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

Borderline Personality Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018272
• Other study ID #: 500412881
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: Heidelberg University
• Contact: Svenja Taubner, Prof.
• Phone: +496221564701
• Email: svenja.taubner[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: March 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Mentalization-Based Treatment (MBT)
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)
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.

Locations

Country	Name	City	State
Germany	Psychologische Hochschule Berlin	Berlin
Germany	Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf	Düsseldorf
Germany	Heidelberg University	Heidelberg
Germany	Institute for Psychosocial Medicine, Psychotherapy and Psychooncology	Jena
Germany	Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm	Ulm

Sponsors (6)

Lead Sponsor	Collaborator
Heidelberg University	German Research Foundation, Psychologische Hochschule Berlin, Universitätsklinikum Düsseldorf, Universitätsklinikum Jena, Universitätsklinikum Ulm

Country where clinical trial is conducted

Germany, 

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)	Mediator	Month 6, Month 12
Other	Therapeutic Agency Inventory (TAI; Huber et al., 2019)	Mediator	once a week in the first year and at Month 6 and Month 12
Other	Group Questionnaire - short (GQ; Jensen, 2016)	Mediator	once a week in the first year and at Month 6 and Month 12
Other	Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019)	Mediator	Month 6, Month 12
Other	Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)	Mediator	Month 6, Month 12
Other	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	Mediator	Month 6, Month 12
Other	Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)	Mediator	Month 6, Month 12
Other	Negative Effects Questionnaire (NEQ; Rozental et al., 2016)	Serious adverse events of therapy	Month 12
Other	Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006)	Mediator	once a week in the first year and at Month 6 and Month 12
Other	Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019)	Moderator	Day 0
Other	Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)	Moderator	Day 0
Other	Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)	Moderator	Day 0
Other	Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)	Mediator	once a week in the first year and at Month 6 and Month 12
Other	Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989)	Mediator	Month 6, Month 12
Other	Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015)	Mediator	Month 6, Month 12
Other	Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012)	Mediator	Month 6, Month 12
Other	Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017)	Mediator	Month 6, Month 12
Other	Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman & Fonagy, 2016)	Mediator	Month 6, Month 12
Other	Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005)	Mediator	Month 6, Month 12
Other	Interview for treatment and study evaluation	Semi-structured interview developed based on Krause et al. 2016 will be used to assess how patients experienced the therapy and the study, what aspects they perceived as positive or negative, and what impact the therapy had on their symptoms and their life	Month 24
Primary	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	every second day during one week per month in the first year, and during one week every three months in the second year
Secondary	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
Secondary	Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)		Day 0, Month 6, Month 12, Month 24
Secondary	Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)		Day 0, Month 6, Month 12, Month 24
Secondary	Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)		Day 0, Month 6, Month 12, Month 24
Secondary	Change in personality traits assessed with PID5BF+M (Bach et al., 2020)		Day 0, Month 6, Month 12, Month 24
Secondary	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
Secondary	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
Secondary	Change in trait anger assessed with STAXI-2 (Spielberger, 1999)		Day 0, Month 6, Month 12, Month 24
Secondary	Change in social adjustment assessed with WSAS (Marks, 1986)		Day 0, Month 6, Month 12, Month 24
Secondary	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
Secondary	Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)		Day 0, Month 6, Month 12, Month 24
Secondary	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
Secondary	Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)		Day 0, Month 6, Month 12, Month 24
Secondary	Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)		Day 0, Month 6, Month 12, Month 24