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Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder (MBT)

Primary Purpose

Depression, Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MBT
treatment as usual
Sponsored by
North East London Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring adolescents, MBT, depression, emerging personality disorder

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North East London Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBT group

Treatment as usual group

Arm Description

mentalization based treatment program

treatment as usual group

Outcomes

Primary Outcome Measures

Global assessment of functioning
Measures global functioning
Global assessment of functioning
measures level of functioning
global assessment of functioning
measures level of functioning

Secondary Outcome Measures

mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms
Mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms
mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms

Full Information

First Posted
September 16, 2010
Last Updated
October 2, 2014
Sponsor
North East London Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01204346
Brief Title
Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder
Acronym
MBT
Official Title
Mentalization - Based Treatment for Young People Presenting With Co-morbid Depression and Symptoms of Emerging Personality Disorder: Prospective Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North East London Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Personality Disorder
Keywords
adolescents, MBT, depression, emerging personality disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBT group
Arm Type
Experimental
Arm Description
mentalization based treatment program
Arm Title
Treatment as usual group
Arm Type
Active Comparator
Arm Description
treatment as usual group
Intervention Type
Other
Intervention Name(s)
MBT
Other Intervention Name(s)
Psychotherapeutic program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
treatment as usual
Other Intervention Name(s)
Psychotherapeutic program
Intervention Description
less intensive and structured psychotherapeutic program
Primary Outcome Measure Information:
Title
Global assessment of functioning
Description
Measures global functioning
Time Frame
2 years post discharge
Title
Global assessment of functioning
Description
measures level of functioning
Time Frame
within 1 week of admission
Title
global assessment of functioning
Description
measures level of functioning
Time Frame
Average of 8 weeks
Secondary Outcome Measure Information:
Title
mood and feelings questionnaire
Description
Assesses mood in terms of number of depressive symptoms
Time Frame
2 years post discharge
Title
Mood and feelings questionnaire
Description
Assesses mood in terms of number of depressive symptoms
Time Frame
Within 1 week of admission
Title
mood and feelings questionnaire
Description
Assesses mood in terms of number of depressive symptoms
Time Frame
At average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
trudie I Rossouw, Dr
Phone
+448446001200
Email
trudie.rossouw@nelft.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
trudie i rossouw, dr
Organizational Affiliation
North East London Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
North East London Foundation Trust
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG3 8XQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
trudie i rossouw, dr
Phone
+448446001200
First Name & Middle Initial & Last Name & Degree
trudie i rossouw, dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
20148147
Citation
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.
Results Reference
background
PubMed Identifier
19833787
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.
Results Reference
background
PubMed Identifier
18519822
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.
Results Reference
background
PubMed Identifier
10518162
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. doi: 10.1176/ajp.156.10.1529.
Results Reference
background
PubMed Identifier
17201867
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. doi: 10.1111/j.1600-0447.2006.00842.x.
Results Reference
background
PubMed Identifier
9893417
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. doi: 10.1097/00004583-199901000-00020.
Results Reference
background
PubMed Identifier
17908019
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(S7):S18-21. doi: 10.5694/j.1326-5377.2007.tb01330.x.
Results Reference
background
Links:
URL
http://www.nelft.nhs.uk/
Description
host NHS organisation

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Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder

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