Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women

NCT ID: NCT00461071

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bulimia Nervosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Internet-based self-help

Internet-based self-help behavioural

Group Type ACTIVE_COMPARATOR

Guided Self-help for Bulimia nervosa

Intervention Type BEHAVIORAL

bibliotherapy

Bibliotherapy

bibliotherapy

Group Type ACTIVE_COMPARATOR

Guided Self-help for Bulimia nervosa

Intervention Type BEHAVIORAL

bibliotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided Self-help for Bulimia nervosa

bibliotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Bank of Austria

OTHER_GOV

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Andreas Karwautz

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas Karwautz, MD, Prof

Role: STUDY_DIRECTOR

Medical University of Vienna, Dep. of Children and Adolescent Psychiatry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna, Dep. of Children and Adolescent Psychiatry

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25448409 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23609487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23222037 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ess-stoerung.eu

related Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AP11957ONB

Identifier Type: -

Identifier Source: org_study_id