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

Borderline Personality Disorder Clinical Trial

— M-GAB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068326
• Other study ID #: SJ-371
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 11, 2019

Study information

• Verified date: June 2020
• Source: Psychiatric Research Unit, Region Zealand, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 11, 2019
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Mentalization Based Treatment

• Treatment As Usual
Treatment As Usual

Locations

Country	Name	City	State
Denmark	Child and Adolescent Psychiatric Department, Region Zealand	Roskilde	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric Research Unit, Region Zealand, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Other	Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Other	Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 20 weeks
Other	Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 30 weeks
Other	Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Other	Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Other	Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 20 weeks
Other	Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 30 weeks
Other	Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Other	Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Other	Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline 20 weeks
Other	Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 30 weeks
Primary	The Borderline Personality Feature Scale for Children (BPFS-C)		Change from Baseline in BPFS-C at 40 weeks
Primary	The Borderline Personality Feature Scale for Children (BPFS-C)		Change from Baseline in BPFS-C at 10 weeks
Primary	The Borderline Personality Feature Scale for Children (BPFS-C)		Change from baseline at 20 weeks
Primary	The Borderline Personality Feature Scale for Children (BPFS-C)		Change from baseline at 30 weeks
Secondary	Becks Depression Inventory for Youth		Change from Baseline in at 10 weeks
Secondary	Becks Depression Inventory for Youth		Change from Baseline in at 20 weeks
Secondary	Becks Depression Inventory for Youth		Change from Baseline in at 30 weeks
Secondary	Becks Depression Inventory for Youth		Change from Baseline in at 40 weeks
Secondary	The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)		Change from baseline at 40 weeks
Secondary	The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)		change from baseline at 10 weeks
Secondary	The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)		change from baseline at 20 weeks
Secondary	The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)		Chage from baseline at 30 weeks
Secondary	ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder		Change from baseline at 40 weeks
Secondary	The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)		Change from baseline at 40 weeks
Secondary	The Childrens' Global Assessment Scale (CGAS)		Change from baseline at 40 weeks
Secondary	The childhood behaviour checklist (CBCL, Parental outcome measure)		Change from baseline at 40 weeks
Secondary	The childhood behaviour checklist (CBCL, Parental outcome measure)		Change from baseline at 10 weeks
Secondary	The childhood behaviour checklist (CBCL, Parental outcome measure)		Change from baseline at 20 weeks
Secondary	The childhood behaviour checklist (CBCL, Parental outcome measure)		Change from baseline at 30 weeks
Secondary	The borderline personality feature scale for Children - parental version (BPFS-P)		Change from baseline at 40 weeks
Secondary	The borderline personality feature scale for Children - parental version (BPFS-P)		Change from baseline at 10 weeks
Secondary	The borderline personality feature scale for Children - parental version (BPFS-P)		Change from baseline at 20 weeks
Secondary	The borderline personality feature scale for Children - parental version (BPFS-P)		Change from baseline at 30 weeks
Secondary	Number of patients' hospital admissions and visits to the emergency room		Change from baseline at 40 weeks
Secondary	The Youth Self-Report (YSR)		Change from baseline at 10 weeks
Secondary	The Youth Self-Report (YSR)		Change from baseline at 20 weeks
Secondary	The Youth Self-Report (YSR)		Change from baseline at 30 weeks
Secondary	The Youth Self-Report (YSR)		Change from baseline at 40 weeks