Ullevål PersonalityProject

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00378248

Collaborator

South-Eastern Norway Regional Health Authority (Other)

120

Enrollment

Location

Arms

151

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Personality Disorders	Behavioral: Combined psychotherapy Behavioral: Outpatient individual psychotherapy	N/A

Detailed Description

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

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

The control treatment comprises:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

May 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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:

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

affect consciousness [after 36 months]
reflective functioning [after 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.