Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability
研究概览
简要总结
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.
详细描述
A total of 57 individuals with ARFID ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (MBIE). MBIE targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. MBIE will be administered in 20 sessions. Interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. Follow-up assessments will be completed at session 5, 10, 15, and 20. The final assessment will take place 3 months after treatment ends. Total participation will last 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-18
- •Speaks English
- •Permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the American Psychiatric Association guidelines
- •Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5
- •Has a child aged 12-18 with a diagnosis of ARFID
- •Speaks English
排除标准
- •Comorbid psychotic or bipolar disorder
- •Psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing
- •Active suicidal ideation
- •Major medical condition (e.g., diabetes mellitus, pregnancy)
- •Current substance dependence, as evidenced by tolerance and withdrawal
- •Evidence of anatomical findings by imaging (e.g., swallow study) that would prevent safe consumption of the shake or those with a percutaneous endoscopic gastrostomy or other similar feeding tube insertion
- •Children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures).
研究组 & 干预措施
Mindfulness-based interoceptive exposure (MBIE)
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
干预措施: MBIE (Behavioral)
结局指标
主要结局
MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability
时间窗: up to 6 months
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability
时间窗: up to 6 months
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
次要结局
- Number of MBIE sessions required to achieve tolerability(up to 6 months)
- Therapist Adherence to MBIE Therapy(up to 6 months)
- Dropout Rate(end of treatment, at approximately 6 months)
- Participant Rating of Acceptability Scale(up to 9 months)
- Change in Expected Body Weight Percentage(Baseline and approximately 6 months)
- Functional Food Hierarchy to Measure Tolerability(up to 6 months)
- Change in total calories consumed(Baseline and approximately 6 months)
- Therapist Adherence to MBIE Therapy(Session 20, at week 20)
- Number of Participants Who Withdrew(Session 20, at week 20)
- Participant Rating of Acceptability Scale(baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20))
- Number of MBIE Sessions Required to Achieve Tolerability(up to 6 months)
- Change in Total Calories Consumed(Baseline and approximately 10 weeks and 20 weeks)
- Change in Body Mass Index (BMI) Percentile(Baseline and session 20 (at week 20))
- Change in total calories consumed(Baseline and approximately 10 weeks)
研究者
Robyn Sysko
Associate Professor
Icahn School of Medicine at Mount Sinai