Ullevål PersonalityProject

November 26, 2013 updated by: Oslo University Hospital

Ullevål PersonalityProject. A Randomized Controlled Trial of Intensive Daytreatment Followed by Outpatient Long-term Combined Treatment Compared With Eclectic Individual Therapy for Patients With Personality Disorders

Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for patients with personality disorders.

The main study hypothesis is that long-term combined treatment is superior to eclectic individual therapy with respect to improvement in personality functioning, psychosocial functioning, symptoms, interpersonal problems, and self destructive behavior for poorly functioning patients with personality disorders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ullevål PersonalityProject is a ranomized controlled trial of treatment of patients with personality disorder. It's main purpose is to test the effect of a long-term combined treatment program compared with eclectic individual therapy for poorly functioning patients with personality disorders.

The experiment treatment is guided by written treatment guidelines and comprises:

  1. 18 weeks intensive day treatment
  2. followed by long-term outpatient combined group psychotherapy and individual therapy for 4 and 2,5 years respectively.

The control treatment comprises:

1. eclectic psychotherapy, here understood as psychotherapy according to the preference and regular practice of the therapist.

120 patients with personality disorders admitted to Department of personality psychiatry, Psychiatric division, Ullevål University Hospital are randomized to either experiment or control condition. The patients are evaluated at baseline and after 8, 18, 36, 72 months. The evaluations comprise a large battery of psychological tests and structured interviews.

Study Type

Interventional

Enrollment (Anticipated)

120

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
      • Oslo, Norway, 0407
        • Department for personality psychiatry, Psychiatric division, Oslo University Hospital

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with personality disorders admitted to Department for personality psychiatry, Psychiatric division, Ullevål University Hospital

Exclusion Criteria:

  • Schizotypal personality disorder, antisocial personaliy disorder, current alcohol or drug dependence, developmental disorders (e.g. Asperger), symptoms due to organic conditions, and lack of a permanent residence.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined psychotherapy
18 weeks day hospital treatment followed by long-term outpatient combined group- and individual psychotherapy
Behavioral: Combined psychotherapy
18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
Other Names:
  • CP
Active Comparator: Outpatient individual psychotherapy
Eclectic individual psychotherapy in outpatient private practice
Behavioral: Outpatient individual psychotherapy
Eclectic individual psychotherapy in private practice
Other Names:
  • OIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychosocial functioning
Time Frame: The outcomes will be assessed after 8, 18, 36, and 72 months:
The outcomes will be assessed after 8, 18, 36, and 72 months:
symptom distress
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months
self esteem
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months
interpersonal problems,
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months
self destructive behavior,
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months
personality pathology,
Time Frame: after 36 and 72 months
after 36 and 72 months
quality of life,
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months
health care utilization after
Time Frame: after 8, 18, 36 and 72 months
after 8, 18, 36 and 72 months

Secondary Outcome Measures

Outcome Measure
Time Frame
affect consciousness
Time Frame: after 36 months
after 36 months
reflective functioning
Time Frame: after 36 months
after 36 months

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Theresa Wilberg, M.D.Ph.D., Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2004

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPP

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.

Clinical Trials on Personality Disorders

Clinical Trials on Combined psychotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe