NCT00184301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

6.3 years

First QC Date

September 13, 2005

Last Update Submit

March 28, 2017

Conditions

Eating DisorderAnorexia NervosaBulimia NervosaPersonality Disorder

Keywords

Eating disordersAnorexia nervosaBulimia nervosaPersonality disordersIn-patient treatmentout-patient treatmentgroup therapy

Outcome Measures

Primary Outcomes (1)

  • Score on personality, interpersonal, eating disorder and symptom scales

    2 years

Study Arms (2)

inpatient treatment

EXPERIMENTAL

inpatient treatment during 1 year

Behavioral: inpatient treatment

outpatient treatment

ACTIVE COMPARATOR

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

Behavioral: outpatient treatment

Interventions

inpatient treatmentBEHAVIORAL

inpatient treatment during 1 year

inpatient treatment
outpatient treatmentBEHAVIORAL

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

outpatient treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anorexia nervosa, bulimia nervosa, personality disorder.

You may not qualify if:

  • male, schizophrenia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trondheim, Norway

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia NervosaPersonality Disorders

Interventions

HospitalizationAmbulatory Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Are Holen, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Study Completion

October 1, 2013

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)