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

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT00184301
Collaborator
St. Olavs Hospital (Other), Norwegian Foundation for Health and Rehabilitation (Other)
43
Enrollment
1
Location
2
Arms
97
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: inpatient treatment
  • Behavioral: outpatient treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
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.
Actual Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Score on personality, interpersonal, eating disorder and symptom scales [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Anorexia nervosa, bulimia nervosa, personality disorder.
Exclusion Criteria:
  • male, schizophrenia.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184301
Other Study ID Numbers:
  • 064.03
First Posted:
Sep 16, 2005
Last Update Posted:
Mar 29, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
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
Anorexia
Bulimia
Feeding and Eating Disorders
Personality Disorders
Anorexia Nervosa
Bulimia Nervosa

Study Results

No Results Posted as of Mar 29, 2017