NCT06018272: MAGNET

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

Recruiting now NA Last updated 10 May 2024

What this trial tests

NA trial testing Mentalization-Based Treatment (MBT) in Borderline Personality Disorder in 304 participants. Currently enrolling.

Timeline

28 February 2024

Primary endpoint
30 September 2027

31 March 2028

Quick facts

Lead sponsor	Heidelberg University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	304
Start date	28 February 2024
Primary completion	30 September 2027
Estimated completion	31 March 2028
Sites	5 locations across Germany

Drugs / interventions tested

• Mentalization-Based Treatment (MBT)
• Bona-Fide Treatment in Germany (BFT)

Conditions studied

• Borderline Personality Disorder — all drugs for Borderline Personality Disorder →

Sponsor

Heidelberg University

Who can join

Adults 18 to 65, any sex, with Borderline Personality Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial.
   Hauschild S, Taubner S, Vidalón Blachowiak T, Dinger U, et al · · 2025 · PMID 40217262 · DOI 10.1186/s12888-025-06809-0