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Completed

NCT Number: NCT02068326

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

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Psychiatric Department, Region Zealand

Roskilde, Region Sjælland, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentalization Based Treatment

Behavioral

Other names: MBT

Treatment as Usual

Behavioral

Treatment As Usual

Primary outcomes

  1. The Borderline Personality Feature Scale for Children (BPFS-C)

    Time frame: Change from Baseline in BPFS-C at 40 weeks

  2. The Borderline Personality Feature Scale for Children (BPFS-C)

    Time frame: Change from Baseline in BPFS-C at 10 weeks

  3. The Borderline Personality Feature Scale for Children (BPFS-C)

    Time frame: Change from baseline at 20 weeks

  4. The Borderline Personality Feature Scale for Children (BPFS-C)

    Time frame: Change from baseline at 30 weeks

Secondary outcomes

  1. Becks Depression Inventory for Youth

    Time frame: Change from Baseline in at 10 weeks

  2. Becks Depression Inventory for Youth

    Time frame: Change from Baseline in at 20 weeks

  3. Becks Depression Inventory for Youth

    Time frame: Change from Baseline in at 30 weeks

  4. Becks Depression Inventory for Youth

    Time frame: Change from Baseline in at 40 weeks

  5. The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)

    Time frame: Change from baseline at 40 weeks

  6. The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)

    Time frame: change from baseline at 10 weeks

  7. The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)

    Time frame: change from baseline at 20 weeks

  8. The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)

    Time frame: Chage from baseline at 30 weeks

  9. ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder

    Time frame: Change from baseline at 40 weeks

  10. The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)

    Time frame: Change from baseline at 40 weeks

  11. The Childrens' Global Assessment Scale (CGAS)

    Time frame: Change from baseline at 40 weeks

  12. The childhood behaviour checklist (CBCL, Parental outcome measure)

    Time frame: Change from baseline at 40 weeks

  13. The childhood behaviour checklist (CBCL, Parental outcome measure)

    Time frame: Change from baseline at 10 weeks

  14. The childhood behaviour checklist (CBCL, Parental outcome measure)

    Time frame: Change from baseline at 20 weeks

  15. The childhood behaviour checklist (CBCL, Parental outcome measure)

    Time frame: Change from baseline at 30 weeks

  16. The borderline personality feature scale for Children - parental version (BPFS-P)

    Time frame: Change from baseline at 40 weeks

  17. The borderline personality feature scale for Children - parental version (BPFS-P)

    Time frame: Change from baseline at 10 weeks

  18. The borderline personality feature scale for Children - parental version (BPFS-P)

    Time frame: Change from baseline at 20 weeks

  19. The borderline personality feature scale for Children - parental version (BPFS-P)

    Time frame: Change from baseline at 30 weeks

  20. Number of patients' hospital admissions and visits to the emergency room

    Time frame: Change from baseline at 40 weeks

  21. The Youth Self-Report (YSR)

    Time frame: Change from baseline at 10 weeks

  22. The Youth Self-Report (YSR)

    Time frame: Change from baseline at 20 weeks

  23. The Youth Self-Report (YSR)

    Time frame: Change from baseline at 30 weeks

  24. The Youth Self-Report (YSR)

    Time frame: Change from baseline at 40 weeks

Other outcomes

  1. Experience of Close Relationships Inventory (ECR)

    Time frame: Change from baseline at 40 weeks

    Treatment related variable (mediator)

  2. Experience of Close Relationships Inventory (ECR)

    Time frame: Change from baseline at 10 weeks

    Treatment related variable (mediator)

  3. Experience of Close Relationships Inventory (ECR)

    Time frame: Change from baseline at 20 weeks

    Treatment related variable (mediator)

  4. Experience of Close Relationships Inventory (ECR)

    Time frame: Change from baseline at 30 weeks

    Treatment related variable (mediator)

  5. Inventory of Parent and Peer Attachment - Revised (IPPA-R)

    Time frame: Change from baseline at 40 weeks

    Treatment related variable (mediator)

  6. Inventory of Parent and Peer Attachment - Revised (IPPA-R)

    Time frame: Change from baseline at 10 weeks

    Treatment related variable (mediator)

  7. Inventory of Parent and Peer Attachment - Revised (IPPA-R)

    Time frame: Change from baseline at 20 weeks

    Treatment related variable (mediator)

  8. Inventory of Parent and Peer Attachment - Revised (IPPA-R)

    Time frame: Change from baseline at 30 weeks

    Treatment related variable (mediator)

  9. Reflective Function Questionnaire for Youth (RFQ-Y)

    Time frame: Change from baseline at 40 weeks

    Treatment related variable (mediator)

  10. Reflective Function Questionnaire for Youth (RFQ-Y)

    Time frame: Change from baseline at 10 weeks

    Treatment related variable (mediator)

  11. Reflective Function Questionnaire for Youth (RFQ-Y)

    Time frame: Change from baseline 20 weeks

    Treatment related variable (mediator)

  12. Reflective Function Questionnaire for Youth (RFQ-Y)

    Time frame: Change from baseline at 30 weeks

    Treatment related variable (mediator)

Sponsors and collaborators

Lead sponsor

Psychiatric Research Unit, Region Zealand, Denmark

Other

Registry information

Official study title

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

Acronym: M-GAB

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Feb 21, 2014
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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