Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Eating Disorder | Study protocol

Binge-eating disorder treatment goes online – feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group

Authors: Simone Munsch, Andrea Wyssen, Pierre Vanhulst, Denis Lalanne, Sharon T. Steinemann, Alexandre Tuch

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Binge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overweight and obesity. In community-based samples, 2–4% of women and 1–3% men are diagnosed with BED. Psychotherapeutic interventions focusing on maintenance factors of disturbed eating behavior have proven to be effective. However, treatment access is limited for a considerable number of patients with BED. A lack of specialized institutions and treatment resources, but also long distances to treatment facilities for people living in remote or rural areas are often causes of insufficient care. Internet-based guided self-help (GSH) programs have the potential to fill this gap.

Methods

This project aims to develop and evaluate an Internet-based treatment for BED derived from an evidence-based manualized cognitive behavioral therapy (CBT). The primary goal is to test feasibility and suitability of the Internet-based program and to evaluate the treatment outcome in comparison to a pure and a placebo-inspired waitlist control group (i.e. reduction of binge-eating episodes and eating disorder pathology as primary outcome variables). In total, 60 women and men aged 18–70 years with a BED diagnosis will be recruited. The Internet-based GSH treatment comprises eight sessions followed by three booster sessions. The placebo-inspired waitlist control group receives weekly messages containing information increasing positive expectations regarding the treatment effects during the four-week waiting period. The pure waitlist control group receives weekly messages simply asking patients to fill in a short questionnaire.

Discussion

The access to evidence-based treatments for BED might be made easier using an Internet-based GSH approach. The present study protocol presents a randomized controlled trial. As well as evaluating the suitability and efficacy of the Internet-based GSH treatment, there will also be a prelimarily investigation on the influence of positive expectations (placebo) for a therapeutic intervention on core symptoms.

