NCT01204346

Brief Summary

Mentalisation based treatment (MBT) for young people with co-morbid depression and emerging personality disorder will be more effective in a day/inpatient setting than treatment as usual.

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
75

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable depression

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

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
6 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

October 3, 2014

Status Verified

July 1, 2011

Enrollment Period

6 years

First QC Date

September 16, 2010

Last Update Submit

October 2, 2014

Conditions

DepressionPersonality Disorder

Keywords

adolescentsMBTdepressionemerging personality disorder

Outcome Measures

Primary Outcomes (3)

  • Global assessment of functioning

    Measures global functioning

    2 years post discharge

  • Global assessment of functioning

    measures level of functioning

    within 1 week of admission

  • global assessment of functioning

    measures level of functioning

    Average of 8 weeks

Secondary Outcomes (3)

  • mood and feelings questionnaire

    2 years post discharge

  • Mood and feelings questionnaire

    Within 1 week of admission

  • mood and feelings questionnaire

    At average of 8 weeks

Study Arms (2)

MBT group

EXPERIMENTAL

mentalization based treatment program

Other: MBT

Treatment as usual group

ACTIVE COMPARATOR

treatment as usual group

Other: treatment as usual

Interventions

MBTOTHER

The intervention consists of twice weekly individual MBT therapy, group therapy with an MBT focus and weekly MBFT, which is MBT for families. The treatment duration will be 6-8 weeks.

Also known as: Psychotherapeutic program
MBT group
treatment as usualOTHER

less intensive and structured psychotherapeutic program

Also known as: Psychotherapeutic program
Treatment as usual group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all young people who are admitted to Brookside adolescent unit between the ages 12 - 17 presenting with depression and emerging personality disorder will be eligible

You may not qualify if:

  • Young people with autistic spectrum disorders or severe learning disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North East London Foundation Trust

Ilford, Essex, IG3 8XQ, United Kingdom

RECRUITING

Related Publications (7)

  • Bateman A, Fonagy P. Mentalization based treatment for borderline personality disorder. World Psychiatry. 2010 Feb;9(1):11-5. doi: 10.1002/j.2051-5545.2010.tb00255.x.

    PMID: 20148147BACKGROUND

  • Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.

    PMID: 19833787BACKGROUND

  • Crawford TN, Cohen P, First MB, Skodol AE, Johnson JG, Kasen S. Comorbid Axis I and Axis II disorders in early adolescence: outcomes 20 years later. Arch Gen Psychiatry. 2008 Jun;65(6):641-8. doi: 10.1001/archpsyc.65.6.641.

    PMID: 18519822BACKGROUND

  • Kasen S, Cohen P, Skodol AE, Johnson JG, Brook JS. Influence of child and adolescent psychiatric disorders on young adult personality disorder. Am J Psychiatry. 1999 Oct;156(10):1529-35. doi: 10.1176/ajp.156.10.1529.

    PMID: 10518162BACKGROUND

  • Kasen S, Cohen P, Skodol AE, First MB, Johnson JG, Brook JS, Oldham JM. Comorbid personality disorder and treatment use in a community sample of youths: a 20-year follow-up. Acta Psychiatr Scand. 2007 Jan;115(1):56-65. doi: 10.1111/j.1600-0447.2006.00842.x.

    PMID: 17201867BACKGROUND

  • Lewinsohn PM, Rohde P, Klein DN, Seeley JR. Natural course of adolescent major depressive disorder: I. Continuity into young adulthood. J Am Acad Child Adolesc Psychiatry. 1999 Jan;38(1):56-63. doi: 10.1097/00004583-199901000-00020.

    PMID: 9893417BACKGROUND

  • Chanen AM, McCutcheon LK, Jovev M, Jackson HJ, McGorry PD. Prevention and early intervention for borderline personality disorder. Med J Aust. 2007 Oct 1;187(S7):S18-21. doi: 10.5694/j.1326-5377.2007.tb01330.x.

    PMID: 17908019BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionPersonality Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • trudie i rossouw, dr

    North East London Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

trudie I Rossouw, Dr

CONTACT

+448446001200trudie.rossouw@nelft.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 3, 2014

Record last verified: 2011-07

Locations

GB(1)