NCT07641205尚未招募不适用
Cognitive and Neural Mechanisms of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder Part II: Mediation Effects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Jennifer Thomas
Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Professor of Psychiatry
Massachusetts General Hospital
研究点 (1)
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