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Ullevål PersonalityProject

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ClinicalTrials.gov Identifier: NCT00378248
Recruitment Status : Unknown
Verified November 2013 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2006
Last Update Posted : November 27, 2013
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital

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 Not Applicable

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  (Clinical Trial)
Estimated 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 2004
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Psychosocial functioning [ Time Frame: The outcomes will be assessed after 8, 18, 36, and 72 months: ]
  2. symptom distress [ Time Frame: after 8, 18, 36 and 72 months ]
  3. self esteem [ Time Frame: after 8, 18, 36 and 72 months ]
  4. interpersonal problems, [ Time Frame: after 8, 18, 36 and 72 months ]
  5. self destructive behavior, [ Time Frame: after 8, 18, 36 and 72 months ]
  6. personality pathology, [ Time Frame: after 36 and 72 months ]
  7. quality of life, [ Time Frame: after 8, 18, 36 and 72 months ]
  8. health care utilization after [ Time Frame: after 8, 18, 36 and 72 months ]

Secondary Outcome Measures :
  1. affect consciousness [ Time Frame: after 36 months ]
  2. reflective functioning [ Time Frame: after 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

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