Dataset Information

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).

ABSTRACT:

Background

Psychotherapy 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/design

The 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 registration

ClinicalTrials.gov NCT03677037 . Registered on 19 September 2018.

SUBMITTER: Juul S

PROVIDER: S-EPMC8316699 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionBorderline personality disorder (BPD) is a severe and prevalent psychiatric disorder. Mentalization-based therapy (MBT) is an evidence-based intervention for BPD, and several countries offer treatment programs for BPD lasting for years, which is resource demanding. No previous trial has compared short-term with long-term MBT.ObjectiveThe aim of the study was to assess the efficacy and safety of short-term versus long-term MBT for outpatients with BPD.MethodsAdult outpatients (≥18 years) with subthreshold or diagnosed BPD were randomly assigned (1:1) to short-term MBT (5 months) or long-term MBT (14 months). The primary outcome was BPD symptoms assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes were functional impairment, quality of life, global functioning, and severe self-harm. All outcomes were primarily assessed at 16 months after randomization. This trial was prospectively registered at <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>, NCT03677037.ResultsBetween October 4, 2018, and December 3, 2020, we randomly assigned 166 participants to short-term MBT (n = 84) or long-term MBT (n = 82). Regression analyses showed no evidence of a difference when assessing BPD symptoms (MD 0.99; 95% CI: -1.06 to 3.03; p = 0.341), level of functioning (MD 1.44; 95% CI: -1.43 to 4.32; p = 0.321), quality of life (MD -0.91; 95% CI: -4.62 to 2.79; p = 0.626), global functioning (MD -2.25; 95% CI: -6.70 to 2.20; p = 0.318), or severe self-harm (RR 1.37; 95% CI: 0.70-2.84; p = 0.335). More participants in the long-term MBT group had a serious adverse event compared with short-term MBT (RR 1.63; 95% CI: 0.94-3.07; p = 0.088), primarily driven by a difference in psychiatric hospitalizations (RR 2.03; 95% CI: 0.99-5.09; p = 0.056).ConclusionLong-term MBT did not lead to lower levels of BPD symptoms, nor did it influence any of the secondary outcomes compared with short-term MBT.

Project description:BACKGROUND:Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. However, the current length of outpatient treatments is arbitrary and based on trials that never tested if the treatment intensity could be reduced. As a result, there is insufficient evidence to inform the decision between short-term and long-term psychotherapy for borderline personality disorder. Mentalization-based therapy is one treatment option for borderline personality disorder and consists traditionally of an 18-month treatment program. METHODS/DESIGN:This trial is an investigator-initiated single-center randomized clinical superiority trial of short-term (20?weeks) compared to long-term (14?months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be included if they meet a minimum of four DSM-V criteria for borderline personality disorder. Participants will be assessed before randomization, and at 8, 16, and 24?months after randomization. The primary outcome is severity of borderline symptomatology assessed with the Zanarini Rating Scale for borderline personality disorder. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale, Global Assessment of Functioning) and quality of life (Short-Form Health Survey 36). Severity of psychiatric symptoms (Symptom Checklist 90-R) will be included as an exploratory outcome. Measures of personality functioning, attachment, borderline symptoms, group alliance, and mentalization skills will be included to explore potential predictors and mechanisms of change. DISCUSSION:This trial will provide evidence of the beneficial and harmful effects of short-term compared to long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03677037 . Registered on September 19, 2018.