MAGNET: Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mentalization-Based Treatment (MBT)
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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.
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| Active Comparator: Bona-Fide Treatment in Germany (BFT)
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Behavioral: 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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Outcome Measures
Primary Outcome Measures
- change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001) [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
Secondary Outcome Measures
- 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) [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.
- 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]
Other Outcome Measures
- Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021) [Month 6, Month 12]
Mediator
- Therapeutic Agency Inventory (TAI; Huber et al., 2019) [once a week in the first year and at Month 6 and Month 12]
Mediator
- Group Questionnaire - short (GQ; Jensen, 2016) [once a week in the first year and at Month 6 and Month 12]
Mediator
- Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ; Campbell et al., 2019) [Month 6, Month 12]
Mediator
- Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021) [Month 6, Month 12]
Mediator
- Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) [Month 6, Month 12]
Mediator
- Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted) [Month 6, Month 12]
Mediator
- Negative Effects Questionnaire (NEQ; Rozental et al., 2016) [Month 12]
Serious adverse events of therapy
- Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006) [once a week in the first year and at Month 6 and Month 12]
Mediator
- Symptoms of PTSD and complex PTSD and complex PTSD Trauma experiences with Internation Trauma Interview (ITI; Roberts et al., 2019) [Day 0]
Moderator
- Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018) [Day 0]
Moderator
- Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017) [Day 0]
Moderator
- Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994) [once a week in the first year and at Month 6 and Month 12]
Mediator
- Change of frequency of occurence of positive and negative automatic thoughts with Automatic Thoughts Questionnaire - Revised (ATQ-R; Kendall, 1989) [Month 6, Month 12]
Mediator
- Assessment of the frequency of alliance ruptures and resolution processes in therapy sessions with Rupture Resolution Rating System (Eubanks et al., 2015) [Month 6, Month 12]
Mediator
- Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012) [Month 6, Month 12]
Mediator
- Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017) [Month 6, Month 12]
Mediator
- Assessment of the therapists' activity and appropriateness in essential domains of MBT with the Mentalization-Based Treatment Adherence and Competence Scale (Bateman & Fonagy, 2016) [Month 6, Month 12]
Mediator
- Assessment of the therapists' adherence to psychodynamic-interpersonal and cognitive-behavioural treatments with the Comparative Psychotherapy Process Scale (Hilsenroth et al., 2005) [Month 6, Month 12]
Mediator
- Interview for treatment and study evaluation [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Borderline Personality Disorder
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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:
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acute substance use disorder (exception: cannabis dependency)
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diagnosis of schizophrenia or schizotypal personality disorder
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bipolar I disorder (DSM-5)
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cognitive impairment (IQ<80) or evidence of organic brain disorder
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BMI<16.5
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serious medical condition that will require hospitalization within the next year (e.g. cancer)
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no sufficient German language abilities
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Heidelberg University
- German Research Foundation
- Universitätsklinikum Düsseldorf
- Universitätsklinikum Jena
- Universitätsklinikum Ulm
- Medical School Berlin
Investigators
- Principal Investigator: Svenja Taubner, University Heidelberg
Study Documents (Full-Text)
None provided.More Information
Publications
- Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9. doi: 10.1176/ajp.156.10.1563.
- Bateman A, Fonagy P. Mentalization based treatment for borderline personality disorder. World Psychiatry. 2010 Feb;9(1):11-5. doi: 10.1002/j.2051-5545.2010.tb00255.x.
- Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15.
- Jorgensen CR, Freund C, Boye R, Jordet H, Andersen D, Kjolbye M. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013 Apr;127(4):305-17. doi: 10.1111/j.1600-0447.2012.01923.x. Epub 2012 Aug 17.
- Laurenssen EMP, Luyten P, Kikkert MJ, Westra D, Peen J, Soons MBJ, van Dam AM, van Broekhuyzen AJ, Blankers M, Busschbach JJV, Dekker JJM. Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial. Psychol Med. 2018 Nov;48(15):2522-2529. doi: 10.1017/S0033291718000132. Epub 2018 Feb 26.
- Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018.
- Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
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