Bulimia NervosaNCT00461071
Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women
A study testing Guided Self-help for Bulimia nervosa in people with Bulimia Nervosa, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Guided Self-help for Bulimia nervosa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of bulimia nervosa purging-type
- BMI > 18 or age corresponding BMI in patients younger than 18y.
- Access to Internet available
Who cannot join
- Severe depression, alcohol- or drug abuse
- acute suicidality
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
Vienna, 1090
About this study
Official title: RCT on the Use of Psychoeducation for Bulimia Nervosa in Young Women
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.
Read the 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.
- Conditions
- Bulimia Nervosa
- Being tested
- Guided Self-help for Bulimia nervosa
- Keywords
- Bulimia nervosa, Guided Self-help, Psycho-education
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-help for Bulimia nervosaBehavioural
bibliotherapy
| Study group | Role | What they receive |
|---|---|---|
| Internet-based self-help | Active comparator | Internet-based self-help behavioural Receives: Behavioral: Guided Self-help for Bulimia nervosa |
| Bibliotherapy | Active comparator | bibliotherapy Receives: Behavioral: Guided Self-help for Bulimia nervosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating disorder symptomatology after 3 months and after 7 months
Eating disorder symptomatology after 3 months and after 7 months
Measured: december 2009
Secondary outcomes (2)
Predictors for best outcome
Predictors for best outcome
Measured: december 2009
motivation for change
motivation for change
Measured: dec 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2008
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Dr. Andreas Karwautz, Medical University of Vienna
- Investigators
- Andreas Karwautz, MD, Prof, Study director, Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461071
- Sponsor's protocol ID
- AP11957ONB
- Status last verified
- Sep 2017
- First submitted
- 16 Apr 2007
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25448409Wagner 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.
PubMed 23609487Wagner 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.
PubMed 23222037
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT on the Use of Psychoeducation for Bulimia Nervosa in Young Women
- ClinicalTrials.gov ID
- NCT00461071
- Acronym / sponsor ID
- AP11957ONB
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia nervosa, Guided Self-help, Psycho-education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- Apr 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-help | Active comparator | Behavioral: Guided Self-help for Bulimia nervosaInternet-based self-help behavioural |
| Bibliotherapy | Active comparator | Behavioral: Guided Self-help for Bulimia nervosabibliotherapy |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of bulimia nervosa purging-type
- BMI > 18 or age corresponding BMI in patients younger than 18y.
- Access to Internet available
Key exclusion criteria (2 listed)
- Severe depression, alcohol- or drug abuse
- acute suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-help for Bulimia nervosabibliotherapy | Behavioural | Bibliotherapy, Internet-based self-help |
Primary outcome
Eating disorder symptomatology after 3 months and after 7 months
Time frame: december 2009
Eating disorder symptomatology after 3 months and after 7 months
2 secondary outcomes
Predictors for best outcome
Time frame: december 2009
motivation for change
Time frame: dec 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 25448409Wagner 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.
- Derived from this study: PubMed 23609487Wagner 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.
- Derived from this study: PubMed 23222037Wagner 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.
- related InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Karwautz, MD, Prof study director
Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-help for Bulimia nervosa in people with Bulimia Nervosa, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorder symptomatology after 3 months and after 7 months (time frame: december 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461071, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.