Borderline Personality DisorderM-GABNCT02068326
MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
A study testing Mentalization Based Treatment and Treatment As Usual in people with Borderline Personality Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Mentalization Based Treatment and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 11 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Child and Adolescent Psychiatric Department, Region Zealand
Roskilde, Region Sjælland, 4000
About this study
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
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.
Read more
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
- Being tested
- Mentalization Based Treatment, Treatment As Usual
- Keywords
- Mentalization-based Treatment, Adolescence, Borderline Personality Disorder
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization Based TreatmentBehavioural
Also called MBT
Treatment As UsualBehavioural
Treatment As Usual
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Borderline Personality Feature Scale for Children (BPFS-C)
Measured: Change from Baseline in BPFS-C at 40 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Measured: Change from Baseline in BPFS-C at 10 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Measured: Change from baseline at 20 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Measured: Change from baseline at 30 weeks
Secondary outcomes (24)
Becks Depression Inventory for Youth
Measured: Change from Baseline in at 10 weeks
Becks Depression Inventory for Youth
Measured: Change from Baseline in at 20 weeks
Becks Depression Inventory for Youth
Measured: Change from Baseline in at 30 weeks
Becks Depression Inventory for Youth
Measured: Change from Baseline in at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Measured: Change from baseline at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Measured: change from baseline at 10 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Measured: change from baseline at 20 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Measured: Chage from baseline at 30 weeks
ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder
Measured: Change from baseline at 40 weeks
The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)
Measured: Change from baseline at 40 weeks
The Childrens' Global Assessment Scale (CGAS)
Measured: Change from baseline at 40 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Measured: Change from baseline at 40 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Measured: Change from baseline at 10 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Measured: Change from baseline at 20 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Measured: Change from baseline at 30 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Measured: Change from baseline at 40 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Measured: Change from baseline at 10 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Measured: Change from baseline at 20 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Measured: Change from baseline at 30 weeks
Number of patients' hospital admissions and visits to the emergency room
Measured: Change from baseline at 40 weeks
The Youth Self-Report (YSR)
Measured: Change from baseline at 10 weeks
The Youth Self-Report (YSR)
Measured: Change from baseline at 20 weeks
The Youth Self-Report (YSR)
Measured: Change from baseline at 30 weeks
The Youth Self-Report (YSR)
Measured: Change from baseline at 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startSep 2015
- Primary completion11 May 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Simonsen, PhD, Principal investigator, Psychiatric Research Unit, Region Zealand, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068326
- Sponsor's protocol ID
- SJ-371
- Acronym
- M-GAB
- Status last verified
- Jun 2020
- First submitted
- 19 Feb 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32388627Storebo 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.
PubMed 32368793Beck 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.
PubMed 31702058Beck 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.
PubMed 27405522
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02068326
- Acronym / sponsor ID
- M-GAB / SJ-371
- Conditions
- Borderline Personality Disorder
- Keywords
- Mentalization-based Treatment, Adolescence, Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalization Based Treatment | Experimental | Behavioral: Mentalization Based Treatmentthe 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). |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualParticipants 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization Based TreatmentAlso: MBT | Behavioural | Mentalization Based Treatment |
| Treatment As UsualTreatment As Usual | Behavioural | Treatment As Usual |
Primary outcome
The Borderline Personality Feature Scale for Children (BPFS-C)
Time frame: Change from Baseline in BPFS-C at 40 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Time frame: Change from Baseline in BPFS-C at 10 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Time frame: Change from baseline at 20 weeks
The Borderline Personality Feature Scale for Children (BPFS-C)
Time frame: Change from baseline at 30 weeks
24 secondary outcomes
Becks Depression Inventory for Youth
Time frame: Change from Baseline in at 10 weeks
Becks Depression Inventory for Youth
Time frame: Change from Baseline in at 20 weeks
Becks Depression Inventory for Youth
Time frame: Change from Baseline in at 30 weeks
Becks Depression Inventory for Youth
Time frame: Change from Baseline in at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Time frame: Change from baseline at 40 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Time frame: change from baseline at 10 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Time frame: change from baseline at 20 weeks
The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)
Time frame: Chage from baseline at 30 weeks
ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder
Time frame: Change from baseline at 40 weeks
The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)
Time frame: Change from baseline at 40 weeks
The Childrens' Global Assessment Scale (CGAS)
Time frame: Change from baseline at 40 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Time frame: Change from baseline at 40 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Time frame: Change from baseline at 10 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Time frame: Change from baseline at 20 weeks
The childhood behaviour checklist (CBCL, Parental outcome measure)
Time frame: Change from baseline at 30 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Time frame: Change from baseline at 40 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Time frame: Change from baseline at 10 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Time frame: Change from baseline at 20 weeks
The borderline personality feature scale for Children - parental version (BPFS-P)
Time frame: Change from baseline at 30 weeks
Number of patients' hospital admissions and visits to the emergency room
Time frame: Change from baseline at 40 weeks
The Youth Self-Report (YSR)
Time frame: Change from baseline at 10 weeks
The Youth Self-Report (YSR)
Time frame: Change from baseline at 20 weeks
The Youth Self-Report (YSR)
Time frame: Change from baseline at 30 weeks
The Youth Self-Report (YSR)
Time frame: Change from baseline at 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 32388627Jorgensen 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.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 31702058Beck 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.
- Derived from this study: PubMed 27405522Beck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Simonsen, PhD principal investigator
Psychiatric Research Unit, Region Zealand, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization Based Treatment and Treatment As Usual in people with Borderline Personality Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Borderline Personality Feature Scale for Children (BPFS-C) (time frame: Change from Baseline in BPFS-C at 40 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068326, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.