Back to resultsA 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
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
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
NCT ID
NCT00184301
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
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.
We'll reach out to this number within 24 hrs