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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH122392-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reward Re-Training | Experimental | 10 weekly sessions of Reward Re-Training Group Therapy. |
|
| Supportive Therapy | Active Comparator | 10 weekly sessions of Supportive Group Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reward Re-Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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). | 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 | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University, Stratton Hall | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101915 | Derived | 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. | |
| 33908655 | Derived | Juarascio 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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| ID | Title | Description |
|---|---|---|
| FG000 | Reward Re-Training | 10 weekly sessions of Reward Re-Training Group Therapy. Reward Re-Training: 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. |
| FG001 | Supportive Therapy | 10 weekly sessions of Supportive Group Therapy. Supportive Therapy: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reward Re-Training | 10 weekly sessions of Reward Re-Training Group Therapy. Reward Re-Training: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Binge eating episodes | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reward Re-Training | 10 weekly sessions of Reward Re-Training Group Therapy. Reward Re-Training: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adrienne Juarascio | The WELL Center | 443-801-8093 | asj32@drexel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | Dec 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Dec 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| D056912 | Binge-Eating Disorder |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Supportive Therapy | Behavioral | 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. |
|
| 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). | 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. | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
| BG001 | Supportive Therapy | 10 weekly sessions of Supportive Group Therapy. Supportive Therapy: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline EDE Global Score | The Eating Disorder Examination (EDE) is a diagnostic interview for the assessment of eating disorder symptoms, including binge eating frequency, compensatory behavior frequency, and global eating pathology. The EDE yields a global score and four subscale scores (Restraint, Eating concern, Shape concern, Weight concern), with higher scores indicating greater severity of eating disorder pathology. To obtain the global score, the subscale scores (which range from 0 to 6) are summed, and the resulting total is divided by the number of subscales (i.e. four). | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Supportive Therapy | 10 weekly sessions of Supportive Group Therapy. Supportive Therapy: 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment). |
|
|
|
| Primary | Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE) | Frequency ( number of instances) of compensatory behaviors assessed by the Eating Disorder Examination | Posted | Mean | Standard Deviation | Compensatory behavior episodes | 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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 | 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). | Posted | Mean | Standard Deviation | days/month | 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment. |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Supportive Therapy | 10 weekly sessions of Supportive Group Therapy. Supportive Therapy: 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| EDE Global Score at Posttreatment |
|
| EDE Global Score at 3-month Follow-up |
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| Compensatory Behavior Frequency at Posttreatment |
|
| Compensatory Behavior Frequency at 3-month Follow-up |
|
| BDI Score at Posttreatment |
|
| BDI Score at 3-month Follow-up |
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| Frequency of Substance Use at Posttreatment |
|
| Frequency of Substance Use at 3-month Follow-up |
|
| QOLI Scores at Posttreatment |
|
| QOLI Scores at 3-month Follow-up |
|