Trial reportTrials2021
Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT).
Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03677037 (Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The difference between shorter- versus longer-term psychotherapy for adult mental health disorders: a systematic review with meta-analysis.BMC psychiatry · 2023Pooled it
- Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT).Psychotherapy and psychosomatics · 2023Trial
- Article
- Protocol for a cohort comparison treatment study evaluating the efficacy of a dimensional adaptation of GPM (GPM-extended) compared to a classic outpatient GPM treatment for patient fulfilling criteria for BPD: the EPSYLIA project.Frontiers in psychiatry · 2025Article
- Perinatal emotional skills groups for women and birthing people with borderline personality disorder: outcomes from a feasibility randomised controlled trial.BJPsych open · 2024Article
- Mentalizing and epistemic trust as critical success factors in psychosomatic rehabilitation: results of a single center longitudinal observational study.Frontiers in psychiatry · 2023Article
- Article
- Measuring Impairments of Mentalization with the 15-Item Mentalization Questionnaire (MZQ) and Introducing the MZQ-6 Short Scale: Reliability, Validity and Norm Values Based on a Representative Sample of the German Population.Diagnostics (Basel, Switzerland) · 2022Article
- Improving the methodological quality of randomized clinical trials assessing psychotherapy for borderline personality disorder: Recommendations for the future.Frontiers in psychiatry · 2022Article
- Mentalizing the patient-Patient experiences with short-term mentalization-based therapy for borderline personality disorder: A qualitative study.Frontiers in psychiatry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundPsychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown. METHODS/
designThe Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36-mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan. DISCUSSION: We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.
trial registrationClinicalTrials.gov NCT03677037 . Registered on 19 September 2018.
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