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

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

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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Mentalization Based Treatment; Behavioral: Treatment As Usual

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Zealand
    • Roskilde, Region Zealand, Denmark, 4000
      • Child and Adolescent Psychiatric Department, Region Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Borderline Personality Feature Scale for Children (BPFS-C)	Change from Baseline in BPFS-C at 40 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)	Change from Baseline in BPFS-C at 10 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)	Change from baseline at 20 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)	Change from baseline at 30 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Becks Depression Inventory for Youth	Change from Baseline in at 10 weeks
Becks Depression Inventory for Youth	Change from Baseline in at 20 weeks
Becks Depression Inventory for Youth	Change from Baseline in at 30 weeks
Becks Depression Inventory for Youth	Change from Baseline in at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)	Change from baseline at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)	change from baseline at 10 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)	change from baseline at 20 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)	Chage from baseline at 30 weeks
ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder	Change from baseline at 40 weeks
The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)	Change 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
The childhood behaviour checklist (CBCL, Parental outcome measure)	Change from baseline at 10 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)	Change from baseline at 20 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)	Change from baseline at 30 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)	Change from baseline at 40 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)	Change from baseline at 10 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)	Change from baseline at 20 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)	Change from baseline at 30 weeks
Number of patients' hospital admissions and visits to the emergency room	Change from baseline at 40 weeks
The Youth Self-Report (YSR)	Change from baseline at 10 weeks
The Youth Self-Report (YSR)	Change from baseline at 20 weeks
The Youth Self-Report (YSR)	Change from baseline at 30 weeks
The Youth Self-Report (YSR)	Change from baseline at 40 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 20 weeks
Experience of Close Relationships Inventory (ECR)	Treatment related variable (mediator)	Change from baseline at 30 weeks
Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 20 weeks
Inventory of Parent and Peer Attachment - Revised (IPPA-R)	Treatment related variable (mediator)	Change from baseline at 30 weeks
Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 40 weeks
Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 10 weeks
Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline 20 weeks
Reflective Function Questionnaire for Youth (RFQ-Y)	Treatment related variable (mediator)	Change from baseline at 30 weeks

Collaborators and Investigators

• Sponsor: Psychiatric Research Unit, Region Zealand, Denmark
• Investigators: Principal Investigator: Erik Simonsen, PhD, Psychiatric Research Unit, Region Zealand, Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• Beck E, Bo S, Jørgensen MS, Gondan M, Poulsen S, Storebø 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 11, 2018
• Study Completion (Actual): April 11, 2019

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Borderline Personality Disorder; Adolescence; Mentalization-based Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: SJ-371