Trial Outcomes & Findings for Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic (NCT NCT04661410)
NCT ID: NCT04661410
Last Updated: 2024-03-21
Results Overview
Frequency (number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
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 posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Baseline characteristics by cohort
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.79 years
STANDARD_DEVIATION 13.30 • n=5 Participants
|
40.37 years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
40.58 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Baseline EDE Global Score
|
2.72 Scores on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
2.70 Scores on a scale
STANDARD_DEVIATION 0.99 • n=7 Participants
|
2.71 Scores on a scale
STANDARD_DEVIATION 0.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Binge Eating Frequency Assessed by the Eating Disorder Examination
Binge Eating Frequency at Pretreatment
|
25.10 Binge eating episodes
Standard Deviation 22.56
|
25.27 Binge eating episodes
Standard Deviation 19.09
|
|
Binge Eating Frequency Assessed by the Eating Disorder Examination
Binge Eating Frequency at Mid-treatment
|
9.19 Binge eating episodes
Standard Deviation 13.95
|
13.07 Binge eating episodes
Standard Deviation 15.25
|
|
Binge Eating Frequency Assessed by the Eating Disorder Examination
Binge Eating Frequency at Posttreatment
|
8.94 Binge eating episodes
Standard Deviation 12.10
|
8.17 Binge eating episodes
Standard Deviation 8.67
|
|
Binge Eating Frequency Assessed by the Eating Disorder Examination
Binge Eating Frequency at 3-month Follow-up
|
6.38 Binge eating episodes
Standard Deviation 16.77
|
4.35 Binge eating episodes
Standard Deviation 6.54
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Global Eating Pathology
EDE Global Score at Prettreatment
|
2.72 score on a scale
Standard Deviation 0.91
|
2.70 score on a scale
Standard Deviation 0.99
|
|
Global Eating Pathology
EDE Global Score at Mid-treatment
|
2.21 score on a scale
Standard Deviation 0.96
|
2.10 score on a scale
Standard Deviation 0.96
|
|
Global Eating Pathology
EDE Global Score at Posttreatment
|
1.87 score on a scale
Standard Deviation 0.89
|
1.98 score on a scale
Standard Deviation 0.78
|
|
Global Eating Pathology
EDE Global Score at 3-month Follow-up
|
1.43 score on a scale
Standard Deviation 0.93
|
2.04 score on a scale
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Remission Status
Remission at Posstreatment
|
4 Participants
|
1 Participants
|
|
Remission Status
Remission at 3-month follow-up
|
7 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Compensatory Behavior Frequency at Pretreatment
|
5.62 Compensatory behavior episodes
Standard Deviation 7.60
|
6.20 Compensatory behavior episodes
Standard Deviation 12.03
|
|
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Compensatory Behavior Frequency at Mid-treatment
|
4.10 Compensatory behavior episodes
Standard Deviation 6.83
|
4.02 Compensatory behavior episodes
Standard Deviation 7.57
|
|
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Compensatory Behavior Frequency at Posttreatment
|
2.52 Compensatory behavior episodes
Standard Deviation 5.60
|
2.87 Compensatory behavior episodes
Standard Deviation 7.78
|
|
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
Compensatory Behavior Frequency at 3-month Follow-up
|
1.91 Compensatory behavior episodes
Standard Deviation 5.28
|
3.35 Compensatory behavior episodes
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.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.
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
BDI Score at Pretreatment
|
15.83 Score on a scale
Standard Deviation 11.10
|
18.87 Score on a scale
Standard Deviation 10.38
|
|
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
BDI Score at Mid-treatment
|
10.19 Score on a scale
Standard Deviation 10.87
|
14.95 Score on a scale
Standard Deviation 8.75
|
|
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
BDI Score at Posttreatment
|
9.57 Score on a scale
Standard Deviation 10.70
|
13.30 Score on a scale
Standard Deviation 10.89
|
|
Depressive Symptoms as Assessed by the Beck Depression Inventory-II
BDI Score at 3-month Follow-up
|
7.94 Score on a scale
Standard Deviation 9.32
|
17.02 Score on a scale
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: 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 of substance use (number of days/month) assessed by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST).
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of Substance Use at Pretreatment
|
3.00 days/month
Standard Deviation 4.70
|
2.83 days/month
Standard Deviation 4.00
|
|
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of Substance Use at Mid-treatment
|
3.31 days/month
Standard Deviation 4.95
|
2.50 days/month
Standard Deviation 3.70
|
|
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of Substance Use at Posttreatment
|
2.93 days/month
Standard Deviation 6.29
|
2.03 days/month
Standard Deviation 3.70
|
|
Substance Use Assessed by the NIDA-Modified ASSIST
Frequency of Substance Use at 3-month Follow-up
|
2.90 days/month
Standard Deviation 5.64
|
2.57 days/month
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.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.
Outcome measures
| Measure |
Reward Re-Training
n=29 Participants
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.
|
Supportive Therapy
n=30 Participants
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.
|
|---|---|---|
|
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
QOLI Scores at Pretreatment
|
15.48 Score on a scale
Standard Deviation 1.96
|
15.59 Score on a scale
Standard Deviation 2.11
|
|
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
QOLI Scores at Mid-Treatment
|
16.04 Score on a scale
Standard Deviation 1.50
|
15.92 Score on a scale
Standard Deviation 2.04
|
|
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
QOLI Scores at Posttreatment
|
16.33 Score on a scale
Standard Deviation 1.60
|
16.32 Score on a scale
Standard Deviation 1.89
|
|
Quality of Life Assessed by the Quality of Life Inventory (QOLI)
QOLI Scores at 3-month Follow-up
|
16.16 Score on a scale
Standard Deviation 1.84
|
16.22 Score on a scale
Standard Deviation 1.99
|
Adverse Events
Reward Re-Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place