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A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184301
First received: September 13, 2005
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

The aim of this study is to determine whether in-patient treatment is better then intensive out-patient group treatment for patients with concurrent eating disorder and personality disorder.


Condition Intervention
Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Personality Disorder
 Behavioral: inpatient treatment
Behavioral: outpatient treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Treatment of Patients With Concurrent Eating Disorder and Personality Disorder: A Controlled Randomized Comparison Study, of Treatments Given to In-patients and Out-patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Score on personality, interpersonal, eating disorder and symptom scales [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inpatient treatment
inpatient treatment during 1 year
 Behavioral: inpatient treatment
inpatient treatment during 1 year
Active Comparator: outpatient treatment
intensive outpatient treatment consisting of two-weekly group sessions during 1 year
 Behavioral: outpatient treatment
intensive outpatient treatment consisting of two-weekly group sessions during 1 year

Detailed Description:

The main aim of the study is to compare the effects of in-patient treatment with a group based intensive out-patient treatment. It is a randomized controlled comparison study including patients with concurrent eating disorder and personality disorder. 18 patients will receive an in-patient treatment lasting one year. 18 patients will receive intensive out-patient treatment consisting of two-weekly group sessions, lasting one year. Personality disorder, eating behavior, symptoms, and function will be followed for two years.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anorexia nervosa, bulimia nervosa, personality disorder.

Exclusion Criteria:

  • male, schizophrenia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184301

Locations
Norway
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trhodheim.
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Are Holen, PhD MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184301     History of Changes
Other Study ID Numbers: 064.03
Study First Received: September 13, 2005
Last Updated: May 11, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Eating disorders
Anorexia nervosa
Bulimia nervosa
Personality disorders
 In-patient treatment
out-patient treatment
group therapy

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

ClinicalTrials.gov processed this record on May 19, 2013