Clinical trial NCT04876196: Evaluation of a Web-Based Intervention for Bulimia Nervosa
Official title: Evaluation of a 12-Week Web-Based Intervention for Bulimia Nervosa: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
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: 152
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 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* 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)

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 and compensatory behavior 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, compensatory behavior, 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
References:
citation: Berg KC, Peterson CB, Frazier P, Crow SJ. Psychometric evaluation of the eating disorder examination and eating disorder examination-questionnaire: a systematic review of the literature. Int J Eat Disord. 2012 Apr;45(3):428-38. doi: 10.1002/eat.20931. Epub 2011 Jul 8.
citation: 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.
citation: 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.
citation: Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.