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

Primary Purpose

Borderline Personality Disorder

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mentalization-Based Treatment (MBT)

Bona-Fide Treatment in Germany (BFT)

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mentalization-Based Treatment (MBT)

Bona-Fide Treatment in Germany (BFT)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT06018272

First Posted

August 17, 2023

Last Updated

August 29, 2023

Sponsor

Heidelberg University

Collaborators

German Research Foundation, Universitätsklinikum Düsseldorf, Universitätsklinikum Jena, Universitätsklinikum Ulm, Medical School Berlin

1. Study Identification

Unique Protocol Identification Number

NCT06018272

Brief Title

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

Acronym

MAGNET

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

September 30, 2027 (Anticipated)

Study Completion Date

March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

Collaborators

German Research Foundation, Universitätsklinikum Düsseldorf, Universitätsklinikum Jena, Universitätsklinikum Ulm, Medical School Berlin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Personality Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mentalization-Based Treatment (MBT)

Arm Type

Experimental

Arm Title

Bona-Fide Treatment in Germany (BFT)

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Mentalization-Based Treatment (MBT)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Bona-Fide Treatment in Germany (BFT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

composite score (non)suicidal self injury

Time Frame

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 Measure Information:

Title

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

Time Frame

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

Title

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

Time Frame