MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
NCT ID: NCT02068326
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2015-09-30
2019-04-11
Brief Summary
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Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As Usual (TAU) in treating adolescents with BPD or subthreshold BPD.
Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up will be at three and 12 months.
Discussion: Early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. In addition to being cost effective, using the group modality in the treatment of BPD may have several advantages. This is the first Randomized Controlled Trial (RCT) to test the effectiveness of MBT in groups for adolescents.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mentalization Based Treatment
the experimental intervention is a year-long manualized program that comprises four components:
* Five individual case-formulation sessions,
* MBT-I, an introductory pedagogical program for patients (three weekly sessions)
* MBT-G, MBT-program in groups (37 weekly sessions)
* MBT-P, a psychoeducation program for the patients' parents or parents substitutes (six sessions).
Mentalization Based Treatment
Treatment As Usual
Participants randomized to the control group will receive Treatment As Usual (TAU). TAU is defined as comprising at least 12 monthly individual supportive sessions provided by non-MBT trained mental health professionals in the Department of Child and Adolescent Psychiatry in Region Zealand. Additional supportive sessions or other types of intervention may be offered to the patients according to the needs of the patients as evaluated by mental health professionals responsible for his/hers treatment. Hence, TAU may vary considerably in number and type of intervention across clinics and patients. All mental health services delivered during the treatment period to patients in the TAU group will be monitored and registered.
Treatment As Usual
Treatment As Usual
Interventions
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Mentalization Based Treatment
Treatment As Usual
Treatment As Usual
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have parent's or parent substitute's commitment and ability to participate in the MBT-Parents program.
* Score 67\< BPFS-C
Exclusion Criteria
* Current psychiatric inpatient treatment
* Current (past two months) substance dependence (but not substance misuse)
* Participation in concurrent psychotherapeutic treatment outside the MBT program
* Not able to speak Danish
* Lack of informed consent
14 Years
17 Years
ALL
No
Sponsors
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Psychiatric Research Unit, Region Zealand, Denmark
OTHER
Responsible Party
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Principal Investigators
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Erik Simonsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Research Unit, Region Zealand, Denmark
Locations
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Child and Adolescent Psychiatric Department, Region Zealand
Roskilde, Region Sjælland, Denmark
Countries
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References
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Jorgensen MS, Storebo OJ, Bo S, Poulsen S, Gondan M, Beck E, Chanen AM, Bateman A, Pedersen J, Simonsen E. Mentalization-based treatment in groups for adolescents with Borderline Personality Disorder: 3- and 12-month follow-up of a randomized controlled trial. Eur Child Adolesc Psychiatry. 2021 May;30(5):699-710. doi: 10.1007/s00787-020-01551-2. Epub 2020 May 9.
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Beck E, Bo S, Jorgensen MS, Gondan M, Poulsen S, Storebo OJ, Fjellerad Andersen C, Folmo E, Sharp C, Pedersen J, Simonsen E. Mentalization-based treatment in groups for adolescents with borderline personality disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2020 May;61(5):594-604. doi: 10.1111/jcpp.13152. Epub 2019 Nov 8.
Beck E, Bo S, Gondan M, Poulsen S, Pedersen L, Pedersen J, Simonsen E. Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial. Trials. 2016 Jul 12;17(1):314. doi: 10.1186/s13063-016-1431-0.
Other Identifiers
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SJ-371
Identifier Type: -
Identifier Source: org_study_id
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