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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184301
First Posted: September 16, 2005
Last Update Posted: March 29, 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.
Collaborators:
St. Olavs Hospital
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]

Enrollment: 43
Actual Study Start Date: September 2005
Study Completion Date: October 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anorexia nervosa, bulimia nervosa, personality disorder.

Exclusion Criteria:

  • male, schizophrenia.
  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): NCT00184301


Locations
Norway
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim.
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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184301     History of Changes
Other Study ID Numbers: 064.03
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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:
Disease
Feeding and Eating Disorders
Anorexia
Personality Disorders
Anorexia Nervosa
Bulimia
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia


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