此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II (COUNTERACT-2)

2026年6月12日 更新者：Jennifer Thomas、Massachusetts General Hospital

Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects

This study is a randomized controlled trial assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Eating Disorders Clinical and Research Program
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Males and Females ages 10-18 years old
  • Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
  • Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
  • Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
  • Fluency and literacy in English

Exclusion Criteria:

  • Patient requires weight restoration treatment (e.g., < 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
  • Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
  • Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
  • Substance/alcohol use disorder (active within the past month) via MINI KID
  • Medical instability requiring inpatient care according to the American Psychiatric Association 2006 treatment guidelines for eating disorders
  • Laboratory abnormalities indicating a need for higher level of care (assessed by complete blood count and comprehensive metabolic panel) exclusionary for randomization
  • Complete lack of oral intake (suggesting a need for inpatient care)
  • Tube feeding (suggesting a need for tube weaning) Significant weight/shape concern-motivating eating pathology as evidenced by a global Eating Disorders Examination Questionnaire (EDE-Q) score greater than 4
  • Active suicidal ideation with intent or plan via the 5-item Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
  • Contraindications to MRI
  • History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
  • Medical history of intellectual disability
  • Illiteracy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：CBT-AR
参见干预措施描述
行为的：Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual.
实验性的：营养咨询
参见干预措施描述
行为的：回避/限制性食物摄入障碍的营养咨询
营养咨询将由 MGH 转化和临床研究中心 (TCRC) 的熟练注册营养师提供。 会议重点讨论健康饮食所需的食物、如何满足营养需求、如何结合健康锻炼以及对做出这些改变的支持。 对于 10-15 岁的参与者，患者/监护人参加会议。 对于 16 岁及以上的患者，治疗是个体化的。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pica, ARFID, and Rumination Disorder Interview
大体时间：Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity.
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
Pica, ARFID, and Rumination Disorder ARFID Questionnaire
大体时间：Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.
A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity.
Change from baseline measured at Pre-Treatment to Mid-Treatment to 15 weeks of treatment measured at Post-Treatment.

次要结果测量

结果测量
措施说明
大体时间
General Nutrition Knowledge Questionnaire
大体时间：Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
A revised version of the General Nutrition Knowledge Questionnaire (GNKQ) used to evaluate knowledge of nutrition. Scores are gathered through a series of multiple-choice questions. The lowest score possible is 0, indicating low knowledge of nutrition, and the highest score possible is 14, indicating high knowledge of nutrition.
Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
4-Day Food Record
大体时间：Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)
A record of participant diet for four days prior to the Pre-Treatment Assessment and for another four days prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods.
Completed at Pre-Treatment Assessment (Baseline/Week 0), Mid-Treatment Assessment (Week 8 +/- 2 sessions), and Post-Treatment Assessment (Week 16 up to Week 19)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年10月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • P202600305

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The investigators will upload de-identified data to the NIMH National Data Archive at the conclusion of the study

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