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

Primary Purpose

Eating Disorder, Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
inpatient treatment
outpatient treatment
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorder focused on measuring Eating disorders, Anorexia nervosa, Bulimia nervosa, Personality disorders, In-patient treatment, out-patient treatment, group therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Anorexia nervosa, bulimia nervosa, personality disorder. Exclusion Criteria: male, schizophrenia.

Sites / Locations

  • Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inpatient treatment

outpatient treatment

Arm Description

inpatient treatment during 1 year

intensive outpatient treatment consisting of two-weekly group sessions during 1 year

Outcomes

Primary Outcome Measures

Score on personality, interpersonal, eating disorder and symptom scales

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 28, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Foundation for Health and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT00184301
Brief Title
A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Foundation for Health and Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Personality Disorder
Keywords
Eating disorders, Anorexia nervosa, Bulimia nervosa, Personality disorders, In-patient treatment, out-patient treatment, group therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inpatient treatment
Arm Type
Experimental
Arm Description
inpatient treatment during 1 year
Arm Title
outpatient treatment
Arm Type
Active Comparator
Arm Description
intensive outpatient treatment consisting of two-weekly group sessions during 1 year
Intervention Type
Behavioral
Intervention Name(s)
inpatient treatment
Intervention Description
inpatient treatment during 1 year
Intervention Type
Behavioral
Intervention Name(s)
outpatient treatment
Intervention Description
intensive outpatient treatment consisting of two-weekly group sessions during 1 year
Primary Outcome Measure Information:
Title
Score on personality, interpersonal, eating disorder and symptom scales
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anorexia nervosa, bulimia nervosa, personality disorder. Exclusion Criteria: male, schizophrenia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Are Holen, PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim.
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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