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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00378248
Other study ID # UPP
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 18, 2006
Last updated November 26, 2013
Start date May 2004
Est. completion date December 2016

Study information

Verified date November 2013
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: "Ullevål University Hospital"
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Combined psychotherapy
18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
Outpatient individual psychotherapy
Eclectic individual psychotherapy in private practice

Locations

Country Name City State
Norway Department for personality psychiatry, Psychiatric division, Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Arnevik E, Wilberg T, Urnes Ø, Johansen M, Monsen JT, Karterud S. Psychotherapy for personality disorders: 18 months' follow-up of the ullevål personality project. J Pers Disord. 2010 Apr;24(2):188-203. doi: 10.1521/pedi.2010.24.2.188. — View Citation

Arnevik E, Wilberg T, Urnes O, Johansen M, Monsen JT, Karterud S. Psychotherapy for personality disorders: short-term day hospital psychotherapy versus outpatient individual therapy - a randomized controlled study. Eur Psychiatry. 2009 Mar;24(2):71-8. doi — View Citation

Gullestad FS, Johansen MS, Høglend P, Karterud S, Wilberg T. Mentalization as a moderator of treatment effects: findings from a randomized clinical trial for personality disorders. Psychother Res. 2013;23(6):674-89. doi: 10.1080/10503307.2012.684103. Epub — View Citation

Gullestad FS, Wilberg T, Klungsøyr O, Johansen MS, Urnes O, Karterud S. Is treatment in a day hospital step-down program superior to outpatient individual psychotherapy for patients with personality disorders? 36 months follow-up of a randomized clinical — View Citation

Gullestad FS, Wilberg T. Change in reflective functioning during psychotherapy--a single-case study. Psychother Res. 2011 Jan;21(1):97-111. doi: 10.1080/10503307.2010.525759. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychosocial functioning The outcomes will be assessed after 8, 18, 36, and 72 months: No
Primary symptom distress after 8, 18, 36 and 72 months No
Primary self esteem after 8, 18, 36 and 72 months No
Primary interpersonal problems, after 8, 18, 36 and 72 months No
Primary self destructive behavior, after 8, 18, 36 and 72 months No
Primary personality pathology, after 36 and 72 months No
Primary quality of life, after 8, 18, 36 and 72 months No
Primary health care utilization after after 8, 18, 36 and 72 months No
Secondary affect consciousness after 36 months No
Secondary reflective functioning after 36 months No
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