A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Impairment
研究概览
简要总结
This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.
详细描述
A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.
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
- 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
- •Speak English
- •Permission from pediatrician or equivalent to receive outpatient care
- •Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
- •Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories
排除标准
- •Comorbid psychotic or bipolar disorder
- •Active suicidal ideation
- •Current substance dependence
- •Psychiatric medication initiated or dosage changes <2 weeks from baseline
- •Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
研究组 & 干预措施
Interoceptive Exposure Treatment (IE)
Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.
干预措施: Interoceptive Exposure Treatment (IE) (Behavioral)
Family-Based Treatment (FBT)
Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.
干预措施: Family-Based Treatment (FBT) (Behavioral)
结局指标
主要结局
Change in Impairment
时间窗: Baseline and 18-months
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 1 year after treatment (18-months) scores from CIA.
Change in Expected Body Weight Percentage
时间窗: Baseline and 18-months
Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.
次要结局
- Change in Autonomous Eating(Baseline and 18-months)
- Change in Nonjudgmental Body Awareness(Baseline and 18-months)
- Change in Food Cue Learning(Baseline and 18-months)
- Change in Eating Disorder Symptoms(Baseline and 18-months)
研究者
Tom Hildebrandt
Professor
Icahn School of Medicine at Mount Sinai