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Borderline Personality DisorderMAGNETNCT06018272

Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany

A study testing Mentalization-Based Treatment (MBT) and Bona-Fide Treatment in Germany (BFT) in people with Borderline Personality Disorder, run by Heidelberg University at 5 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Mentalization-Based Treatment (MBT) and Bona-Fide Treatment in Germany (BFT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
5 sitesGermany
Study dates
28 Feb 2024to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Borderline Personality Disorder
  • non-suicidal self injury or suicide attempts in the past two years as indicated by the IPDE item "repeated suicidal behaviours, gestures, threats or self-harm", one of which has occurred in the past six months

Who cannot join

  • acute substance use disorder (exception: cannabis dependency)
  • diagnosis of schizophrenia or schizotypal personality disorder
  • bipolar I disorder (DSM-5)
  • cognitive impairment (IQ<80) or evidence of organic brain disorder
  • BMI<16.5
  • serious medical condition that will require hospitalization within the next year (e.g. cancer)
  • no sufficient German language abilities

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Svenja Taubner, Prof. contact

+496221564701

svenja.taubner@med.uni-heidelberg.de

Sophie Hauschild, Dr. contact

sophie.hauschild@med.uni-heidelberg.de

5 sites in 1 country

Germany5 sites, 5 recruiting

  • Psychologische Hochschule Berlin

    Berlin

    Timo Storck, Prof.

    Anna-Maria Weiland, M. Sc.

    Recruiting

  • Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf

    Düsseldorf

    Ulrike Dinger-Ehrenthal, Prof.

    Jörg Rademacher, PD

    Not yet recruiting

  • Heidelberg University

    Heidelberg, 69115

    Svenja Taubner, Prof., Svenja.Taubner@med.uni-heidelberg.de

    Sophie Hauschild, Dr., sophie.hauschild@med.uni-heidelberg.de

    Recruiting

  • Institute for Psychosocial Medicine, Psychotherapy and Psychooncology

    Jena

    Bernhard Strauss, Prof.

    Alisa Harthaus, M. Sc.

    Not yet recruiting

  • Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm

    Ulm

    Volkert Jana, Prof.

    Not yet recruiting

Other trials in Germany

About this study

Official title: Mentalisierungsbasierte Therapie Versus Bona-fide-Therapie für Patient:Innen Mit Borderline-Persönlichkeitsstörung in Deutschland (MaGnet): Eine Prospektive, Multizentrische Randomisiert-kontrollierte Studie Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany (MAGNET): a Prospective, Multi-centre Randomized Controlled Trial

Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient settings compared with bona fide treatment (BFT) are still scarce and none has been conducted in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is more effective in the reduction of crisis events (incidences of NSSI and suicide attempts) compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany. Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and interpersonal functioning, BPD and general symptom severity, social adjustment, quality of life, reduction in psychotropic medication and therapy retention. Additionally, moderator as well as common and treatment specific mediator variables will be investigated.

Study Design/ Study Population/ Methods: Across 5 study sites in Germany, 304 individuals of all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past will be asked to participate in the study for two years. In the first year, patients will receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) four times a week once per month during the first year and once every three months in the second year. Number of crisis events up to 2 years post randomization will be compared between treatment arms using a log-linear regression model following an intention-to-treat approach. Secondary outcomes, such as borderline and general symptom severity, will be assessed at several timepoints. A within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective.

Clinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment in an outpatient setting compared with BFT in Germany. Results of this study can address a treatment gap in the German healthcare system, and inform about health economic aspects of BPD treatment as well as mechanisms of psychotherapeutic change.

Being tested
Mentalization-Based Treatment (MBT), Bona-Fide Treatment in Germany (BFT)
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 Treatment (MBT)Behavioural

    Patients in MBT will receive a maximum of 58 sessions in total. Of those, 30 are weekly individual sessions. 28 sessions are weekly group sessions conducted by two therapists, and consisting of 8 introductory sessions of group psychoeducation followed by 20 group therapy sessions. The duration of MBT is 12 months. MBT is manualized and relies on validating the emotional experience of patients that aims to promote mentalizing. The proposed mechanism of change in MBT is to stabilize mentalizing in certain focus areas in order to create a psychic buffer between affect and behaviour to foster affect regulation, reduce impulsivity and promote functional supportive relationships.

  • Bona-Fide Treatment in Germany (BFT)Behavioural

    Patients in BFT will receive one to two weekly sessions of Bona-Fide-Treatment (Psychodynamic Therapy, PT, or Cognitive Behavioural Therapy, CBT) conducted by community experts delivered as short-term psychotherapy (<24 sessions) or long-term psychotherapy (>24 sessions). BFT can be delivered as individual, group or a combination of individual and group treatment as stated in the German psychotherapy regulations.

