Reward Re-Training: A New Treatment to Address Reward Imbalance During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Binge Eating Frequency Assessed by the Eating Disorder Examination
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Reward Re-Training
10 weekly sessions of Reward Re-Training Group Therapy.
干预措施: Reward Re-Training (Behavioral)
Supportive Therapy
10 weekly sessions of Supportive Group Therapy.
干预措施: Supportive Therapy (Behavioral)
结局指标
主要结局
Binge Eating Frequency Assessed by the Eating Disorder Examination
时间窗: 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
时间窗: 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.
Compensatory Behavior Frequency Assessed by the Eating Disorder Examination (EDE)
时间窗: 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
Remission Status
时间窗: 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).
次要结局
- 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.)
- 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.)