Clinical trial NCT04661410: Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Official title: Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Bulimia; Atypical
Binge Eating
Binge-Eating Disorder
Keywords: Eating Disorders
Bulimia Nervosa
Binge Eating Disorder
Binge Eating
Reward Re-training
Supportive Psychotherapy
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-12-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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).


Eligibility criteria: Inclusion Criteria:

1. Have experienced 12 or more loss of control episodes within the previous 3 months
2. Have a BMI above 18.5
3. Are located in the US and willing/able to participate in remote treatment and assessments
4. Are able to give consent

Exclusion Criteria:

1. Are unable to fluently speak, write and read English
2. Have a BMI below 18.5
3. Are receiving treatment for an eating disorder
4. Require immediate treatment for medical complications as a result of eating disorder symptoms
5. 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)

Primary outcomes:
measure: Binge Eating Frequency Assessed by the Eating Disorder Examination
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.
measure: Global Eating Pathology
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.
measure: Remission Status
timeFrame: Each assessment time point after treatment completion (Posttreatment (Week 10) and a 3-month post-treatment follow-up assessment).
measure: Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
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.
Secondary outcomes:
measure: Depressive Symptoms as Assessed by the Beck Depression Inventory-II
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.
measure: Substance Use Assessed by the NIDA-Modified ASSIST
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.
measure: Quality of Life Assessed by the Quality of Life Inventory (QOLI)
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.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University, Stratton Hall
state: Pennsylvania
Study officials:
References:
citation: 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.