Evaluation of a 12-Week Web-Based Intervention for Binge Eating Disorder: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Binge Eating Disorder
- Sponsor
- Heidelberg University
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Changes in the frequency of binge eating episodes within the last 28 days
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study evaluates the effectiveness of a web-based intervention specifically designed for patients with Binge Eating Disorder (BED) 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 BED 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 as the primary outcome variable after the 12 weeks of treatment compared to a waitlist control condition. Moreover, 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.
Detailed Description
Background: Binge Eating Disorder (BED) is characterized by persistent episodes of uncontrolled eating, 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 Binge Eating Disorder, 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 BED 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 BED 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 BED 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. 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 as the primary outcome variable 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.
Investigators
Christina Timm
Principal Investigator
Heidelberg University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes in the frequency of binge eating episodes within the last 28 days
Time Frame: 0 weeks, 6 weeks, 12 weeks
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) captures the frequency of binge eating episodes within the last 28 days using 3 items. Higher values indicate a higher frequency of binge eating episodes.
Secondary Outcomes
- Changes in global eating psychopathology(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)
- Changes in comorbid depressive symptoms(0 weeks, 6 weeks, 12 weeks)
- Changes in emotion regulation frequencies(0 weeks, 6 weeks, 12 weeks)
- Changes in the weekly frequency of binge eating episodes 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 everyday eating disorder symptoms(0 weeks, 12 weeks)
- Changes in eating-disorder-related daily difficulties(0 weeks, 6 weeks, 12 weeks)
- Changes in comorbid anxiety symptoms(0 weeks, 6 weeks, 12 weeks)
- Changes in well-being(0 weeks, 6 weeks, 12 weeks)
- Changes in self-esteem(0 weeks, 6 weeks, 12 weeks)
- Changes in emotion regulation difficulties(0 weeks, 6 weeks, 12 weeks)