Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change in eating disorder psychopathology
研究概览
简要总结
The goal of this randomized controlled clinical trial is to compare the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders.
Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design.
The main aim is to determine if enhanced cognitive behavior therapy has a similar efficacy as family-based treatment among children and adolescents with eating disorders receiving treatment in an outpatient setting. The main outcome is improvement in eating disorders psychopathology at the end of treatment.
详细描述
Eating disorders (EDs) are severe mental illnesses, associated with high morbidity, increased mortality, and reduced quality of life. Despite treatment advancements, remission rates are modest. Even in specialized treatment settings offering evidence-based treatments such as family-based treatment (FBT), remission rates are about 50%. There is emerging evidence for the effectiveness of enhanced cognitive behavior therapy (CBT-E) for adolescents with EDs. However, no randomized controlled trial (RCT) has yet compared these two treatments.
The current study will compare FBT, which has proven efficacious and is currently recommended for adolescents with EDs, and the newer treatment approach of CBT-E in a large, national RCT. Young patients with all EDs (12-18 years of age) undergoing outpatient treatment from eight different clinics in Norway will be invited to participate in the study.
Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design.
Primary aim:
This study is a randomized controlled trial comparing the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders. The main outcome is improvement in eating disorders psychopathology at the end of treatment.
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
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed eating disorder
- •Medically stable for outpatient treatment.
- •Living with at least one of their parents
- •At least one of their parents could be actively involved in the treatment
- •Sufficient knowledge in reading, understanding and speaking Norwegian
排除标准
- •Avoidant restrictive food intake disorders
- •A co-morbid medical condition or disorder known to influence eating or weight, or influence the possibilities to take part in treatment
- •Psychotic disorders
- •Acute suicidality
- •Substance abuse and/or substance dependence
- •Serious traumatic events in the family making treatment following FBT or CBT-E manual not recommended
- •Unstable psychotropic medication last 6 weeks
研究组 & 干预措施
Family-based treatment for adolescents with an eating disorder (FBT)
FBT for adolescent eating disorders usually includes all members of the adolescent's immediate family. Treatment progresses through three phases, with the first (∼10 sessions) focusing mainly on guiding the parents to support their adolescent toward weight restoration (when appropriate), and disrupting eating disorder behaviors (e.g. binge eating and purging). The second phase (∼5-7 sessions) focuses on assisting the parents to restore food choices to the adolescent, with an emphasis on the developmental stage of the adolescent. Phase 3 is brief (2-3 sessions), focusing on adolescent developmental matters and helping the parents and their offspring navigate these tasks largely in the absence of acute eating disorder symptoms. Twenty treatment sessions are provided over a span of approximately 6 months.
干预措施: Family-based therapy for adolescents with an eating disorder (Behavioral)
Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E)
CBT-E posits the eating problem as belonging to the individual, and is designed to encourage the adolescent, rather than their parent, to take control of the problem. Parents are not excluded from participating in treatment, but their involvement is limited to helping to create a family environment that allows for recovery. Patients are actively involved in all phases of treatment, including the decision to address weight regain and/or binge eating and purging, with the goal of promoting self-management. A primary goal of CBT-E is to address the patient's eating disorder psychopathology, i.e. patients' concerns about shape, weight, dietary restraint and restriction, and other extreme weight control behaviors. Following manualized CBT-E guidelines, for patients in the lower weight cohort, treatment involves 40 sessions over 9-12 months. For those in the higher weight cohort, treatment involves 20 sessions over the course of 6 months.
干预措施: Enhanced Cognitive-behavior therapy for adolescents with an eating disorder (Behavioral)
结局指标
主要结局
Change in eating disorder psychopathology
时间窗: Baseline, immediately after the intervention.
Change in global scores on a well-validated semi-structured interview of eating disorder attitudes and behavior, the Eating Disorder Examination - Interview. Possible scores range from 0-6 where higher scores indicate worse symptoms.
次要结局
- Change in quality of life(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- Change in eating disorder psychopathology(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment.)
- Change in self-esteem(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- Change in weight (kg) for underweight participants (defined as those participants who are below 18,5 Body Mass Index (BMI) (kg/m2) at baseline or corresponding BMI to age and gender).(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- Change in depression(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- Change in impairment due to eating difficulties(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- Change in anxiety(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
研究者
Øyvind Rø MD
Research director
Oslo University Hospital