NCT00378248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

12.6 years

First QC Date

September 18, 2006

Last Update Submit

November 26, 2013

Conditions

Personality Disorders

Keywords

Personality disorders,Day treatment,Group psychotherapy,Combined psychotherapy,Outcome,Attachment pattern

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (2)

  • affect consciousness

    after 36 months

  • reflective functioning

    after 36 months

Study Arms (2)

Combined psychotherapy

EXPERIMENTAL

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

Behavioral: Combined psychotherapy

Outpatient individual psychotherapy

ACTIVE COMPARATOR

Eclectic individual psychotherapy in outpatient private practice

Behavioral: Outpatient individual psychotherapy

Interventions

Combined psychotherapyBEHAVIORAL

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

Also known as: CP
Combined psychotherapy
Outpatient individual psychotherapyBEHAVIORAL

Eclectic individual psychotherapy in private practice

Also known as: OIP
Outpatient individual psychotherapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with personality disorders admitted to Department for personality psychiatry, Psychiatric division, Ullevål University Hospital

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for personality psychiatry, Psychiatric division, Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (10)

  • 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.

    PMID: 19097870RESULT

  • 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.

    PMID: 20420475RESULT

  • 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.

    PMID: 22417131RESULT

  • 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.

    PMID: 22612470RESULT

  • 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.

    PMID: 21331977RESULT

  • 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.

    PMID: 32880104DERIVED

  • 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.

    PMID: 32368793DERIVED

  • 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.

    PMID: 28583098DERIVED

  • 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.

    PMID: 24758722DERIVED

  • 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.

    PMID: 24268099DERIVED

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Theresa Wilberg, M.D.Ph.D.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

May 1, 2004

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

NO(1)