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临床试验/NCT04242550
NCT04242550已完成不适用

Executive Function Training for Binge Eating Disorder and Comorbid Mood/Anxiety Disorders

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Feasibility as measured by number of treatment sessions attended

研究概览

简要总结

Binge Eating Disorder (BED) is the most common eating disorder, and currently, the best behavioral treatments only work for 40-60% of adults. BED often co-occurs with mood and anxiety disorders, and both are associated with neurocognitive deficits related to executive function (EF). These EF deficits contribute to worsening BED symptoms and make it difficult for these adults to adhere to treatment recommendations. The proposed study aims to develop an EF training enhanced behavioral treatment for BED and compare its effectiveness to the standard cognitive behavioral therapy for patients with BED and a co-occurring mood or anxiety disorder.

详细描述

A randomized controlled trial (RCT) will evaluate an EF training enhanced cognitive behavioral therapy (CBT) for BED (EF-BED+CBT) compared to standard CBT in patients with BED and a comorbid mood/anxiety disorder to assess the feasibility, acceptability, and preliminary efficacy of EF-BED+CBT in reducing binge eating, impairment, and comorbid depression/anxiety symptoms. Adult participants with BED and comorbid mood/anxiety disorder will be randomized to a four month remote treatment of either EF-BED+CBT or CBT alone. Participants will be assessed at baseline, following treatment (month 4) and 2-month follow-up (month 6).

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 (Outcomes Assessor)

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

入选标准

  • Age 18-65
  • Ability to read English at a 6th grade level
  • Clinical or subclinical BED and at least one comorbid mood or anxiety disorder

排除标准

  • Known cognitive disability (e.g., brain injury with loss of consciousness >30 min, intellectual disability)
  • Psychosis
  • Psychiatric condition that could interfere with program participation (e.g., substance abuse, suicide attempt within previous 6 months, active purging, active suicidality)
  • Currently pregnant, lactating or plan to be in the timespan of program follow-up
  • Change in psychotropic medication or other medication that could have impact on weight, binge eating or anxiety/mood symptoms during the previous 3 months
  • Participating in an organized program for overeating

结局指标

主要结局

Feasibility as measured by number of treatment sessions attended

时间窗: Over the course of 4 months of treatment

Attendance at Treatment Sessions

Acceptability

时间窗: At 4 months

Ratings of usefulness of treatment measured by responses to Likert-type ratings developed by the study team.

次要结局

  • Binge Eating(Through study completion, an average of 6 months)
  • Impairment(Through study completion, an average of 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Eichen

Assistant Adjunct Professor

University of California, San Diego

研究点 (2)

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