Evaluation of a Web-Based Intervention for Bulimia Nervosa
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Selfapy for Bulimia Nervosa
Intervention type(s): Other
Intervention description(s): Web-based intervention for Bulimia Nervosa with 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. During the intervention, participants can access an online chat providing crisis management, answering questions concerning the exercises, and technical support. The chat does not include the opportunity to discuss individual topics and concerns about treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with an intervention group and a waiting list control group
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ecological Momentary Assessment; Internet-based Intervention; Randomized Controlled Trial