An interventional study of Mentalization-Based Treatment (MBT) and Bona-Fide Treatment in Germany (BFT) in Borderline Personality Disorder, sponsored by Heidelberg University. Recruiting at 5 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment
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.
336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.
This study's planned enrollment of 304 is above the median of 75 across 229 interventional studies indexed under Personality Disorders.
Browse Personality Disorders studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Behavioral: Mentalization-Based Treatment (MBT)
Behavioral: Bona-Fide Treatment in Germany (BFT)
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.
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.
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
Time frame: every second day during one week per month in the first year, and during one week every three months in the second year
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
Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)
Time frame: 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
Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)
Time frame: 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
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.
Time frame: 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
Change in trait anger assessed with STAXI-2 (Spielberger, 1999)
Time frame: 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
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
Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)
Time frame: 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
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
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
Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)
Mediator
Time frame: Month 6, Month 12
Therapeutic Agency Inventory (TAI; Huber et al., 2019)
Mediator
Time frame: once a week in the first year and at Month 6 and Month 12
Group Questionnaire - short (GQ; Jensen, 2016)
Mediator
Time frame: 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)
Mediator
Time frame: Month 6, Month 12
Experiences in Close Relationships-Revised Screening Version (ECR-RD8; Ehrenthal et al., 2021)
Mediator
Time frame: Month 6, Month 12
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Mediator
Time frame: Month 6, Month 12
Mentalizing as mediator of change assessed with Mentalizing Emotions Questionnaire (Kasper et al., submitted)
Mediator
Time frame: Month 6, Month 12
Negative Effects Questionnaire (NEQ; Rozental et al., 2016)
Serious adverse events of therapy
Time frame: Month 12
Therapeutic Alliance as mediator of change assessed with Working Alliance Inventory (WAI-SR, Hatcher & Gillaspy, 2006)
Mediator
Time frame: 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)
Moderator
Time frame: Day 0
Symptoms of PTSD and complex PTSD with International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
Moderator
Time frame: Day 0
Level of personality functioning with Semi-Structured Interview for Personality Functioning DSM-5 (STiP; Hutsebaut et al., 2017)
Moderator
Time frame: Day 0
Change of pleasure, arousal and dominance with Self-Assessment Manikin (Bradley, 1994)
Mediator
Time frame: 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)
Mediator
Time frame: 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)
Mediator
Time frame: Month 6, Month 12
Assessment of the clients'attachment style with the Patient Attachment Coding System (Talia & Miller-Bottome, 2012)
Mediator
Time frame: Month 6, Month 12
Assessment of the therapists' attunement and attachment status with the Therapist Attunement Scales (Talia & Muzi, 2017)
Mediator
Time frame: 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)
Mediator
Time frame: 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)
Mediator
Time frame: Month 6, Month 12
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
Time frame: Month 24
Plan to share: No
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