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

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT)

“…Participants allocated to short-term MBT attended a mean (SD) of 12 (6.2) individual therapy sessions and 14 (6.9) group sessions over a period of 5 months. Participants allocated to long-term MBT attended a mean of 17 (11) individual therapy sessions and 24 (14) group sessions over a period of 14 months. Attendance data were missing for 21 participants.…”

Improving the methodological quality of randomized clinical trials assessing psychotherapy for borderline personality disorder: Recommendations for the future

“…Based on these methodological assessments ( 5 ) combined with my personal experiences with conducting a randomized clinical trial assessing psychotherapy for BPD ( 10 , 11 ), I will in the following present some key methodological limitations along with recommendations to improve clinical research, particularly individual, parallel-group, randomized clinical trial methodology, within the field.…”

Mentalizing the patient–Patient experiences with short-term mentalization-based therapy for borderline personality disorder: A qualitative study

“…Recently, a short-term version of MBT has been developed to treat outpatients with BPD (3,5,7). The short-term MBT version was developed as a part of a randomized clinical trial assessing the beneficial and harmful effects of short-term versus long-term MBT for outpatients with subthreshold or diagnosed BPD (3,5,7). The short-term adaptation is a 20-week program that is overall similar to the original long-term program, but differs in regard to certain parameters: (1) short-term MBT is lower in treatment intensity, i.e., duration (5 versus 14 months), (2) the same therapists provide both individual-and group therapy in short-term MBT (i.e., combined psychotherapy), (3) short-term MBT is structured in closed groups where all participants starts and finish together, and (4) consists of brief psychoeducation (5 weeks) in the beginning, which is delivered in the group.…”

“…Mentalization-based therapy is a manualized and structured psychotherapy approach, rooted in attachment and psychodynamic theory, that was originally developed specifically for patients with BPD ( 4 , 5 ). Mentalization refers to the capacity to reflect upon and understand one’s own and other’s mental states, i.e., thoughts, feelings, and desires ( 4 ).…”

“…Recently, a short-term version of MBT has been developed to treat outpatients with BPD ( 3 , 5 , 7 ). The short-term MBT version was developed as a part of a randomized clinical trial assessing the beneficial and harmful effects of short-term versus long-term MBT for outpatients with subthreshold or diagnosed BPD ( 3 , 5 , 7 ).…”