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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01204346
Other study ID # TRossouw
Secondary ID
Status Recruiting
Phase N/A
First received September 16, 2010
Last updated October 2, 2014
Start date December 2010
Est. completion date December 2016

Study information

Verified date July 2011
Source North East London Foundation Trust
Contact trudie I Rossouw, Dr
Phone +448446001200
Email trudie.rossouw@nelft.nhs.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Description:

Systematic literature review on outcomes with young people with depression and emerging personality disorder showed clear evidence that this group of young people are severely hampered and adult outcomes are strongly linked to both adult PD as well as adult psychiatric disturbance and lower levels of adult functioning. (Crawford et al, 2008; Kasen et al, 1999; Kasen et al, 2007; Lewinsohn et al, 1999) This argues very clearly for the need to diagnose young people presenting with co-morbid depression and emerging personality disorder in order to intervene and help these young people's struggles as it will prevent poor prognostic adult outcomes. There were no treatment programs that specifically focussed on the treatment of this co-morbid group in the literature. Several studies focussed on the treatment of depression alone and only one RCT focussed on the treatment of adolescent personality disorder (Chanen et al, 2007). In adult studies mentalization-based treatment programs were found to be effective ( as well as cost effective) in a day hospital setting for adults with personality disorder and depression (Bateman, et al, 2007) This study aims to conduct a control trial to test whether MBT will be more effective than TAU in this group. All cases will be tested on admission, at discharge and followed up at 2 years post discharge.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Other:
MBT
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.
treatment as usual
less intensive and structured psychotherapeutic program

Locations

Country Name City State
United Kingdom North East London Foundation Trust Ilford Essex

Sponsors (1)

Lead Sponsor Collaborator
North East London Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Bateman A, Fonagy P. Mentalization based treatment for borderline personality disorder. World Psychiatry. 2010 Feb;9(1):11-5. — View Citation

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. — View Citation

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(7 Suppl):S18-21. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Global assessment of functioning Measures global functioning 2 years post discharge No
Primary Global assessment of functioning measures level of functioning within 1 week of admission No
Primary global assessment of functioning measures level of functioning Average of 8 weeks No
Secondary mood and feelings questionnaire Assesses mood in terms of number of depressive symptoms 2 years post discharge No
Secondary Mood and feelings questionnaire Assesses mood in terms of number of depressive symptoms Within 1 week of admission No
Secondary mood and feelings questionnaire Assesses mood in terms of number of depressive symptoms At average of 8 weeks No
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