Clinical trial NCT06018272: Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany
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
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University Düsseldorf
name: Jena University Hospital
name: Universitätsklinikum Ulm
name: Psychologische Hochschule Berlin
First posted: 2023-08-30
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)
timeFrame: 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:
measure: Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009)
timeFrame: Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24
measure: Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in personality traits assessed with PID5BF+M (Bach et al., 2020)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in trait anger assessed with STAXI-2 (Spielberger, 1999)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in social adjustment assessed with WSAS (Marks, 1986)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)
timeFrame: Day 0, Month 6, Month 12, Month 24
measure: Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)
timeFrame: Day 0, Month 6, Month 12, Month 24
Other outcomes:
measure: Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)
timeFrame: Month 6, Month 12
measure: Therapeutic Agency Inventory (TAI; Huber et al., 2019)
timeFrame: once a week in the first year and at Month 6 and Month 12
measure: Group Questionnaire - short (GQ; Jensen, 2016)
timeFrame: once a week in the first year and at Month 6 and Month 12
measure: Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019)
timeFrame: Month 6, Month 12
measure: Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)
timeFrame: Month 6, Month 12
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
timeFrame: Month 6, Month 12
measure: Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)
timeFrame: Month 6, Month 12
measure: Negative Effects Questionnaire (NEQ; Rozental et al., 2016)
timeFrame: Month 12
measure: Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006)
timeFrame: once a week in the first year and at Month 6 and Month 12
measure: Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019)
timeFrame: Day 0
measure: Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
timeFrame: Day 0
measure: Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)
timeFrame: Day 0
measure: Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)
timeFrame: once a week in the first year and at Month 6 and Month 12
measure: Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989)
timeFrame: Month 6, Month 12
measure: Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015)
timeFrame: Month 6, Month 12
measure: Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012)
timeFrame: Month 6, Month 12
measure: Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017)
timeFrame: Month 6, Month 12
measure: Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman & Fonagy, 2016)
timeFrame: Month 6, Month 12
measure: Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005)
timeFrame: Month 6, Month 12
measure: Interview for treatment and study evaluation
timeFrame: Month 24
Locations:
city: Berlin
country: Germany
facility: Psychologische Hochschule Berlin
city: Düsseldorf
country: Germany
facility: Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf
city: Heidelberg
country: Germany
facility: Heidelberg University
city: Jena
country: Germany
facility: Institute for Psychosocial Medicine, Psychotherapy and Psychooncology
city: Ulm
country: Germany
facility: Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm
Study officials:
affiliation: University Heidelberg
name: Svenja Taubner
role: PRINCIPAL_INVESTIGATOR
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