Trial registration

German Clinical Trials Register, DRKS00012355. Registered on 14 September 2017.
Literature
1.
2.
Smink FRE, van Hoeken D, Hoek HW. Epidemiology, course, and outcome of eating disorders. Curr Opin Psychiatry. 2013;26(6):543–8.PubMedCrossRef
3.
Keski-Rahkonen A, Mustelin L. Epidemiology of eating disorders in Europe: prevalence, incidence, comorbidity, course, consequences, and risk factors. Curr Opin Psychiatry. 2016;29(6):340–5.PubMedCrossRef
4.
Schnyder U, Milos G, Mohler-Kuo M, Dermota P. Prävalenz von Essstörungen in der Schweiz. Bundesamt für Gesundheit (BAG). 2012.
5.
Cossrow N, Pawaskar M, Witt EA, Ming EE, Victor TW, Herman BK, et al. Estimating the prevalence of binge eating disorder in a community sample from the United States: comparing DSM-IV-TR and DSM-5 criteria. J Clin Psychiatry. 2016;77(8):e968–74.PubMedCrossRef
6.
Kessler RC, Berglund PA, Chiu WT, Deitz AC, Hudson JI, Shahly V, et al. The prevalence and correlates of binge eating disorder in the World Health Organization World Mental Health Surveys. Biol Psychiatry. 2013;73(9):904–14.PubMedPubMedCentralCrossRef
7.
Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the national comorbidity survey replication. Biol Psychiatry. 2007;61(3):348–58.PubMedCrossRef
8.
Regan P, Cachelin FM, Minnick AM. Initial treatment seeking from professional health care providers for eating disorders: A review and synthesis of potential barriers to and facilitators of “first contact”. Int J Eat Disord. 2017;50:190–209.PubMedCrossRef
9.
Burns JM, Durkin LA, Nicholas J. Mental health of young people in the United States: what role can the internet play in reducing stigma and promoting help seeking? J Adolesc Health. 2009;45(1):95–7.PubMedCrossRef
10.
Stocker D, Stettler P, Jäggi J, Bischof S, Guggenbühl T, Abrassart A, Rüesch P, Künzi K. Versorgungssituation psychisch erkrankter Personen in der Schweiz. Büro für arbeits-und sozialpolitische Studien BASS. 2016.
11.
12.
Munsch S, Biedert E, Meyer A, Michael T, Schlup B, Tuch A, et al. A randomized comparison of cognitive behavioral therapy and behavioral weight loss treatment for overweight individuals with binge eating disorder. Int J Eat Disord. 2007;40(2):102–13.PubMedCrossRef
13.
Munsch S, Meyer AH, Biedert E. Efficacy and predictors of long-term treatment success for cognitive-behavioral treatment and behavioral weight-loss-treatment in overweight individuals with binge eating disorder. Behav Res Ther. 2012;50(12):775–85.PubMedCrossRef
14.
Schlup B, Munsch S, Meyer AH, Margraf J, Wilhelm FH. The efficacy of a short version of a cognitive-behavioral treatment followed by booster sessions for binge eating disorder. Behav Res Ther. 2009;47(7):628–35.PubMedCrossRef
15.
Fischer S, Meyer AH, Dremmel D, Schlup B, Munsch S. Short-term cognitive-behavioral therapy for binge eating disorder: long-term efficacy and predictors of long-term treatment success. Behav Res Ther. 2014;58:36–42.PubMedCrossRef
16.
Grilo CM. Psychological and behavioral treatments for binge-eating disorder. J Clin Psychiatry. 2017;78:20–4.
17.
Cooper Z, Allen E, Bailey-Straebler S, Basden S, Murphy R, O’Connor ME, et al. Predictors and moderators of response to enhanced cognitive behaviour therapy and interpersonal psychotherapy for the treatment of eating disorders. Behav Res Ther. 2016;84:9–13.PubMedPubMedCentralCrossRef
18.
Wilson GT, Zandberg LJ. Cognitive-behavioral guided self-help for eating disorders: effectiveness and scalability. Clin Psychol Rev. 2012;32(4):343–57.PubMedCrossRef
19.
Vocks S, Tuschen-Caffier B, Pietrowsky R, Rustenbach SJ, Kersting A, Herpertz S. Meta-analysis of the effectiveness of psychological and pharmacological treatments for binge eating disorder. Int J Eat Disord. 2010;43(3):205–17.PubMed
20.
Jones M, Luce KH, Osborne MI, Taylor K, Cunning D, Doyle AC, et al. Randomized, controlled trial of an internet-facilitated intervention for reducing binge eating and overweight in adolescents. Pediatrics. 2008;121(3):453–62.PubMedCrossRef
21.
Bauer S, Moessner M. Harnessing the power of technology for the treatment and prevention of eating disorders. Int J Eat Disord. 2013;46(5):508–15.PubMedCrossRef
22.
Aardoom JJ, Dingemans AE, Spinhoven P, Van Furth EF. Treating eating disorders over the internet: a systematic review and future research directions. Int J Eat Disord. 2013;46(6):539–52.PubMedCrossRef
23.
Dölemeyer R, Tietjen A, Kersting A, Wagner B. Internet-based interventions for eating disorders in adults: a systematic review. BMC Psychiatry. 2013;13(1):207.PubMedPubMedCentralCrossRef
24.
