Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women
Primary Purpose
Bulimia Nervosa
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Guided Self-help for Bulimia nervosa
Sponsored by
About this trial
This is an interventional other trial for Bulimia Nervosa focused on measuring Bulimia nervosa, Guided Self-help, Psycho-education
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
Sites / Locations
- Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Internet-based self-help
Bibliotherapy
Arm Description
Internet-based self-help behavioural
bibliotherapy
Outcomes
Primary Outcome Measures
Eating disorder symptomatology after 3 months and after 7 months
Eating disorder symptomatology after 3 months and after 7 months
Secondary Outcome Measures
Predictors for best outcome
Predictors for best outcome
motivation for change
motivation for change
Full Information
NCT ID
NCT00461071
First Posted
April 16, 2007
Last Updated
September 28, 2017
Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
1. Study Identification
Unique Protocol Identification Number
NCT00461071
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
Bulimia nervosa, Guided Self-help, Psycho-education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based self-help
Arm Type
Active Comparator
Arm Description
Internet-based self-help behavioural
Arm Title
Bibliotherapy
Arm Type
Active Comparator
Arm Description
bibliotherapy
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-help for Bulimia nervosa
Intervention Description
bibliotherapy
Primary Outcome Measure Information:
Title
Eating disorder symptomatology after 3 months and after 7 months
Description
Eating disorder symptomatology after 3 months and after 7 months
Time Frame
december 2009
Secondary Outcome Measure Information:
Title
Predictors for best outcome
Description
Predictors for best outcome
Time Frame
december 2009
Title
motivation for change
Description
motivation for change
Time Frame
dec 2009
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Karwautz, MD, Prof
Organizational Affiliation
Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
25448409
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.
Results Reference
derived
PubMed Identifier
23609487
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.
Results Reference
derived
PubMed Identifier
23222037
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.
Results Reference
derived
Links:
URL
http://www.ess-stoerung.eu
Description
related Information
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Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women
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