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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Bank of Austria
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00461071
First received: April 16, 2007
Last updated: September 17, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: RCT on the Use of Psychoeducation for Bulimia Nervosa in Young Women

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Eating disorder symptomatology after 3 months and after 7 months [ Time Frame: december 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictors for best outcome [ Time Frame: december 2009 ] [ Designated as safety issue: No ]
  • motivation for change [ Time Frame: dec 2009 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2007
Estimated 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

Ages Eligible for Study:   16 Years to 30 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Austrian National Bank, Jubiläumsfonds, Jubiläumsfonds
ClinicalTrials.gov Identifier: NCT00461071     History of Changes
Other Study ID Numbers: AP11957ONB
Study First Received: April 16, 2007
Last Updated: September 17, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by 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
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014