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MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial

Mentalization-Based Treatment in Groups for Adolescents With Borderline Personality Disorder (BPD) or Subthreshold BPD Versus Treatment As Usual - the M-GAB Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02068326
Acronym
M-GAB
Enrollment
112
Registered
2014-02-21
Start date
2015-09-30
Completion date
2019-04-11
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

Mentalization-based Treatment, Adolescence, Borderline Personality Disorder

Brief summary

Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in adolescents younger than 18 years according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly shown to be effective in treating adult BPD, but in the case of adolescents, only individual MBT have been tested and found to be effective. 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.

Interventions

BEHAVIORALMentalization Based Treatment
BEHAVIORALTreatment As Usual

Treatment As Usual

Sponsors

Psychiatric Research Unit, Region Zealand, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Meet a minimum of 4 DSM-5 BPD criteria * Have parent's or parent substitute's commitment and ability to participate in the MBT-Parents program. * Score 67\< BPFS-C

Exclusion criteria

* Comorbid diagnosis of pervasive developmental disorder, learning disability (75 \< IQ), anorexia, current psychosis, diagnosis of schizophrenia or schizotypal personality disorder, antisocial personality disorder as well as any other axis-I or axis-II psychopathology considered to be the primary diagnosis. * 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

Design outcomes

Primary

MeasureTime frame
The Borderline Personality Feature Scale for Children (BPFS-C)Change from Baseline in BPFS-C at 40 weeks

Secondary

MeasureTime frame
The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)Change from baseline at 40 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)Change from baseline at 40 weeks
Number of patients' hospital admissions and visits to the emergency roomChange from baseline at 40 weeks
The Youth Self-Report (YSR)Change from baseline at 10 weeks
Becks Depression Inventory for YouthChange from Baseline in at 10 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)Change from baseline at 40 weeks
ZAN-BPD Zanarini Rating Scale for Borderline Personality DisorderChange from baseline at 40 weeks
The Childrens' Global Assessment Scale (CGAS)Change from baseline at 40 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)Change from baseline at 40 weeks

Other

MeasureTime frameDescription
Reflective Function Questionnaire for Youth (RFQ-Y)Change from baseline at 40 weeksTreatment related variable (mediator)
Inventory of Parent and Peer Attachment - Revised (IPPA-R)Change from baseline at 40 weeksTreatment related variable (mediator)
Experience of Close Relationships Inventory (ECR)Change from baseline at 40 weeksTreatment related variable (mediator)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026