Clinical trial NCT00378248: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Personality Disorders
Keywords: Personality disorders,
Day treatment,
Group psychotherapy,
Combined psychotherapy,
Outcome,
Attachment pattern
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2006-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Psychosocial functioning
timeFrame: The outcomes will be assessed after 8, 18, 36, and 72 months:
measure: symptom distress
timeFrame: after 8, 18, 36 and 72 months
measure: self esteem
timeFrame: after 8, 18, 36 and 72 months
measure: interpersonal problems,
timeFrame: after 8, 18, 36 and 72 months
measure: self destructive behavior,
timeFrame: after 8, 18, 36 and 72 months
measure: personality pathology,
timeFrame: after 36 and 72 months
measure: quality of life,
timeFrame: after 8, 18, 36 and 72 months
measure: health care utilization after
timeFrame: after 8, 18, 36 and 72 months
Secondary outcomes:
measure: affect consciousness
timeFrame: after 36 months
measure: reflective functioning
timeFrame: after 36 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department for personality psychiatry, Psychiatric division, Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Theresa Wilberg, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.