Evaluation of a Web-Based Intervention for Binge Eating Disorder

November 29, 2023 updated by: Christina Timm, Heidelberg University

Evaluation of a 12-Week Web-Based Intervention for Binge Eating Disorder: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69117
        • Heidelberg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist Control Group
12-week waiting period
Active Comparator: Intervention Group
Web-based intervention (Selfapy for Binge Eating Disorder)
Other: Selfapy for Binge Eating Disorder
Web-based intervention for Binge Eating Disorder 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 weeks, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in global eating psychopathology
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in eating-disorder-related daily difficulties
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in comorbid depressive symptoms
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in comorbid anxiety symptoms
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in well-being
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in self-esteem
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in work capacity
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation frequencies
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in emotion regulation difficulties
Time Frame: 0 weeks, 6 weeks, 12 weeks
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.
0 weeks, 6 weeks, 12 weeks
Changes in everyday emotion regulation
Time Frame: 0 weeks, 12 weeks
Ecological momentary assessment (EMA) of affect, emotion regulation strategies and difficulties for five days (five signal-contingent measurements, and additional event-contingent assessments)
0 weeks, 12 weeks
Changes in the weekly frequency of binge eating episodes and regular eating
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
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.
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
Time Frame: 0 weeks, 12 weeks
Ecological momentary assessment (EMA) of eating disorder symptoms (shape concerns, weight concerns, binge eating episodes, urges to eat) for five days (five signal-contingent measurements and additional event-contingent assessments)
0 weeks, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in attitudes towards psychological online interventions
Time Frame: 0 weeks, 12 weeks
Two subscales of the Attitudes Towards Psychological Online Interventions Scale (APOI; Schroeder et al., 2015) will be used. These capture technologization threat and perceived anonymity benefits using 8 items on a 5-point scale. Higher values indicate a more positive attitude towards psychological online interventions.
0 weeks, 12 weeks
Changes in patient outcome expectancies
Time Frame: 0 weeks, 6 weeks (intervention group), 12 weeks
The Patients' Therapy Expectation and Evaluation Scale (PATHEV; Schulte, 2008) consists of 16 items answered on a 5-point scale. The overall score ranges from 0 to 5. Higher values indicate more positive expectancies towards the therapy.
0 weeks, 6 weeks (intervention group), 12 weeks
Negative intervention effects
Time Frame: 6 weeks (intervention group), 12 weeks
The Negative Effects Questionnaire (NEQ; Rozental et al., 2019) consists of 32 items. For each item, the participants answer whether the adverse effect occurred (yes/no), how strong the negative effect was (0 to 4) and whether they attribute the negative effect on the treatment or something else. Two scores can be obtained, one for the frequency of adverse effects due to treatment, ranging from 0 to 32, and one for the negative impact, ranging from 0 to 128. Higher values indicate a higher level of adverse effects.
6 weeks (intervention group), 12 weeks
Use of other healthcare services
Time Frame: 0 weeks, 6 weeks, 12 weeks
The Client Sociodemographic Service Receipt Inventory - European Version (CSSRI-EU; Chisholm et al., 2000) allows assessing the number and length of using different types of healthcare services. Higher values indicate a higher number and frequency of healthcare service usage.
0 weeks, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Selfapy GmbH

Investigators

  • Principal Investigator: Luise Pruessner, Department of Psychology, Heidelberg University
  • Principal Investigator: Christina Timm, PhD, Department of Psychology, Heidelberg University
  • Principal Investigator: Steffen Hartmann, Department of Psychology, Heidelberg University
  • Principal Investigator: Sven Barnow, Prof., Department of Psychology, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

August 3, 2022

Study Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Selfapy-BED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be uploaded after publication of the results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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