Development and Initial Efficacy Testing of a Cognitive-Behavioral Intervention to Treat Adolescent Binge Eating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Binge (Loss-of-control) Eating Episode Frequency
研究概览
简要总结
This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.
详细描述
Youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. As there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. Among adults, cognitive-behavioral therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. This study will develop a new CBT treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). This study will also test the efficacy of the newly-developed CBT for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included, adolescents must:
- •Be in the age range ≥12 years old and ≤17 years old;
- •Have a BMI that places them above the 85th percentile based on their age and sex;
- •Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
- •Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
- •Read, comprehend, and write English at a sufficient level to complete study-related materials;
- •Be available for participation in the study for 7 months.
排除标准
- •Prospective participants will be excluded if the adolescent:
- •Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
- •Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
- •Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
- •Is pregnant or breastfeeding;
- •Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
- •Began taking hormonal contraceptives less than 3 months prior;
- •Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
- •Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
- •Is participating in another clinical research study.
研究组 & 干预措施
Cognitive-Behavioral Therapy
Adapted Cognitive-Behavioral Therapy (CBT) for adolescents with binge eating or loss-of-control eating.
干预措施: Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating (Behavioral)
Control Condition
Educational materials related to adolescent health and nutrition.
干预措施: Control Condition (Other)
结局指标
主要结局
Binge (Loss-of-control) Eating Episode Frequency
时间窗: Post (4 months)
Eating episodes will be assessed by questionnaire (Eating Disorder Examination questionnaire)
Weight (e.g., Percent Loss)
时间窗: Post (4 months)
Percent BMI change
次要结局
- Binge (Loss-of-control) Eating Episode Frequency(Short-Term Follow-Up (3 months after end of treatment))
- Weight (e.g., Percent Loss)(Short-Term Follow-Up (3 months after end of treatment))