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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461071
First Posted: April 17, 2007
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Dr. Andreas Karwautz, Medical University of Vienna
  Purpose
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.

Condition Intervention
Bulimia Nervosa Behavioral: Guided Self-help for Bulimia nervosa

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: RCT on the Use of Psychoeducation for Bulimia Nervosa in Young Women

Further study details as provided by Dr. Andreas Karwautz, Medical University of Vienna:

Primary Outcome Measures:
  • Eating disorder symptomatology after 3 months and after 7 months [ Time Frame: december 2009 ]
    Eating disorder symptomatology after 3 months and after 7 months


Secondary Outcome Measures:
  • Predictors for best outcome [ Time Frame: december 2009 ]
    Predictors for best outcome

  • motivation for change [ Time Frame: dec 2009 ]
    motivation for change


Enrollment: 150
Study Start Date: April 2007
Study Completion Date: April 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Internet-based self-help
Internet-based self-help behavioural
Behavioral: Guided Self-help for Bulimia nervosa
bibliotherapy
Active Comparator: Bibliotherapy
bibliotherapy
Behavioral: Guided Self-help for Bulimia nervosa
bibliotherapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461071


Locations
Austria
Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
National Bank of Austria
Investigators
Study Director: Andreas Karwautz, MD, Prof Medical University of Vienna, Dep. of Children and Adolescent Psychiatry
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andreas Karwautz, Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00461071     History of Changes
Other Study ID Numbers: AP11957ONB
First Submitted: April 16, 2007
First Posted: April 17, 2007
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Dr. Andreas Karwautz, Medical University of Vienna:
Bulimia nervosa
Guided Self-help
Psycho-education

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders