Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic

NCT04661410 | Completed Results DMC

• 2 other identifiers: 2009008088R01MH122392-01S1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (4)

• 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.

Secondary Outcomes (3)

• Depressive Symptoms as Assessed by the Beck Depression Inventory-II

  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

  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)

  Each assessment time point throughout treatment (Pretreatment (Baseline), Mid-treatment (Week 5), Posttreatment (Week 10)) and a 3-month post-treatment follow-up assessment.

Study Arms (2)

Reward Re-Training

EXPERIMENTAL

10 weekly sessions of Reward Re-Training Group Therapy.

Behavioral: Reward Re-Training

Supportive Therapy

ACTIVE COMPARATOR

10 weekly sessions of Supportive Group Therapy.

Behavioral: Supportive Therapy

Interventions

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.

Reward Re-Training

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.

Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 39101915 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.

  PMID: 33908655 DERIVED

Related Links

• For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu.

MeSH Terms

Conditions

Bulimia Nervosa; Bulimia; Binge-Eating Disorder; Feeding and Eating Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Adrienne Juarascio
• Organization: The WELL Center

asj32@drexel.edu

443-801-8093

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 10, 2020
• Study Start: December 1, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Locations

US (1)