Study groups in NCT06018272
Study groupRoleWhat they receive
Mentalization-Based Treatment (MBT)ExperimentalNot described
Receives: Behavioral: Mentalization-Based Treatment (MBT)
Bona-Fide Treatment in Germany (BFT)Active comparatorNot described
Receives: Behavioral: Bona-Fide Treatment in Germany (BFT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)

    composite score (non)suicidal self injury

    Measured: every second day during one week per month in the first year, and during one week every three months in the second year

Secondary outcomes (14)

  1. Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009)

    Measured: Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24

  2. Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)

    Measured: Day 0, Month 6, Month 12, Month 24

  3. Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)

    Measured: Day 0, Month 6, Month 12, Month 24

  4. Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)

    Measured: Day 0, Month 6, Month 12, Month 24

  5. Change in personality traits assessed with PID5BF+M (Bach et al., 2020)

    Measured: Day 0, Month 6, Month 12, Month 24

  6. Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)

    Participants are presented with 160 faces, each unambiguously showing one of four emotional expressions (angry, fearful, happy, neutral). The goal of the task is to correctly classify these facial expressions. The task's collected behavioral data encompasses two key measurements: the ratio of accurate responses (specifically, correct emotion classification) and the time it takes to respond in trials where the emotion classification is correct.

    Measured: Day 0, Month 6, Month 12, Month 24

  7. Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019)

    Measured: Day 0, Month 6, Month 12, Month 24

  8. Change in trait anger assessed with STAXI-2 (Spielberger, 1999)

    Measured: Day 0, Month 6, Month 12, Month 24

  9. Change in social adjustment assessed with WSAS (Marks, 1986)

    Measured: Day 0, Month 6, Month 12, Month 24

  10. Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021)

    Measured: Day 0, Month 6, Month 12, Month 24

  11. Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)

    Measured: Day 0, Month 6, Month 12, Month 24

  12. Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015)

    Measured: Day 0, Month 6, Month 12, Month 24

  13. Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)

    Measured: Day 0, Month 6, Month 12, Month 24

  14. Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)

    Measured: Day 0, Month 6, Month 12, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start28 Feb 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
304 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018272
Sponsor's protocol ID
500412881
Acronym
MAGNET
Status last verified
May 2024
First submitted
17 Aug 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bateman A, Fonagy P. Mentalization based treatment for borderline personality disorder. World Psychiatry. 2010 Feb;9(1):11-5. doi: 10.1002/j.2051-5545.2010.tb00255.x.

    PubMed 20148147

  • Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9. doi: 10.1176/ajp.156.10.1563.

    PubMed 10518167

  • Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.

    PubMed 19833787

  • Jorgensen CR, Freund C, Boye R, Jordet H, Andersen D, Kjolbye M. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013 Apr;127(4):305-17. doi: 10.1111/j.1600-0447.2012.01923.x. Epub 2012 Aug 17.

    PubMed 22897123

  • Laurenssen EMP, Luyten P, Kikkert MJ, Westra D, Peen J, Soons MBJ, van Dam AM, van Broekhuyzen AJ, Blankers M, Busschbach JJV, Dekker JJM. Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial. Psychol Med. 2018 Nov;48(15):2522-2529. doi: 10.1017/S0033291718000132. Epub 2018 Feb 26.

    PubMed 29478425

  • Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018.

    PubMed 23200287

  • 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.

    PubMed 32368793

  • Wittchen H-U, Zaudig M, Fydrich T. Strukturiertes Klinisches Interview für DSM-IV (SKID I und SKID II). Göttingen: Hogrefe; 1997. https://doi.org/10.1026//0084-5345.28.1.68.

  • Raven J. Raven´s Progressive Matrices 2, Clinical Edition. 1st ed. München: Pearson; 2019.

  • Gutierrez PM, Osman A, Barrios FX, Kopper BA. Development and initial validation of the Self-harm Behavior Questionnaire. J Pers Assess. 2001 Dec;77(3):475-90. doi: 10.1207/S15327752JPA7703_08.

    PubMed 11781034

  • Wolf M, Limberger MF, Kleindienst N, Stieglitz RD, Domsalla M, Philipsen A, Steil R, Bohus M. [Short version of the borderline symptom list (BSL-23): development and psychometric evaluation]. Psychother Psychosom Med Psychol. 2009 Aug;59(8):321-4. doi: 10.1055/s-0028-1104598. Epub 2009 Mar 9. German.

    PubMed 19274605

  • Lovibond SH, Lovibond PF. Manual for the Depression Anxiety & Stress Scales. 2nd ed. Sydney: Psychology Foundation; 1995.

  • Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.

    PubMed 21076562

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • EuroQol Research Foundation. EQ-5D-5L User Guide Version 3.0: Basic information on how to use the EQ-5D-5L instrument. Https://EuroqolOrg/Publications/User-Guides 2019.

Questions about this trial

What is this clinical trial studying?

A study testing Mentalization-Based Treatment (MBT) and Bona-Fide Treatment in Germany (BFT) in people with Borderline Personality Disorder, run by Heidelberg University at 5 sites in Germany.

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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Svenja Taubner, Prof. (+496221564701, svenja.taubner@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001) (time frame: every second day during one week per month in the first year, and during one week every three months in the second year). 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 NCT06018272, which also lists 46 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 10 May 2024.

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