Schlegl S, Burger C, Schmidt L, Herbst N, Voderholzer U. The potential of technology-based psychological interventions for anorexia and bulimia nervosa: a systematic review and recommendations for future research. J Med Internet Res. 2015;17(3):e85.PubMedPubMedCentralCrossRef
25.
Carrard I, Crepin C, Rouget P, Lam T, Golay A, Van der Linden M. Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. Behav Res Ther. 2011;49(8):482–91.PubMedCrossRef
26.
Carrard I, Crepin C, Rouget P, Lam T, Van der Linden M, Golay A. Acceptance and efficacy of a guided internet self-help treatment program for obese patients with binge eating disorder. Clin Pract Epidemiol Ment Health. 2011;7:8–18.PubMedCrossRef
27.
de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich HC, Schmidt F, et al. INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. Trials. 2012;13:220.PubMedPubMedCentralCrossRef
28.
de Zwaan M, Herpertz S, Zipfel S, Svaldi J, Friederich HC, Schmidt F, et al. Effect of internet-based guided self-help vs individual face-to-face treatment on full or subsyndromal binge eating disorder in overweight or obese patients: The INTERBED randomized clinical trial. JAMA Psychiatry. 2017;74(10):987–95.PubMedPubMedCentralCrossRef
29.
30.
Brauhardt A, de Zwaan M, Herpertz S, Zipfel S, Svaldi J, Friederich HC, et al. Therapist adherence in individual cognitive-behavioral therapy for binge-eating disorder: Assessment, course, and predictors. Behav Res Ther. 2014;61:55–60.PubMedCrossRef
31.
Rief W, Glombiewski JA. Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie. 2016;26(1):47–54.CrossRef
32.
33.
Greenberg RP, Constantino MK, Bruce N. Are patient expectations still relevant for psychotherapy process and outcome? Clin Psychol Rev. 2006;26(6):657–78.PubMedCrossRef
34.
Linden M. Placebo: unsolved problems for science, and simple conclusions for clinical practice. Am J Psychiatr. 2017;174(2):91–2.PubMedCrossRef
35.
Fuertes JN, Anand P, Haggerty G, Kestenbaum M, Rosenblum GC. The physician-patient working alliance and patient psychological attachment, adherence, outcome expectations, and satisfaction in a sample of rheumatology patients. Behav Med. 2015;41(2):60–8.PubMedCrossRef
36.
Lewin AB, Peris TS, Lindsey Bergman R, JT MC, Piacentini J. The role of treatment expectancy in youth receiving exposure-based CBT for obsessive compulsive disorder. Behav Res Ther. 2011;49(9):536–43.PubMedPubMedCentralCrossRef
37.
Cuijpers P, Cristea IA. What if a placebo effect explained all the activity of depression treatments? World Psychiatry. 2015;14(3):3101–311.CrossRef
38.
Wyssen A, Forrer F, Meyer AH, Munsch S. Wirksamkeit eines angeleiteten kognitiv-verhaltenstherapeutischen Selbsthilfeprogramms zur Behandlung der Binge-Eating-Störung. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie. 2019;67(1):1–12. https://​doi.​org/​10.​1024/​1661-4747/​a000371.
39.
Munsch S, Wyssen A, Biedert E. In: dritte, vollständig überarbeitete Auflage, editor. Binge Eating - Kognitive Verhaltenstherapie bei Essanfällen. Weinheim: Beltz Verlag; 2018.
40.
Currie SL, McGrath PJ, Day V. Development and usability of an online CBT program for symptoms of moderate depression, anxiety, and stress in post-secondary students. Comput Hum Behav. 2010;26(6):1419–26.CrossRef
41.
Yu CH, Parsons JA, Hall S, Newton D, Jovicic A, Lottridge D, et al. User-centered design of a web-based self-management site for individuals with type 2 diabetes - providing a sense of control and community. BMC Med Inform Decis Mak. 2014;14:60.PubMedPubMedCentralCrossRef
42.
Garrett JJ. Elements of User Experience, The: User-Centered Design for the Web and Beyond. Berkeley: Pearson Education; 2010.
43.
Bate P, Robert G. Toward more user-centric OD: lessons from the field of experience-based design and a case study. J Appl Behav Sci. 2007;43(1):41–66.CrossRef
44.
Hilbert A, Tuschen-Caffier B, Karwautz A, Niederhofer H, Munsch S. Eating disorder examination-questionnaire: Psychometric properties of the German version. Diagnostica. 2007;53(3):144–54.CrossRef
45.
46.
Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988;9(4):365–74.PubMedCrossRef
47.
Dölemeyer R, Klinitzke G, Steinig J, Wagner B, Kersting A. Working alliance in internet-based therapy for binge eating disorder. Psychiatr Prax. 2013;40(6):321–6.PubMedCrossRef
48.
Munsch S, Wyssen A. Das Leben verschlingen. Strategien gegen Essanfälle. Audio-Ratgeber mit Übungen. Weinheim: Beltz Verlag; 2014.
49.
Munsch S, Wyssen A, Biedert E. Das Leben verschlingen?: Hilfe für Betroffene mit Binge-Eating-Störung (Essanfällen) und deren Angehörige. Mit Online-Materialien. Weinheim: Beltz Verlag; 2018.
50.
Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. Hoboken: Vol. 998: Wiley; 2012.
51.
Preacher KJ, Zyphur MJ, Zhang Z. A general multilevel SEM framework for assessing multilevel mediation. Psychol Methods. 2010;15(3):209.PubMedCrossRef
