DepressionMBTNCT01204346
Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality Disorder
A study testing MBT and treatment as usual in people with Depression and Personality Disorder, run by North East London Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression, Personality Disorder
- What is being tested?
- MBT and treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Young people with autistic spectrum disorders or severe learning disabilities.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
North East London Foundation Trust
Ilford, Essex, IG3 8XQ
trudie i rossouw, dr, +448446001200
trudie i rossouw, dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Personality Disorder
- Being tested
- MBT, treatment as usual
- Keywords
- adolescents, MBT, depression, emerging personality disorder
- Medical subject headings
- Depression, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBTOther
Also called Psychotherapeutic 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.
treatment as usualOther
Also called Psychotherapeutic program
less intensive and structured psychotherapeutic program
| Study group | Role | What they receive |
|---|---|---|
| MBT group | Experimental | mentalization based treatment program Receives: Other: MBT |
| Treatment as usual group | Active comparator | treatment as usual group Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global assessment of functioning
Measures global functioning
Measured: 2 years post discharge
Global assessment of functioning
measures level of functioning
Measured: within 1 week of admission
global assessment of functioning
measures level of functioning
Measured: Average of 8 weeks
Secondary outcomes (3)
mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms
Measured: 2 years post discharge
Mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms
Measured: Within 1 week of admission
mood and feelings questionnaire
Assesses mood in terms of number of depressive symptoms
Measured: At average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North East London Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trudie Rossouw, North East London Foundation Trust
- Investigators
- trudie i rossouw, dr, Principal investigator, North East London Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204346
- Sponsor's protocol ID
- TRossouw
- Acronym
- MBT
- Status last verified
- Jul 2011
- First submitted
- 16 Sep 2010
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20148147Bateman 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.
PubMed 19833787Crawford 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.
PubMed 18519822Kasen 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.
PubMed 10518162Kasen 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.
PubMed 17201867Lewinsohn 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.
PubMed 9893417Chanen 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.
PubMed 17908019
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentalization - Based Treatment for Young People Presenting With Co-morbid Depression and Symptoms of Emerging Personality Disorder: Prospective Controlled Trial.
- ClinicalTrials.gov ID
- NCT01204346
- Acronym / sponsor ID
- MBT / TRossouw
- Conditions
- Depression, Personality Disorder
- Keywords
- adolescents, MBT, depression, emerging personality disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- North East London Foundation TrustUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBT group | Experimental | Other: MBTmentalization based treatment program |
| Treatment as usual group | Active comparator | Other: treatment as usualtreatment as usual group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Young people with autistic spectrum disorders or severe learning disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBTAlso: Psychotherapeutic programThe 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 | MBT group |
| treatment as usualAlso: Psychotherapeutic programless intensive and structured psychotherapeutic program | Other | Treatment as usual group |
Primary outcome
Global assessment of functioning
Time frame: 2 years post discharge
Measures global functioning
Global assessment of functioning
Time frame: within 1 week of admission
measures level of functioning
global assessment of functioning
Time frame: Average of 8 weeks
measures level of functioning
3 secondary outcomes
mood and feelings questionnaire
Time frame: 2 years post discharge
Mood and feelings questionnaire
Time frame: Within 1 week of admission
mood and feelings questionnaire
Time frame: At average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Background: PubMed 20148147Bateman 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.
- Background: PubMed 19833787Bateman 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.
- Background: PubMed 18519822Crawford 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.
- Background: PubMed 10518162Kasen 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.
- Background: PubMed 17201867Kasen 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.
- Background: PubMed 9893417Lewinsohn 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.
- Background: PubMed 17908019Chanen 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.
- host NHS organisationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
trudie i rossouw, dr principal investigator
North East London Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBT and treatment as usual in people with Depression and Personality Disorder, run by North East London Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact trudie I Rossouw, Dr (+448446001200, trudie.rossouw@nelft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global assessment of functioning (time frame: 2 years post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01204346, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.