Evaluation of a Web-Based Intervention for Binge Eating Disorder

Sponsor

Heidelberg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04876183

Collaborator

Selfapy GmbH (Other)

150

Enrollment

Location

Arms

20.6

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder	Other: Selfapy for Binge Eating Disorder	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial with an intervention group and a waiting list control groupRandomized controlled trial with an intervention group and a waiting list control group

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participants are blinded about the two conditions of the study and told that the assigned waiting time for the web-based intervention varies randomly. Therefore, participants in the control group do not know that the other group starts the intervention immediately. However, complete masking of participants is precluded as all subjects are aware of when they get access to the intervention.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 12, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Waitlist Control Group 12-week waiting period

Arm

Intervention/Treatment

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.

No Intervention: Waitlist Control Group

12-week waiting period

Outcome Measures

Primary Outcome Measures

Changes in the frequency of binge eating episodes within the last 28 days [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 Outcome Measures

Changes in global eating psychopathology [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.
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]
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.
Changes in everyday eating disorder symptoms [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)
Changes in eating-disorder-related daily difficulties [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.
Changes in comorbid depressive symptoms [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.
Changes in comorbid anxiety symptoms [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.
Changes in well-being [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.
Changes in self-esteem [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.
Changes in work capacity [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.
Changes in emotion regulation frequencies [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.
Changes in emotion regulation difficulties [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.
Changes in everyday emotion regulation [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)

Other Outcome Measures

Changes in attitudes towards psychological online interventions [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.
Changes in patient outcome expectancies [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.
Negative intervention effects [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.
Use of other healthcare services [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heidelberg University	Heidelberg	Baden-Württemberg	Germany	69117

Sponsors and Collaborators

Heidelberg University
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