Overview

This trial is active, not recruiting.

Condition personality disorders
Treatments combined psychotherapy, outpatient individual psychotherapy
Sponsor Oslo University Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date May 2004
End date December 2016
Trial size 120 participants
Trial identifier NCT00378248, UPP

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
18 weeks day hospital treatment followed by long-term outpatient combined group- and individual psychotherapy
combined psychotherapy CP
18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
(Active Comparator)
Eclectic individual psychotherapy in outpatient private practice
outpatient individual psychotherapy OIP
Eclectic individual psychotherapy in private practice

Primary Outcomes

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

Secondary Outcomes

Measure
affect consciousness
time frame: after 36 months
reflective functioning
time frame: after 36 months

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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.

Additional Information

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
Principal investigator Theresa Wilberg, M.D.Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Oslo University Hospital.