra-processed food addiction. Psychol Assess. 2024 Nov;36(11):654-664. doi: 10.1037/pas0001340. Epub 2024 Aug 5.
PubMed 39101915Juarascio AS, Michael ML, Srivastava P, Manasse SM, Drexler S, Felonis CR. The Reward Re-Training protocol: A novel intervention approach designed to alter the reward imbalance contributing to binge eating during COVID-19. Int J Eat Disord. 2021 Jul;54(7):1316-1322. doi: 10.1002/eat.23528. Epub 2021 Apr 28.
PubMed 33908655
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04661410
- Acronym / sponsor ID
- 2009008088
- Keywords
- Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Binge Eating, Reward Re-training, Supportive Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reward Re-Training | Experimental | Behavioral: Reward Re-Training10 weekly sessions of Reward Re-Training Group Therapy. |
| Supportive Therapy | Active comparator | Behavioral: Supportive Therapy10 weekly sessions of Supportive Group Therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI above 18.5
- Are located in the US and willing/able to participate in remote treatment and assessments
- Are able to give consent
Key exclusion criteria (5 listed)
- Are unable to fluently speak, write and read English
- Have a BMI below 18.5
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
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 |
|---|---|---|
| Reward Re-TrainingA brief, 10-session group-based behavioral treatment that is designed to indirectly change binge eating by directly focusing on building a more rewarding life. RRT hypothesizes that reductions in binge eating will occur as life becomes more rewarding because individuals will no longer need to rely on binge eating as a primary source of momentary reward. RRT notes that in order to live a satisfying life, individuals need to experience an adequate amount of reward in two overlapping yet distinguishable domains: momentary reward (i.e., the active experience of pleasure in the moment) and sustained reward (i.e., a deeper and more long-lasting sense of fulfillment and meaning that arises from building a personally valued life). A key aspect of RRT is an emphasize on building lasting and meaningful social relationships given the clear evidence that social connectedness can enhance both momentary reward and sustained reward. | Behavioural | Reward Re-Training |
| Supportive TherapyA brief, 10-session group-based treatment that is designed to instill hope and optimism and to increase social connection and support through a non-directive group leader that allows the patients to determine the focus of each session. The group leader will act as an empathetic provider by using reflective listening, eliciting and validating affect, and offering empathic comments. | Behavioural | Supportive Therapy |
Primary outcome
Binge Eating Frequency Assessed by the Eating Disorder Examination
Time frame: 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
Global Eating Pathology
Time frame: 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.
Remission Status
Time frame: 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).
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Time frame: 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
3 secondary outcomes
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Substance Use Assessed by the NIDA-Modified ASSIST
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
Time frame: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39101915LaFata EM, Worwag K, Derrigo K, Hessler C, Allison KC, Juarascio AS, Gearhardt AN. Development of the Food Addiction Symptom Inventory: The first clinical interview to assess ultra-processed food addiction. Psychol Assess. 2024 Nov;36(11):654-664. doi: 10.1037/pas0001340. Epub 2024 Aug 5.
- Derived from this study: PubMed 33908655Juarascio AS, Michael ML, Srivastava P, Manasse SM, Drexler S, Felonis CR. The Reward Re-Training protocol: A novel intervention approach designed to alter the reward imbalance contributing to binge eating during COVID-19. Int J Eat Disord. 2021 Jul;54(7):1316-1322. doi: 10.1002/eat.23528. Epub 2021 Apr 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reward Re-Training and Supportive Therapy in people with Bulimia Nervosa and Bulimia; Atypical, 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 4 inclusion and 5 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 21 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Binge Eating Frequency Assessed by the Eating Disorder Examination (time frame: 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 study lists 4 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 NCT04661410, which also lists 2 linked publications.
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 21 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.