Cognitive and Neural Mechanisms of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging (fMRI) food cue paradigm
研究概览
简要总结
This study is a randomized controlledlinical 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
- •Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms
- •Negative celiac screening panel indicating no active celiac disease as cause of symptoms
- •Fluency and literacy in English
排除标准
- •BMI < 5th percentile for sex and age
- •Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit
- •Current/history of psychosis
- •Substance/alcohol use disorder (active within the past month)
- •Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders
- •Laboratory abnormalities indicating a need for higher level of care
- •Complete lack of oral intake (suggesting a need for inpatient care)
- •Tube feeding (suggesting a need for tube weaning)
- •Active suicidal/homicidal ideation with intent or plan
- •Contraindications to MRI
- •History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer)
- •Medical history of intellectual disability
- •Illiteracy
研究组 & 干预措施
CBT-AR
See intervention description
干预措施: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) (Behavioral)
Nutrition Counseling
See intervention description
干预措施: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder (Behavioral)
结局指标
主要结局
Functional magnetic resonance imaging (fMRI) food cue paradigm
时间窗: Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment
Used to measure neural activation in response to food cues. Higher scores indicate higher neural activation. There is no minimum or maximum for this measure.
Food Neophobia Scale
时间窗: Change from baseline food neophobia measured at pre-treatment to after each weekly session of treatment and after the complete 15 weeks of treatment measured at post-treatment
Validated 6-item version of the Food Neophobia Scale used to assess food neophobia on a scale from 1 to 7, with higher scores indicating higher levels of food neophobia. The lowest score possible is 7, indicating low food neophobia, and highest score possible is 42, indicating high food neophobia.
次要结局
- General Nutrition Knowledge Questionnaire (GNKQ)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder Interview (PARDI)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- General Nutrition Knowledge Questionnaire (GNKQ)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder Interview (PARDI)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q)(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
- 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups.(Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment)
研究者
Jennifer Thomas
Eating Disorder Clinical and Research Program (EDCRP) Co-Director/Associate Professor of Psychiatry
Massachusetts General Hospital