Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial

Abstract

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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3306-7) contains supplementary material, which is available to authorized users.

Personality Functioning and Mentalizing in Patients With Subthreshold or Diagnosed Borderline Personality Disorder: Implications for ICD-11

“…A cross-sectional design was employed with a sample of adult participants with subthreshold (four of nine criteria according to the DSM-5) or diagnosed BPD. We used baseline data from a randomized clinical trial (RCT) assessing the effects of shortterm vs. long-term mentalization-based therapy for outpatients with subthreshold or diagnosed BPD (44). At the time the present study was conducted the inclusion of patients to the RCT was ongoing, hence the data used here is from patients recruited from September 2018 to December 2019.…”

A service evaluation of short-term mentalisation based treatment for personality disorder

“…Juul et al proposed an RCT to examine this point in BPD. 32 Future work targeting a mixed cohort of people with personality disorder is also required to confirm the present findings suggesting symptom improvement at post-intervention.…”

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)

“…The design of the MBT-RCT trial has been described in detail previously [ 3 ]. The trial population will be adults (18 years of age or older) with subthreshold or diagnosed borderline personality disorder assessed with the Structural Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD).…”

“…The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial with the objectives to assess the beneficial and harmful effects of short-term (20 weeks) compared with long-term (14 months) MBT for outpatients with subthreshold or diagnosed borderline personality disorder [ 3 ]. The Helsinki Declaration [ 4 ] and the International Conference on Harmonization of Good Clinical Practice (ICH-GCP) [ 5 ] Guidelines recommend that clinical trials should be analysed according to a pre-specified plan to prevent selective outcome reporting bias and data-driven analysis results [ 6 – 8 ].…”