- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204346
Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder (MBT)
October 2, 2014 updated by: Trudie Rossouw, North East London Foundation Trust
Mentalization - Based Treatment for Young People Presenting With Co-morbid Depression and Symptoms of Emerging Personality Disorder: Prospective Controlled Trial.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: trudie I Rossouw, Dr
- Phone Number: +448446001200
- Email: trudie.rossouw@nelft.nhs.uk
Study Locations
-
-
Essex
-
Ilford, Essex, United Kingdom, IG3 8XQ
- Recruiting
- North east london foundation trust
-
Contact:
- trudie i rossouw, dr
- Phone Number: +448446001200
-
Principal Investigator:
- trudie i rossouw, dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBT group
mentalization based treatment program
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Treatment as usual group
treatment as usual group
|
less intensive and structured psychotherapeutic program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global assessment of functioning
Time Frame: 2 years post discharge
|
Measures global functioning
|
2 years post discharge
|
Global assessment of functioning
Time Frame: within 1 week of admission
|
measures level of functioning
|
within 1 week of admission
|
global assessment of functioning
Time Frame: Average of 8 weeks
|
measures level of functioning
|
Average of 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mood and feelings questionnaire
Time Frame: 2 years post discharge
|
Assesses mood in terms of number of depressive symptoms
|
2 years post discharge
|
Mood and feelings questionnaire
Time Frame: Within 1 week of admission
|
Assesses mood in terms of number of depressive symptoms
|
Within 1 week of admission
|
mood and feelings questionnaire
Time Frame: At average of 8 weeks
|
Assesses mood in terms of number of depressive symptoms
|
At average of 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: trudie i rossouw, dr, North east london foundation trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ANTICIPATED)
December 1, 2016
Study Completion (ANTICIPATED)
December 1, 2016
Study Registration Dates
First Submitted
September 16, 2010
First Submitted That Met QC Criteria
September 16, 2010
First Posted (ESTIMATE)
September 17, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 2, 2014
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRossouw
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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