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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Mentalization-Based Treatment (MBT)
* Behavioral: Bona-Fide Treatment in Germany (BFT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mentalization-Based Treatment (MBT)<br> | Behavioral: Mentalization-Based Treatment (MBT)<br>* 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.<br>|
| Active Comparator: Bona-Fide Treatment in Germany (BFT)<br> | Behavioral: Bona-Fide Treatment in Germany (BFT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one week each month for 24 months OR every second day, one week per month in the first year and one week every three months in the second year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009) |  | Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24 | 
| Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in personality traits assessed with PID5BF+M (Bach et al., 2020) |  | Day 0, Month 6, Month 12, Month 24 | 
| 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. | Day 0, Month 6, Month 12, Month 24 | 
| Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in trait anger assessed with STAXI-2 (Spielberger, 1999) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in social adjustment assessed with WSAS (Marks, 1986) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018) |  | Day 0, Month 6, Month 12, Month 24 | 
| Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015) |  | Day 0, Month 6, Month 12, Month 24 | 
| Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015) |  | Day 0, Month 6, Month 12, Month 24 | 
| Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003) |  | Day 0, Month 6, Month 12, Month 24 |