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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Mentalization Based Treatment
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentalization Based Treatment<br>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<br> <br> * Other names: MBT;|
| Active Comparator: Treatment As Usual<br>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<br>* Treatment As Usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mentalization-based Treatment, Adolescence, Borderline Personality Disorder