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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by North East London Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North East London Foundation Trust
ClinicalTrials.gov Identifier:
NCT01204346
First received: September 16, 2010
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Depression
Personality Disorder
Other: MBT
Other: treatment as usual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Mentalization - Based Treatment for Young People Presenting With Co-morbid Depression and Symptoms of Emerging Personality Disorder: Prospective Controlled Trial.

Resource links provided by NLM:


Further study details as provided by North East London Foundation Trust:

Primary Outcome Measures:
  • Global assessment of functioning [ Time Frame: 2 years post discharge ] [ Designated as safety issue: No ]
    Measures global functioning

  • Global assessment of functioning [ Time Frame: within 1 week of admission ] [ Designated as safety issue: No ]
    measures level of functioning

  • global assessment of functioning [ Time Frame: Average of 8 weeks ] [ Designated as safety issue: No ]
    measures level of functioning


Secondary Outcome Measures:
  • mood and feelings questionnaire [ Time Frame: 2 years post discharge ] [ Designated as safety issue: No ]
    Assesses mood in terms of number of depressive symptoms

  • Mood and feelings questionnaire [ Time Frame: Within 1 week of admission ] [ Designated as safety issue: No ]
    Assesses mood in terms of number of depressive symptoms

  • mood and feelings questionnaire [ Time Frame: At average of 8 weeks ] [ Designated as safety issue: No ]
    Assesses mood in terms of number of depressive symptoms


Estimated Enrollment: 75
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBT group
mentalization based treatment program
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.
Other Name: Psychotherapeutic program
Active Comparator: Treatment as usual group
treatment as usual group
Other: treatment as usual
less intensive and structured psychotherapeutic program
Other Name: Psychotherapeutic program

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204346

Contacts
Contact: trudie I Rossouw, Dr +448446001200 trudie.rossouw@nelft.nhs.uk

Locations
United Kingdom
North East London Foundation Trust Recruiting
Ilford, Essex, United Kingdom, IG3 8XQ
Contact: trudie i rossouw, dr    +448446001200      
Principal Investigator: trudie i rossouw, dr         
Sponsors and Collaborators
North East London Foundation Trust
Investigators
Principal Investigator: trudie i rossouw, dr North East London Foundation Trust
  More Information

Additional Information:
Publications:
Responsible Party: Dr T Rossouw, North East London Foundation Trust
ClinicalTrials.gov Identifier: NCT01204346     History of Changes
Other Study ID Numbers: TRossouw
Study First Received: September 16, 2010
Last Updated: July 21, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by North East London Foundation Trust:
adolescents
MBT
depression
emerging personality disorder

Additional relevant MeSH terms:
Personality Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014