Evaluation of a 12-Week Web-Based Intervention for Bulimia Nervosa: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Changes in the frequency of binge eating episodes and compensatory behavior within the last 28 days
研究概览
简要总结
This study evaluates the effectiveness of a web-based intervention specifically designed for patients with Bulimia Nervosa (BN) in a blinded randomized controlled trial.
After a sign-up process, a diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BN or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions and six modular specialization areas resulting in a treatment period of 12 weeks. Minimal guidance is provided via a chat function.
Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment).
The investigators expect that the intervention group will show lower frequencies of binge eating episodes and compensatory behavior as the primary outcome variables after the 12 weeks of treatment compared to a waitlist control condition. Moreoever, the investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group.
Finally, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate emotions after the 12 weeks of treatment.
详细描述
Background: Bulimia Nervosa (BN) is characterized by persistent episodes of uncontrolled eating and inappropriate compensatory behaviors, associated with marked impairments in physical and mental health, social integration, professional performance, and overall quality of life. Although cognitive-behavioral therapies are effective for bulimia nervosa, access to specialized treatment in Germany is limited due to patient-related barriers and insufficient healthcare resources. Internet-based interventions can overcome this treatment gap and reduce the burden of BN for both patients and the healthcare system by making evidence-based interventions more accessible.
Goal: This study evaluates the effectiveness of a web-based intervention specifically designed for patients with BN in a blinded randomized controlled trial.
Method: After a sign-up process, a structured diagnostic interview, and a baseline assessment, eligible participants will be randomly allocated either to (1) an intervention group including the online web-based intervention for BN or (2) a waitlist control group with delayed access to the intervention (12 weeks). The program comprises six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. Moreover, minimal guidance is included, consisting of technical support and answering questions via a chat function. Assessments will be conducted at pretreatment (study entrance), six weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment). The primary outcome will be the number of binge eating episodes and compensatory behaviors. Secondary measures include global eating pathology, comorbid psychopathology, quality of life, self-esteem, emotion regulation, work capacity, and functional impairments.
Statistical Analyses: An intention-to-treat analysis will be performed to examine differences between the intervention and the control group in the change of eating disorder symptoms and secondary outcomes from pre- to post-treatment.
Hypotheses: The investigators expect that the intervention group will show lower frequencies of binge eating episodes and compensatory behavior as the primary outcome variables after the 12 weeks of treatment compared to a waitlist control condition. The investigators assume that there will be a higher reduction in global eating disorder symptoms, comorbid psychopathology, and a higher increase in well-being and self-esteem over 12 weeks in the intervention group compared to the waitlist control group. Moreover, the investigators expect that the intervention group will demonstrate a significantly higher reduction in functional impairment, substantially better restoration of work capacity, and an improved ability to regulate negative emotions after the 12 weeks 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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded about the two conditions of the study and told that the assigned waiting time for the web-based intervention varies randomly. Therefore, participants in the control group do not know that the other group starts the intervention immediately. However, complete masking of participants is precluded as all subjects are aware of when they get access to the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in the frequency of binge eating episodes and compensatory behavior within the last 28 days
时间窗: 0 weeks, 6 weeks, 12 weeks
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) captures the frequency of binge eating episodes and compensatory behavior within the last 28 days using 6 items. Higher values indicate a higher frequency of relevant eating disorder episodes.
次要结局
- Changes in global eating psychopathology(0 weeks, 6 weeks, 12 weeks)
- Changes in eating-disorder-related daily difficulties(0 weeks, 6 weeks, 12 weeks)
- Changes in self-esteem(0 weeks, 6 weeks, 12 weeks)
- Changes in well-being(0 weeks, 6 weeks, 12 weeks)
- Changes in the weekly frequency of binge eating episodes, compensatory behavior, and regular eating(0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks)
- Changes in comorbid depressive symptoms(0 weeks, 6 weeks, 12 weeks)
- Changes in everyday eating disorder symptoms(0 weeks, 12 weeks)
- Changes in comorbid anxiety symptoms(0 weeks, 6 weeks, 12 weeks)
- Changes in emotion regulation frequencies(0 weeks, 6 weeks, 12 weeks)
- Changes in emotion regulation difficulties(0 weeks, 6 weeks, 12 weeks)
- Changes in work capacity(0 weeks, 6 weeks, 12 weeks)
- Changes in everyday emotion regulation(0 weeks, 12 weeks)
研究者
Christina Timm
Principal Investigator
Heidelberg University