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

NCT02068326 | Completed DMC

• 1 other identifier: SJ-371
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Mentalization-based Treatment; Adolescence; Borderline Personality Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• 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

Other Outcomes (12)

• Experience of Close Relationships Inventory (ECR)

  Change from baseline at 40 weeks

• Experience of Close Relationships Inventory (ECR)

  Change from baseline at 10 weeks

• Experience of Close Relationships Inventory (ECR)

  Change from baseline at 20 weeks

Study Arms (2)

Mentalization Based Treatment

EXPERIMENTAL

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

Treatment As Usual

ACTIVE COMPARATOR

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

Interventions

Mentalization Based Treatment BEHAVIORAL

Also known as: MBT

Mentalization Based Treatment

Treatment As Usual BEHAVIORAL

Treatment As Usual

Treatment As Usual

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead

Study Sites (1)

Child and Adolescent Psychiatric Department, Region Zealand

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (4)

• 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.

  PMID: 32388627 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 31702058 DERIVED

• 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.

  PMID: 27405522 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Mentalization-Based Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Erik Simonsen, PhD

  Psychiatric Research Unit, Region Zealand, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: September 1, 2015
• Primary Completion: May 11, 2018
• Study Completion: April 11, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

DK (1)