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Personality DisordersNCT00378248

Ullevål PersonalityProject

A study testing Combined psychotherapy and Outpatient individual psychotherapy in people with Personality Disorders, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Personality Disorders
What is being tested?
Combined psychotherapy and Outpatient individual psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteNorway
Study dates
May 2004to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

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

    Oslo, 0407

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Combined psychotherapy, Outpatient individual psychotherapy
Keywords
Personality disorders,, Day treatment,, Group psychotherapy,, Combined psychotherapy,, Outcome,, Attachment pattern
Medical subject headings
Personality Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined psychotherapyBehavioural

    Also called CP

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

  • Outpatient individual psychotherapyBehavioural

    Also called OIP

    Eclectic individual psychotherapy in private practice

Study groups in NCT00378248
Study groupRoleWhat they receive
Combined psychotherapyExperimental18 weeks day hospital treatment followed by long-term outpatient combined group- and individual psychotherapy
Receives: Behavioral: Combined psychotherapy
Outpatient individual psychotherapyActive comparatorEclectic individual psychotherapy in outpatient private practice
Receives: Behavioral: Outpatient individual psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychosocial functioning

    Measured: The outcomes will be assessed after 8, 18, 36, and 72 months:

  2. symptom distress

    Measured: after 8, 18, 36 and 72 months

  3. self esteem

    Measured: after 8, 18, 36 and 72 months

  4. interpersonal problems,

    Measured: after 8, 18, 36 and 72 months

  5. self destructive behavior,

    Measured: after 8, 18, 36 and 72 months

  6. personality pathology,

    Measured: after 36 and 72 months

  7. quality of life,

    Measured: after 8, 18, 36 and 72 months

  8. health care utilization after

    Measured: after 8, 18, 36 and 72 months

Secondary outcomes (2)

  1. affect consciousness

    Measured: after 36 months

  2. reflective functioning

    Measured: after 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2006 (estimated)
  2. Study startMay 2004
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378248
Sponsor's protocol ID
UPP
Status last verified
Nov 2013
First submitted
18 Sep 2006
Last updated
27 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 19097870

  • 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.

    PubMed 20420475

  • 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.

    PubMed 22417131

  • 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.

    PubMed 22612470

  • 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.

    PubMed 21331977

  • 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.

    PubMed 32880104

  • 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.

    PubMed 32368793

  • 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.

    PubMed 28583098

  • 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.

    PubMed 24758722

  • 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.

    PubMed 24268099

Questions about this trial

What is this clinical trial studying?

A study testing Combined psychotherapy and Outpatient individual psychotherapy in people with Personality Disorders, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychosocial functioning (time frame: The outcomes will be assessed after 8, 18, 36, and 72 months:). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378248, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.

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