- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06018272
Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany (MAGNET)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Svenja Taubner, Prof.
- Phone Number: +496221564701
- Email: svenja.taubner@med.uni-heidelberg.de
Study Contact Backup
- Name: Sophie Hauschild, Dr.
- Email: sophie.hauschild@med.uni-heidelberg.de
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Active Comparator: 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.
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What is the study measuring?
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)
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
|
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)
Time Frame: Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24
|
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)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in personality traits assessed with PID5BF+M (Bach et al., 2020)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
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)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in trait anger assessed with STAXI-2 (Spielberger, 1999)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in social adjustment assessed with WSAS (Marks, 1986)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
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)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
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)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
|
Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)
Time Frame: Day 0, Month 6, Month 12, Month 24
|
Day 0, Month 6, Month 12, Month 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Therapeutic Agency Inventory (TAI; Huber et al., 2019)
Time Frame: once a week in the first year and at Month 6 and Month 12
|
Mediator
|
once a week in the first year and at Month 6 and Month 12
|
Group Questionnaire - short (GQ; Jensen, 2016)
Time Frame: once a week in the first year and at Month 6 and Month 12
|
Mediator
|
once a week in the first year and at Month 6 and Month 12
|
Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Negative Effects Questionnaire (NEQ; Rozental et al., 2016)
Time Frame: Month 12
|
Serious adverse events of therapy
|
Month 12
|
Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006)
Time Frame: once a week in the first year and at Month 6 and Month 12
|
Mediator
|
once a week in the first year and at Month 6 and Month 12
|
Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019)
Time Frame: Day 0
|
Moderator
|
Day 0
|
Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
Time Frame: Day 0
|
Moderator
|
Day 0
|
Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)
Time Frame: Day 0
|
Moderator
|
Day 0
|
Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)
Time Frame: once a week in the first year and at Month 6 and Month 12
|
Mediator
|
once a week in the first year and at Month 6 and Month 12
|
Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman & Fonagy, 2016)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005)
Time Frame: Month 6, Month 12
|
Mediator
|
Month 6, Month 12
|
Interview for treatment and study evaluation
Time Frame: Month 24
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Svenja Taubner, University Heidelberg
Publications and helpful links
General Publications
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- Bach B, Kerber A, Aluja A, Bastiaens T, Keeley JW, Claes L, Fossati A, Gutierrez F, Oliveira SES, Pires R, Riegel KD, Rolland JP, Roskam I, Sellbom M, Somma A, Spanemberg L, Strus W, Thimm JC, Wright AGC, Zimmermann J. International Assessment of DSM-5 and ICD-11 Personality Disorder Traits: Toward a Common Nosology in DSM-5.1. Psychopathology. 2020;53(3-4):179-188. doi: 10.1159/000507589. Epub 2020 May 5.
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- Talia A, Miller-Bottome M. Patient Attachment Coding System, 2.0 (Unpublished manuscript). Deparment of Psychology: University of Copenhagen 2012.
- Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
- Krause Jacob M, Abarzúa M, Silva M, Navarro D, Altimir Colao C. Psychotherapie aus der Sicht von Klienten mit Schizophrenie. Verhaltenstherapie & Psychosoziale Praxis 2016;47:63-76.
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- Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the Working Alliance Inventory. Psychotherapy Research. 2006; 16: 12-25.
- Huber J, Nikendei C, Ehrenthal JC, Schauenburg H, Mander J, Dinger U. Therapeutic Agency Inventory: Development and psychometric validation of a patient self-report. Psychother Res. 2019 Oct;29(7):919-934. doi: 10.1080/10503307.2018.1447707. Epub 2018 Mar 20.
- Muller S, Wendt LP, Zimmermann J. Development and Validation of the Certainty About Mental States Questionnaire (CAMSQ): A Self-Report Measure of Mentalizing Oneself and Others. Assessment. 2023 Apr;30(3):651-674. doi: 10.1177/10731911211061280. Epub 2021 Dec 14.
- Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.
- Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. J Psychopathol Behav Assess. 2004; 26: 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500412881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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