Clinical trial NCT04876183: Evaluation of a Web-Based Intervention for Binge Eating Disorder
Official title: Evaluation of a 12-Week Web-Based Intervention for Binge Eating Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: Ecological Momentary Assessment
Internet-based Intervention
Randomized Controlled Trial
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Selfapy GmbH
First posted: 2021-05-06
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with an intervention group and a waiting list control group
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* sufficient German language skills (C1)
* permanent internet access during the study period
* meeting the diagnostic criteria for Binge Eating Disorder according to the Diagnostic- and Statistical Manual of Mental Disorders (DSM-5)

Exclusion criteria:

* current severe depressive episode
* acute suicidality
* comorbid bipolar disorder or psychotic disorders
* acute substance dependence
* current psychotherapy or pharmacotherapy for eating disorders
* Body Mass Index (BMI) below 18.5

Primary outcomes:
measure: Changes in the frequency of binge eating episodes within the last 28 days
timeFrame: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Changes in global eating psychopathology
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in the weekly frequency of binge eating episodes and regular eating
timeFrame: 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
measure: Changes in everyday eating disorder symptoms
timeFrame: 0 weeks, 12 weeks
measure: Changes in eating-disorder-related daily difficulties
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in comorbid depressive symptoms
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in comorbid anxiety symptoms
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in well-being
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in self-esteem
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in work capacity
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in emotion regulation frequencies
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in emotion regulation difficulties
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Changes in everyday emotion regulation
timeFrame: 0 weeks, 12 weeks
Other outcomes:
measure: Changes in attitudes towards psychological online interventions
timeFrame: 0 weeks, 12 weeks
measure: Changes in patient outcome expectancies
timeFrame: 0 weeks, 6 weeks (intervention group), 12 weeks
measure: Negative intervention effects
timeFrame: 6 weeks (intervention group), 12 weeks
measure: Use of other healthcare services
timeFrame: 0 weeks, 6 weeks, 12 weeks
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
state: Baden-Württemberg
Study officials:
affiliation: Department of Psychology, Heidelberg University
name: Luise Pruessner
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Christina Timm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Steffen Hartmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Sven Barnow, Prof.
role: PRINCIPAL_INVESTIGATOR
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