Ullevål PersonalityProject

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00378248
First received: September 18, 2006
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Personality Disorders
Behavioral: Combined psychotherapy
Behavioral: Outpatient individual psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Psychosocial functioning [ Time Frame: The outcomes will be assessed after 8, 18, 36, and 72 months: ] [ Designated as safety issue: No ]
  • symptom distress [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]
  • self esteem [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]
  • interpersonal problems, [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]
  • self destructive behavior, [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]
  • personality pathology, [ Time Frame: after 36 and 72 months ] [ Designated as safety issue: No ]
  • quality of life, [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]
  • health care utilization after [ Time Frame: after 8, 18, 36 and 72 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • affect consciousness [ Time Frame: after 36 months ] [ Designated as safety issue: No ]
  • reflective functioning [ Time Frame: after 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2004
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CP
Active Comparator: Outpatient individual psychotherapy
Eclectic individual psychotherapy in outpatient private practice
Behavioral: Outpatient individual psychotherapy
Eclectic individual psychotherapy in private practice
Other Name: OIP

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378248

Locations
Norway
Department for personality psychiatry, Psychiatric division, Oslo University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Theresa Wilberg, M.D.Ph.D. Oslo University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00378248     History of Changes
Other Study ID Numbers: UPP
Study First Received: September 18, 2006
Last Updated: November 26, 2013
Health Authority: Norway: "Ullevål University Hospital"

Keywords provided by Oslo University Hospital:
Personality disorders,
Day treatment,
Group psychotherapy,
Combined psychotherapy,
Outcome,
Attachment pattern

Additional relevant MeSH terms:
Personality Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014