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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
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.
Heidelberg University
Heidelberg, Baden-Wurttemberg, Germany
Changes in the frequency of binge eating episodes and compensatory behavior within the last 28 days
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.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in global eating psychopathology
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) allows assessing global eating psychopathology based on 22 items. Mean scores range from 0 to 6, with higher values indicating a higher global eating psychopathology.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in the weekly frequency of binge eating episodes, compensatory behavior, and regular eating
The Weekly Binges Questionnaire (WBQ; Munsch et al., 2007) assesses the frequency of binge eating episodes, compensatory behavior, and regular eating by asking participants to count the number of binge eating episodes, the number of compensatory behaviors, and the number of days with regular eating habits. While a higher number of binges and compensatory behaviors indicates a higher symptomatology, a higher number of regular eating days indicates a lower symptomatology.
Time frame: 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
Ecological momentary assessment (EMA) of eating disorder symptoms (shape concerns, weight concerns, binge eating episodes, episodes of compensatory behaviors, urges to eat or compensate) for five days (five signal-contingent measurements and additional event-contingent assessments)
Time frame: 0 weeks, 12 weeks
Changes in eating-disorder-related daily difficulties
The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008) consists of 16 items answered on a 4-point Likert scale. The overall score ranges from 0 to 48. Higher values indicate a higher level of clinical impairment.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid depressive symptoms
The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) consists of 9 items answered on a 4-point scale. The overall score ranges from 0 to 27. Higher values indicate a higher level of depressive symptomology.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in comorbid anxiety symptoms
The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) consists of 7 items answered on a 4-point scale. The overall score ranges from 0 to 21. Higher values indicate a higher level of anxiety symptoms.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in well-being
The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015) consists of 5 items answered on a 6-point scale. The overall score ranges from 0 to 100. Higher values indicate a higher level of well-being.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in self-esteem
The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008) consists of 10 items answered on a 4-point scale. The overall score ranges from 0 to 30. Higher values indicate a higher level of self-esteem.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in work capacity
The iMTA Productivity Cost Questionnaire (iPCQ; Bouwmans et al., 2015) consists of 12 items grouped in general questions about paid work and questions about productivity losses in paid and unpaid work. The questionnaire captures the missed work time (paid and unpaid) in hours for short-term absence and calendar days for long-time absence and the hours of lost productivity due to presenteeism.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation frequencies
The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019) consists of 28 items answered on a 5-point scale. For each of the eight emotion regulation strategies (rumination, reappraisal, acceptance, problem solving, suppression of emotional expression, suppression of emotional experience, avoidance, social support), a score ranging from 1 to 5 can be calculated. Higher values indicate a higher frequency of emotion regulation strategy endorsement.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation difficulties
The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) consists of 36 items answered on a 5-point scale. The overall score ranges from 36 to 180. Higher values indicate a higher level of emotion regulation difficulties.
Time frame: 0 weeks, 6 weeks, 12 weeks
Changes in everyday emotion regulation
Ecological momentary assessment (EMA) of affect, emotion regulation strategies and difficulties for five days (five signal-contingent measurements, and additional event-contingent assessments)
Time frame: 0 weeks, 12 weeks
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