Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Eating Disorder Examination (EDE)
研究概览
简要总结
Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.
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
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
- •No major weight loss (defined as a reduction of 10% baseline body weight or more)
- •Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
- •Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
- •Subject must be living at home
- •At least one parent/guardian is willing to participate in the treatment.
排除标准
- •Subject on medications that influence weight or appetite (including antipsychotic medications)
- •Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
- •Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
- •Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.
结局指标
主要结局
Change in Eating Disorder Examination (EDE)
时间窗: baseline, end of treatment (approximately 8 months)
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales and a global score. The four subscales are: 1) Restraint, 2) Eating concern, 3) Shape concern, 4) Weight concern. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period, but some questions extend out to cover the previous 3 months. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall score, the four subscales scores are summed and the resulting total divided by the number of subscales (4). The total score can range from 0 (normal) to 6 (high eating disorder).
次要结局
未报告次要终点