search
Back to results

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

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mentalization Based Treatment
Treatment As Usual
Sponsored by
Psychiatric Research Unit, Region Zealand, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Mentalization-based Treatment, Adolescence, Borderline Personality Disorder

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Child and Adolescent Psychiatric Department, Region Zealand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mentalization Based Treatment

Treatment As Usual

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Becks Depression Inventory for Youth
Becks Depression Inventory for Youth
Becks Depression Inventory for Youth
Becks Depression Inventory for Youth
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder
The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)
The Childrens' Global Assessment Scale (CGAS)
The childhood behaviour checklist (CBCL, Parental outcome measure)
The childhood behaviour checklist (CBCL, Parental outcome measure)
The childhood behaviour checklist (CBCL, Parental outcome measure)
The childhood behaviour checklist (CBCL, Parental outcome measure)
The borderline personality feature scale for Children - parental version (BPFS-P)
The borderline personality feature scale for Children - parental version (BPFS-P)
The borderline personality feature scale for Children - parental version (BPFS-P)
The borderline personality feature scale for Children - parental version (BPFS-P)
Number of patients' hospital admissions and visits to the emergency room
The Youth Self-Report (YSR)
The Youth Self-Report (YSR)
The Youth Self-Report (YSR)
The Youth Self-Report (YSR)

Full Information

First Posted
February 19, 2014
Last Updated
June 10, 2020
Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT02068326
Brief Title
MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psychiatric Research Unit, Region Zealand, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Mentalization-based Treatment, Adolescence, Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Simonsen, PhD
Organizational Affiliation
Psychiatric Research Unit, Region Zealand, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatric Department, Region Zealand
City
Roskilde
State/Province
Region Zealand
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32388627
Citation
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.
Results Reference
derived
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
PubMed Identifier
31702058
Citation
Beck E, Bo S, Jorgensen MS, Gondan M, Poulsen S, Storebo 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.
Results Reference
derived
PubMed Identifier
27405522
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs