Ullevål PersonalityProject

Personality Disorders Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00378248
• Other study ID #: UPP
• 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

• Personality Disorders

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