Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Eating Disorder Examination (EDE)
研究概览
简要总结
The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.
详细描述
This study involves a brief phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 12 sessions of CBT treatment and will be randomly assigned to an ICT or ICT sham condition which will consist of completing ICT computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. Participants will also complete research assessments at mid-treatment, post-treatment, and 3-month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and behavioral tasks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators, therapists, and graduate student assessors will be blinded to treatment condition. The only staff member who cannot be blinded to condition is the study coordinator; she will be aware of condition because of managing randomization and assisting participants in the downloading of the intervention to participants' computers.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-55
- •meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
- •be stable on psychiatric medications for at least 3 months
排除标准
- •have a diagnosis of anorexia nervosa or a BMI < 18.5
- •have extreme malnutrition or other medical complications that require acute hospitalization
- •are at acute suicide risk
- •are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
- •have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating Disorder
- •have a diagnosis of an intellectual disability or autism spectrum disorder
- •currently taking stimulant medications
- •score of 95% or higher on 550ms block of Go/No-Go assessment task, indicating high inhibitory control at Baseline
结局指标
主要结局
Eating Disorder Examination (EDE)
时间窗: Change in binge frequency from baseline to post-treatment and 3-month follow-up
The Eating Disorder Examination is a widely utilized, semi-structured interview for the assessment of eating disorder symptoms and the binge-eating module will be used to determine binge episode frequency.
次要结局
- Food Frequency Questionnaire (FFQ)(Change from baseline to post-treatment and 3-month follow up)