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

March 28, 2017 updated by: Norwegian University of Science and Technology

Treatment of Patients With Concurrent Eating Disorder and Personality Disorder: A Controlled Randomized Comparison Study, of Treatments Given to In-patients and Out-patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Anorexia nervosa, bulimia nervosa, personality disorder.

Exclusion Criteria:

  • male, schizophrenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on personality, interpersonal, eating disorder and symptom scales
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Norwegian Foundation for Health and Rehabilitation

Investigators

  • Principal Investigator: Are Holen, PhD MD, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 064.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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