Clinical trial NCT00461071: Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women
Official title: RCT on the Use of Psychoeducation for Bulimia Nervosa in Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: Bulimia nervosa
Guided Self-help
Psycho-education
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2007-04-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effectivity of guided self-help via Internet and bibliotherapy in the treatment of bulimia nervosa (BN) in young women.

Detailed description: Eating disorders and especially bulimia nervosa are psychiatric diseases, affecting 2-4% of women. An intervention such as guided self-help via manuals (bibliotherapy) is a well accepted approach and accepted. Development of new technologies in recent years allows delivery of psychotherapy via CD-ROMs and web-based interfaces. These new technologies have not yet been implemented in Austria in treating bulimia nervosa (BN) patients. In particular patients will be involved, who would not attend medical care regularly. The aim of our study is therefore to deliver guided self-help via an internet platform (supported by email contacts) for 100 patients with BN and to investigate the practicability and effectivity of this approach as well as compliance of patients in this group.

Patients will be found and contacted via internet, get specialized medical investigations, medical care and support via emails. As control group 100 patients with bulimia are treated with bibliotherapy only. Beside effectivity, predictors of outcome (clinical, comorbidity, indication to change, personality) are investigated.

The proposed study is a randomised controlled trial for effectivity and practicability of new technologies in psychiatric treatment research.

This is not a psychotherapy study but a study on psychoeducation, an approach which offers new and helpful opportunities for this patient group.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of bulimia nervosa purging-type
* BMI \> 18 or age corresponding BMI in patients younger than 18y.
* Access to Internet available

Exclusion Criteria:

* Severe depression, alcohol- or drug abuse
* acute suicidality

Primary outcomes:
measure: Eating disorder symptomatology after 3 months and after 7 months
timeFrame: december 2009
Secondary outcomes:
measure: Predictors for best outcome
timeFrame: december 2009
measure: motivation for change
timeFrame: dec 2009
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
Study officials:
affiliation: Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
name: Andreas Karwautz, MD, Prof
role: STUDY_DIRECTOR
References:
citation: Wagner G, Penelo E, Nobis G, Mayrhofer A, Wanner C, Schau J, Spitzer M, Gwinner P, Trofaier ML, Imgart H, Fernandez-Aranda F, Karwautz A. Predictors for good therapeutic outcome and drop-out in technology assisted guided self-help in the treatment of bulimia nervosa and bulimia like phenotype. Eur Eat Disord Rev. 2015 Mar;23(2):163-9. doi: 10.1002/erv.2336. Epub 2014 Dec 1.
citation: Wagner G, Wagner G, Penelo E, Nobis G, Mayerhofer A, Schau J, Spitzer M, Imgart H, Karwautz A. Is technology assisted guided self-help successful in treating female adolescents with bulimia nervosa? Neuropsychiatr. 2013;27(2):66-73. doi: 10.1007/s40211-013-0062-x. Epub 2013 Apr 23.
citation: Wagner G, Penelo E, Wanner C, Gwinner P, Trofaier ML, Imgart H, Waldherr K, Wober-Bingol C, Karwautz AF. Internet-delivered cognitive-behavioural therapy v. conventional guided self-help for bulimia nervosa: long-term evaluation of a randomised controlled trial. Br J Psychiatry. 2013 Feb;202:135-41. doi: 10.1192/bjp.bp.111.098582. Epub 2012 Dec 6.