Evaluation of a Web-Based Intervention for Bulimia Nervosa

NCT04876196 | Completed

• 1 other identifier: Selfapy-BN
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bulimia Nervosa

Keywords

Ecological Momentary Assessment; Internet-based Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  0 weeks, 6 weeks, 12 weeks

Secondary Outcomes (12)

• Changes in global eating psychopathology

  0 weeks, 6 weeks, 12 weeks

• Changes in the weekly frequency of binge eating episodes, compensatory behavior, 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

• Changes in everyday eating disorder symptoms

  0 weeks, 12 weeks

• Changes in eating-disorder-related daily difficulties

  0 weeks, 6 weeks, 12 weeks

• Changes in comorbid depressive symptoms

  0 weeks, 6 weeks, 12 weeks

Other Outcomes (4)

• Changes in attitudes towards psychological online interventions

  0 weeks, 12 weeks

• Changes in patient outcome expectancies

  0 weeks, 6 weeks (intervention group), 12 weeks

• Negative intervention effects

  6 weeks (intervention group), 12 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Web-based intervention (Selfapy for Bulimia Nervosa)

Other: Selfapy for Bulimia Nervosa

Waitlist Control Group

NO INTERVENTION

12-week waiting period

Interventions

Selfapy for Bulimia Nervosa OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Selfapy GmbH: collaborator

Study Sites (1)

Heidelberg University

Heidelberg, Baden-Wurttemberg, 69117, Germany

Location

Related Publications (17)

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  PMID: 21744375 BACKGROUND

• Bohn K, Doll HA, Cooper Z, O'Connor M, Palmer RL, Fairburn CG. The measurement of impairment due to eating disorder psychopathology. Behav Res Ther. 2008 Oct;46(10):1105-10. doi: 10.1016/j.brat.2008.06.012. Epub 2008 Jul 2.

  PMID: 18710699 BACKGROUND

• Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, Hakkaart-van Roijen L. The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Value Health. 2015 Sep;18(6):753-8. doi: 10.1016/j.jval.2015.05.009. Epub 2015 Aug 20.

  PMID: 26409601 BACKGROUND

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  PMID: 10945075 BACKGROUND

• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.

  BACKGROUND

• Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.

  PMID: 28730850 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Munsch S, Biedert E, Meyer A, Michael T, Schlup B, Tuch A, Margraf J. A randomized comparison of cognitive behavioral therapy and behavioral weight loss treatment for overweight individuals with binge eating disorder. Int J Eat Disord. 2007 Mar;40(2):102-13. doi: 10.1002/eat.20350.

  PMID: 17089420 BACKGROUND

• Roth, M., Decker, O., Herzberg, P. Y., & Brähler, E. (2008). Dimensionality and norms of the Rosenberg Self-Esteem Scale in a German general population sample. European Journal of Psychological Assessment, 24(3), 190-197.

  BACKGROUND

• Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.

  PMID: 30871650 BACKGROUND

• Schroder J, Sautier L, Kriston L, Berger T, Meyer B, Spath C, Kother U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28.

  PMID: 26331687 BACKGROUND

• Schulte D. Patients' outcome expectancies and their impression of suitability as predictors of treatment outcome. Psychother Res. 2008 Jul;18(4):481-94. doi: 10.1080/10503300801932505.

  PMID: 18815999 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

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• Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

  PMID: 25831962 BACKGROUND

• Chih CP, He J, Sly TS, Roberts EL Jr. Comparison of glucose and lactate as substrates during NMDA-induced activation of hippocampal slices. Brain Res. 2001 Mar 2;893(1-2):143-54. doi: 10.1016/s0006-8993(00)03306-0.

  PMID: 11223002 BACKGROUND

• Hartmann S, Timm C, Barnow S, Rubel JA, Lalk C, Pruessner L. Web-Based Cognitive Behavioral Treatment for Bulimia Nervosa: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419019. doi: 10.1001/jamanetworkopen.2024.19019.

  PMID: 38958978 DERIVED

• Hartmann S, Pruessner L, Rubel JA, Lalk C, Barnow S, Timm C. Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial. Internet Interv. 2022 Feb 17;28:100512. doi: 10.1016/j.invent.2022.100512. eCollection 2022 Apr.

  PMID: 35251938 DERIVED

MeSH Terms

Conditions

Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial with an intervention group and a waiting list control group

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 6, 2021
• Study Start: January 12, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)