search
Back to results

Ullevål PersonalityProject

Primary Purpose

Personality Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Combined psychotherapy
Outpatient individual psychotherapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Personality Disorders focused on measuring Personality disorders,, Day treatment,, Group psychotherapy,, Combined psychotherapy,, Outcome,, Attachment pattern

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department for personality psychiatry, Psychiatric division, Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined psychotherapy

Outpatient individual psychotherapy

Arm Description

18 weeks day hospital treatment followed by long-term outpatient combined group- and individual psychotherapy

Eclectic individual psychotherapy in outpatient private practice

Outcomes

Primary Outcome Measures

Psychosocial functioning
symptom distress
self esteem
interpersonal problems,
self destructive behavior,
personality pathology,
quality of life,
health care utilization after

Secondary Outcome Measures

affect consciousness
reflective functioning

Full Information

First Posted
September 18, 2006
Last Updated
November 26, 2013
Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT00378248
Brief Title
Ullevål PersonalityProject
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority

4. Oversight

5. 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.
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: 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorders
Keywords
Personality disorders,, Day treatment,, Group psychotherapy,, Combined psychotherapy,, Outcome,, Attachment pattern

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined psychotherapy
Arm Type
Experimental
Arm Description
18 weeks day hospital treatment followed by long-term outpatient combined group- and individual psychotherapy
Arm Title
Outpatient individual psychotherapy
Arm Type
Active Comparator
Arm Description
Eclectic individual psychotherapy in outpatient private practice
Intervention Type
Behavioral
Intervention Name(s)
Combined psychotherapy
Other Intervention Name(s)
CP
Intervention Description
18 weeks day hospital treatment followed by long-term outpatient combined group-and individual psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Outpatient individual psychotherapy
Other Intervention Name(s)
OIP
Intervention Description
Eclectic individual psychotherapy in private practice
Primary Outcome Measure Information:
Title
Psychosocial functioning
Time Frame
The outcomes will be assessed after 8, 18, 36, and 72 months:
Title
symptom distress
Time Frame
after 8, 18, 36 and 72 months
Title
self esteem
Time Frame
after 8, 18, 36 and 72 months
Title
interpersonal problems,
Time Frame
after 8, 18, 36 and 72 months
Title
self destructive behavior,
Time Frame
after 8, 18, 36 and 72 months
Title
personality pathology,
Time Frame
after 36 and 72 months
Title
quality of life,
Time Frame
after 8, 18, 36 and 72 months
Title
health care utilization after
Time Frame
after 8, 18, 36 and 72 months
Secondary Outcome Measure Information:
Title
affect consciousness
Time Frame
after 36 months
Title
reflective functioning
Time Frame
after 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Wilberg, M.D.Ph.D.
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for personality psychiatry, Psychiatric division, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19097870
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: 10.1016/j.eurpsy.2008.09.004. Epub 2008 Dec 19.
Results Reference
result
PubMed Identifier
20420475
Citation
Arnevik E, Wilberg T, Urnes O, Johansen M, Monsen JT, Karterud S. Psychotherapy for personality disorders: 18 months' follow-up of the ulleval personality project. J Pers Disord. 2010 Apr;24(2):188-203. doi: 10.1521/pedi.2010.24.2.188.
Results Reference
result
PubMed Identifier
22417131
Citation
Gullestad FS, Wilberg T, Klungsoyr 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 trial comparing different treatment modalities. Psychother Res. 2012;22(4):426-41. doi: 10.1080/10503307.2012.662608. Epub 2012 Mar 15.
Results Reference
result
PubMed Identifier
22612470
Citation
Gullestad FS, Johansen MS, Hoglend 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 2012 May 21. Erratum In: Psychother Res. 2015;25(4):503.
Results Reference
result
PubMed Identifier
21331977
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.
Results Reference
result
PubMed Identifier
32880104
Citation
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
28583098
Citation
Klungsoyr O, Antonsen B, Wilberg T. Contours of a causal feedback mechanism between adaptive personality and psychosocial function in patients with personality disorders: a secondary analysis from a randomized clinical trial. BMC Psychiatry. 2017 Jun 5;17(1):210. doi: 10.1186/s12888-017-1365-4.
Results Reference
derived
PubMed Identifier
24758722
Citation
Antonsen BT, Klungsoyr O, Kamps A, Hummelen B, Johansen MS, Pedersen G, Urnes O, Kvarstein EH, Karterud S, Wilberg T. Step-down versus outpatient psychotherapeutic treatment for personality disorders: 6-year follow-up of the Ulleval personality project. BMC Psychiatry. 2014 Apr 23;14:119. doi: 10.1186/1471-244X-14-119.
Results Reference
derived
PubMed Identifier
24268099
Citation
Kvarstein EH, Arnevik E, Halsteinli V, Ro FG, Karterud S, Wilberg T. Health service costs and clinical gains of psychotherapy for personality disorders: a randomized controlled trial of day-hospital-based step-down treatment versus outpatient treatment at a specialist practice. BMC Psychiatry. 2013 Nov 22;13:315. doi: 10.1186/1471-244X-13-315.
Results Reference
derived

Learn more about this trial

Ullevål PersonalityProject

We'll reach out to this number within 24 hrs