Clinical trial NCT02068326: MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Mentalization-based Treatment
Adolescence
Borderline Personality Disorder
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 112
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Borderline Personality Feature Scale for Children (BPFS-C)
timeFrame: Change from Baseline in BPFS-C at 40 weeks
measure: The Borderline Personality Feature Scale for Children (BPFS-C)
timeFrame: Change from Baseline in BPFS-C at 10 weeks
measure: The Borderline Personality Feature Scale for Children (BPFS-C)
timeFrame: Change from baseline at 20 weeks
measure: The Borderline Personality Feature Scale for Children (BPFS-C)
timeFrame: Change from baseline at 30 weeks
Secondary outcomes:
measure: Becks Depression Inventory for Youth
timeFrame: Change from Baseline in at 10 weeks
measure: Becks Depression Inventory for Youth
timeFrame: Change from Baseline in at 20 weeks
measure: Becks Depression Inventory for Youth
timeFrame: Change from Baseline in at 30 weeks
measure: Becks Depression Inventory for Youth
timeFrame: Change from Baseline in at 40 weeks
measure: The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
timeFrame: Change from baseline at 40 weeks
measure: The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
timeFrame: change from baseline at 10 weeks
measure: The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
timeFrame: change from baseline at 20 weeks
measure: The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
timeFrame: Chage from baseline at 30 weeks
measure: ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder
timeFrame: Change from baseline at 40 weeks
measure: The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)
timeFrame: Change from baseline at 40 weeks
measure: The Childrens' Global Assessment Scale (CGAS)
timeFrame: Change from baseline at 40 weeks
measure: The childhood behaviour checklist (CBCL, Parental outcome measure)
timeFrame: Change from baseline at 40 weeks
measure: The childhood behaviour checklist (CBCL, Parental outcome measure)
timeFrame: Change from baseline at 10 weeks
measure: The childhood behaviour checklist (CBCL, Parental outcome measure)
timeFrame: Change from baseline at 20 weeks
measure: The childhood behaviour checklist (CBCL, Parental outcome measure)
timeFrame: Change from baseline at 30 weeks
measure: The borderline personality feature scale for Children - parental version (BPFS-P)
timeFrame: Change from baseline at 40 weeks
measure: The borderline personality feature scale for Children - parental version (BPFS-P)
timeFrame: Change from baseline at 10 weeks
measure: The borderline personality feature scale for Children - parental version (BPFS-P)
timeFrame: Change from baseline at 20 weeks
measure: The borderline personality feature scale for Children - parental version (BPFS-P)
timeFrame: Change from baseline at 30 weeks
measure: Number of patients' hospital admissions and visits to the emergency room
timeFrame: Change from baseline at 40 weeks
measure: The Youth Self-Report (YSR)
timeFrame: Change from baseline at 10 weeks
measure: The Youth Self-Report (YSR)
timeFrame: Change from baseline at 20 weeks
measure: The Youth Self-Report (YSR)
timeFrame: Change from baseline at 30 weeks
measure: The Youth Self-Report (YSR)
timeFrame: Change from baseline at 40 weeks
Other outcomes:
measure: Experience of Close Relationships Inventory (ECR)
timeFrame: Change from baseline at 40 weeks
measure: Experience of Close Relationships Inventory (ECR)
timeFrame: Change from baseline at 10 weeks
measure: Experience of Close Relationships Inventory (ECR)
timeFrame: Change from baseline at 20 weeks
measure: Experience of Close Relationships Inventory (ECR)
timeFrame: Change from baseline at 30 weeks
measure: Inventory of Parent and Peer Attachment - Revised (IPPA-R)
timeFrame: Change from baseline at 40 weeks
measure: Inventory of Parent and Peer Attachment - Revised (IPPA-R)
timeFrame: Change from baseline at 10 weeks
measure: Inventory of Parent and Peer Attachment - Revised (IPPA-R)
timeFrame: Change from baseline at 20 weeks
measure: Inventory of Parent and Peer Attachment - Revised (IPPA-R)
timeFrame: Change from baseline at 30 weeks
measure: Reflective Function Questionnaire for Youth (RFQ-Y)
timeFrame: Change from baseline at 40 weeks
measure: Reflective Function Questionnaire for Youth (RFQ-Y)
timeFrame: Change from baseline at 10 weeks
measure: Reflective Function Questionnaire for Youth (RFQ-Y)
timeFrame: Change from baseline 20 weeks
measure: Reflective Function Questionnaire for Youth (RFQ-Y)
timeFrame: Change from baseline at 30 weeks
Locations:
city: Roskilde
country: Denmark
facility: Child and Adolescent Psychiatric Department, Region Zealand
state: Region Zealand
Study officials:
affiliation: Psychiatric Research Unit, Region Zealand, Denmark
name: Erik Simonsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.