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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Psychiatric Research Unit, Region Zealand, Denmark
Sponsor:
Information provided by (Responsible Party):
Psychiatric Research Unit, Region Zealand, Denmark
ClinicalTrials.gov Identifier:
NCT02068326
First received: February 19, 2014
Last updated: October 6, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Behavioral: Mentalization Based Treatment
Behavioral: Treatment As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Psychiatric Research Unit, Region Zealand, Denmark:

Primary Outcome Measures:
  • The Borderline Personality Feature Scale for Children (BPFS-C) [ Time Frame: Change from Baseline in BPFS-C at 40 weeks ] [ Designated as safety issue: No ]
  • The Borderline Personality Feature Scale for Children (BPFS-C) [ Time Frame: Change from Baseline in BPFS-C at 10 weeks ] [ Designated as safety issue: No ]
  • The Borderline Personality Feature Scale for Children (BPFS-C) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
  • The Borderline Personality Feature Scale for Children (BPFS-C) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Becks Depression Inventory for Youth [ Time Frame: Change from Baseline in at 10 weeks ] [ Designated as safety issue: No ]
  • Becks Depression Inventory for Youth [ Time Frame: Change from Baseline in at 20 weeks ] [ Designated as safety issue: No ]
  • Becks Depression Inventory for Youth [ Time Frame: Change from Baseline in at 30 weeks ] [ Designated as safety issue: No ]
  • Becks Depression Inventory for Youth [ Time Frame: Change from Baseline in at 40 weeks ] [ Designated as safety issue: No ]
  • The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA) [ Time Frame: change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA) [ Time Frame: change from baseline at 20 weeks ] [ Designated as safety issue: No ]
  • The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA) [ Time Frame: Chage from baseline at 30 weeks ] [ Designated as safety issue: No ]
  • ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The Childrens' Global Assessment Scale (CGAS) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The childhood behaviour checklist (CBCL, Parental outcome measure) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The childhood behaviour checklist (CBCL, Parental outcome measure) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • The childhood behaviour checklist (CBCL, Parental outcome measure) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
  • The childhood behaviour checklist (CBCL, Parental outcome measure) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
  • The borderline personality feature scale for Children - parental version (BPFS-P) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The borderline personality feature scale for Children - parental version (BPFS-P) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • The borderline personality feature scale for Children - parental version (BPFS-P) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
  • The borderline personality feature scale for Children - parental version (BPFS-P) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
  • Number of patients' hospital admissions and visits to the emergency room [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
  • The Youth Self-Report (YSR) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
  • The Youth Self-Report (YSR) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
  • The Youth Self-Report (YSR) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
  • The Youth Self-Report (YSR) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Experience of Close Relationships Inventory (ECR) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Experience of Close Relationships Inventory (ECR) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Experience of Close Relationships Inventory (ECR) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Experience of Close Relationships Inventory (ECR) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Inventory of Parent and Peer Attachment - Revised (IPPA-R) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Inventory of Parent and Peer Attachment - Revised (IPPA-R) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Inventory of Parent and Peer Attachment - Revised (IPPA-R) [ Time Frame: Change from baseline at 20 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Inventory of Parent and Peer Attachment - Revised (IPPA-R) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Reflective Function Questionnaire for Youth (RFQ-Y) [ Time Frame: Change from baseline at 40 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Reflective Function Questionnaire for Youth (RFQ-Y) [ Time Frame: Change from baseline at 10 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Reflective Function Questionnaire for Youth (RFQ-Y) [ Time Frame: Change from baseline 20 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)

  • Reflective Function Questionnaire for Youth (RFQ-Y) [ Time Frame: Change from baseline at 30 weeks ] [ Designated as safety issue: No ]
    Treatment related variable (mediator)


Estimated Enrollment: 112
Study Start Date: September 2015
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Behavioral: Mentalization Based Treatment
Other Name: MBT
Active Comparator: 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.
Behavioral: Treatment As Usual
Treatment As Usual

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02068326

Contacts
Contact: Emma Beck, MSc +45 47 32 77 75 emma.beck@regionsjaelland.dk
Contact: Erik Simonsen, PhD +45 20108293 es@regionsjaelland.dk

Locations
Denmark
Child and Adolescent Psychiatric Department, Region Zealand Recruiting
Roskilde, Region Zealand, Denmark, 4000
Sponsors and Collaborators
Psychiatric Research Unit, Region Zealand, Denmark
Investigators
Principal Investigator: Erik Simonsen, PhD Psychiatric Research Unit, Region Zealand, Denmark
  More Information

Responsible Party: Psychiatric Research Unit, Region Zealand, Denmark
ClinicalTrials.gov Identifier: NCT02068326     History of Changes
Other Study ID Numbers: SJ-371 
Study First Received: February 19, 2014
Last Updated: October 6, 2015
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Psychiatric Research Unit, Region Zealand, Denmark:
Mentalization-based Treatment
Adolescence
Borderline Personality Disorder

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2016