52.
Dumas B, Signer B, Lalanne D. Fusion in multimodal interactive systems: an HMM-based algorithm for user-induced adaptation. In: Proceedings of the 4th ACM SIGCHI symposium on Engineering interactive computing systems. New York: ACM; 2012.
53.
Margraf J, Cwik JC. Mini-DIPS Open Access: Diagnostisches Kurzinterview bei psychischen Störungen. Bochum: Forschungs- und Behandlungszentrum für psychische Gesundheit, Ruhr-Universität Bochum; 2017.
54.
Hilbert A, Tuschen-Caffier B. Eating Disorder Examination: Deutschsprachige Übersetzung. Münster: Verlag für Psychotherapie; 2016.
55.
NIMH. CGI. Clinical Global Impressions. In: Guy W, editor. ECDEU Assessment for psychopharmacology. Rockville: National Institute of Mental Health; 1976. p. 217–22.
56.
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.PubMedCrossRef
57.
Ferring D, Filipp S-H. Messung des Selbstwertgefühls: Befunde zu Reliabilität, Validität und Stabilität der Rosenberg-Skala. Diagnostica Gottingen. 1996;42:284–92.
58.
Beierlein C, Kovaleva A, Kemper CJ, Rammstedt B. Ein Messinstrument zur Erfassung subjektiver Kompetenzerwartungen: Allgemeine Selbstwirksamkeit Kurzskala (ASKU). 2012.
59.
Mehrabian A. Evidence bearing on the affiliative tendency (MAFF) and sensitivity to rejection (MSR) scales. Curr Psychol. 1994;13(2):97–116.CrossRef
60.
Hautzinger M, Kühner C, Keller F. In: zweite Auflage, editor. BDI-II: Beck Depressionsfragebogen-II. Frankfurt: Pearson Assessment & Informations GmbH; 2006.
61.
Beck AT, Brown GK, Steer RA. Beck-Depressions-Inventar-FS (BDI-FS). Deutsche Bearbeitung von Sören Kliem & Elmar Brähler. Frankfurt am Main: Pearson Assessment; 2013.
62.
Margraf J, Ehlers A. Das Beck Angst-Inventar (BAI) – Manual. Deutsche Bearbeitung. Frankfurt: Harcourt Test Services GmbH; 2007.
63.
Hilbert A, Tuschen-Caffier B. Eating Disorder Examination-Questionnaire: Deutschsprachige Übersetzung. Münster: Verlag für Psychotherapie; 2016.
64.
Grunert S. Ein Inventar zur Erfassung von Selbstaussagen zum Ernährungsverhalten. Diagnostica. 1989;35:167–79.
65.
Wyssen A, Debbeler LJ, Meyer AH, Coelho JS, Humbel N, Schuck K, et al. Relevance of the Thought-Shape Fusion Trait Questionnaire for healthy women and women presenting symptoms of eating disorders and mixed mental disorders. Clin Psychol Psychother. 2018;25(4):601–7.
66.
Meule A, Lutz A, Vogele C, Kubler A. Food cravings discriminate differentially between successful and unsuccessful dieters and non-dieters. Validation of the Food Cravings Questionnaires in German. Appetite. 2012;58(1):88–97.PubMedCrossRef
67.
Ehring T, Fischer S, Schnulle J, Bosterling A, Tuschen-Caffier B. Characteristics of emotion regulation in recovered depressed versus never depressed individuals. Personal Individ Differ. 2008;44(7):1574–84.CrossRef
68.
Rozental A, Kottorp A, Boettcher J, Andersson G, Carlbring P. Negative effects of psychological treatments: an exploratory factor analysis of the Negative Effects Questionnaire for monitoring and reporting adverse and unwanted events. PLoS One. 2016;11(6):e0157503.PubMedPubMedCentralCrossRef
69.
Wilmers F, et al. Die deutschsprachige Version des Working Alliance Inventory – short revised (WAI-SR) – Ein schulenübergreifendes, ökonomisches und empirisch validiertes Instrument zur Erfassung der therapeutischen Allianz. Klinische Diagnostik und Evaluation. 2008;1:343–58.
70.
Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: Adding an adjective rating scale. J Usability Stud. 2009;4(3):114–23.
71.
Oliver MB, Bartsch A. Appreciation as audience response: Exploring entertainment gratifications beyond hedonism. Hum Commun Res. 2010;36(1):53–81.CrossRef
72.
Bartsch A. Emotional gratification in entertainment experience. Why viewers of movies and television series find it rewarding to experience emotions. Media Psychol. 2012;15(3):267–302.CrossRef
Metadata
Title
Binge-eating disorder treatment goes online – feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group
Authors
Simone Munsch
Andrea Wyssen
Pierre Vanhulst
Denis Lalanne
Sharon T. Steinemann
Alexandre Tuch
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3192-z

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer’s Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol

Study protocol

Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback

Correction

Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Correction

Correction to: Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a steppedwedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

Study protocol

Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial

Research

Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial